concept pilot pro names

PDUFA PILOT
PROJECT
PROPRIETARY NAME REVIEW
CONCEPT PAPER

September 2008

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PDUFA PILOT PROJECT
PROPRIETARY NAME REVIEW
CONCEPT PAPER

TABLE OF CONTENTS
I.

INTRODUCTION ..........................................................................................................................................1

II.

BACKGROUND .............................................................................................................................................2
A.
B.
C.
D.

III.

MEDICATION ERRORS .....................................................................................................................................2
2003 FDA PUBLIC MEETINGS ON DRUG NAMING...........................................................................................4
DECEMBER 2003 MEETING .............................................................................................................................5
JUNE 2008 MEETING .......................................................................................................................................5
PDUFA PILOT PROGRAM—LOGISTICS................................................................................................6

A.
B.
C.
D.
E.
F.
G.
H.
I.
IV.

WHAT ARE THE GENERAL LOGISTICS OF THE PILOT PROGRAM? ....................................................................6
HOW WILL THE PILOT PROGRAM FUNCTION?.................................................................................................7
WHAT IF I WANT TO DEVIATE FROM THE PROCESS IN THE CONCEPT PAPER? .................................................7
WHY DO I HAVE TO MAKE TWO SUBMISSIONS?.............................................................................................8
WHAT HAPPENS TO MY SUBMISSION AND HOW WILL IT BE REVIEWED? ......................................................8
WILL IND AND NDA/BLA SUBMISSIONS BE HANDLED DIFFERENTLY? ........................................................9
WHAT WILL THE AGENCY REVIEW IN DETERMINING A PROPOSED NAME'S ACCEPTABILITY? .......................9
WHAT IF MY FIRST CHOICE NAME IS NOT ACCEPTABLE? ..............................................................................9
WHEN AND HOW WILL THE PILOT PROGRAM BE ASSESSED? .......................................................................10
ASSESSING PROPOSED PROPRIETARY NAMES IN PILOT PROGRAM......................................10

A.

SAFETY REVIEW ...........................................................................................................................................11
Preliminary Screening ............................................................................................................................11
USAN Stem Search..................................................................................................................................13
Orthographic and Phonological Similarities..........................................................................................13
Computational Methods..........................................................................................................................15
Medication Error Data ...........................................................................................................................16
Name Simulation Studies ........................................................................................................................17
Failure Mode and Effects Analysis .........................................................................................................21
Nonprescription Drug Products Analysis ...............................................................................................24
B.
PROMOTIONAL REVIEW (OPTIONAL) ............................................................................................................25
1.
Participation in the Promotional Review Element of the Pilot Program................................................25
2.
Evaluation...............................................................................................................................................26
3.
Research Methodology............................................................................................................................26
1.
2.
3.
4.
5.
6.
7.
8.

V.

WHAT WILL FDA CONSIDER WHEN EVALUATING PILOT SUBMISSIONS?............................30
A.
B.
C.

STANDARDS ..................................................................................................................................................30
ASSESSING THE DATA, METHODS, AND EVALUATION ..................................................................................30
INCREASING TRANSPARENCY ........................................................................................................................31

APPENDIX A: COMPUTERIZED RESOURCES ...............................................................................................33
APPENDIX B:

PROPOSED TEMPLATE FOR A PILOT PROGRAM SUBMISSION..............................36

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PDUFA Pilot
Project
Proprietary Name Review

I.

INTRODUCTION

On September 27, 2007, President Bush signed into law the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85, 121 Stat. 823 (FDAAA)), which includes the
reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA IV). The
reauthorization of PDUFA significantly broadens and strengthens the Food and Drug
Administration's (FDA) drug safety program, facilitating more efficient development of safe and
effective new medications for the American public. As part of the reauthorization of PDUFA
IV, FDA committed to certain performance goals in its goals letter. 1 As one of these goals, FDA
stated that it would use user fees to implement various measures to reduce medication errors
related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms,
dose designations, and error-prone label and packaging designs.
In addition, FDA agreed to develop and implement a pilot program to enable pharmaceutical
firms participating in the pilot to evaluate proposed proprietary names and to submit the data
generated from those evaluations to the FDA for review. 2 In accordance with these goals, FDA
has developed and will implement such a pilot program. Using best practices when carrying out
their own proprietary name reviews and providing FDA with the data that result from those
reviews may help pharmaceutical firms choose appropriate proprietary names for their products
before application submission. The goals of the program are to minimize the use of names that
are misleading or that are likely to lead to medication errors, to make FDA's application review
more efficient, and to make regulatory decisions more transparent. At the end of the pilot, FDA
will evaluate the results to determine whether the model of industry conducting reviews,
submitting the results to FDA, and FDA reviewing the data is feasible and a better model than
FDA conducting de novo reviews of proprietary names.

1 See goals letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health,

Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the
House of Representatives, as set forth in the Congressional Record, at http://www.fda.gov/oc/pdufa4/pdufa4goals.html.
2 For more on FDAAA, PDUFA 4, and the goals letter, see http://www.fda.gov/oc/pdufa/default.htm.

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FDA has identified the following goals for the pilot program as part of the process of fulfilling
the provisions of the goals letter:
1. Hold a public technical meeting (held June 2008) to discuss the planned pilot program and
the reviews that will be completed as part of the pilot program
2. Make available by the end of FY 2008 a concept paper describing the pilot and the
proprietary submissions that will be made as part of the pilot (this concept paper)
3. Begin enrollment into the pilot program by the end of FY 2009
4. Evaluate the pilot program by the end of FY 2011 (or subsequent to accruing two years of
experience with pilot program submissions) to determine whether it is feasible and
efficient to have applicants perform their own name analysis and submit resulting data to
FDA
II.

BACKGROUND

During the past two decades, FDA has considered the role of names and naming processes in
medication errors as part of the Agency's focus on the safe use of medical products. FDA has
developed internal procedures and processes that are part of its marketing application review
process for evaluating the potential for a proposed product name (submitted as part of a new drug
application (NDA), biologics license application (BLA), or abbreviated new drug application
(ANDA)) to cause or contribute to medication errors. The goal of this pilot program is to test a
process that could enable pharmaceutical manufacturers to carry out proprietary name reviews of
their products prior to submitting marketing applications to FDA, so that the FDA review of
proprietary names would be more efficient.
The following discussion reviews briefly how naming can contribute to medication errors and
what recent activities have lead to current efforts to involve product sponsors in the drug name
review process.
A.

Medication Errors

The FDA uses the definition of a medication error as set forth by the National Coordinating
Council for Medication Error Reporting and Prevention (NCC MERP). Specifically, a
medication error is “any preventable event that may cause or lead to inappropriate medication
use or patient harm while the medication is in the control of the healthcare professional, patient,
or consumer. Such events may be related to professional practice, healthcare products,
procedures, and systems, including prescribing; order communication; product labeling,
packaging, and nomenclature; compounding; dispensing; distribution; administration; education;
3
monitoring; and use.” It is important to note that some medication errors might be preventable

3 National Coordinating Council for Medication Error Reporting and Prevention (Definition of Medication Error) at
http://www.nccmerp.org/aboutMedErrors.html.

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events and that the risk of these errors might be detected in the premarket stage of product
development using appropriate evaluation methods.
Medication use errors may occur due to sound-alike or look-alike names, unclear labels, or
4
poorly designed packaging. In the U.S. healthcare system, healthcare practitioners rely on a
product’s name as the critical identifier of the appropriate therapy in a market of thousands of
products. Therefore, accurate interpretation of a product's name is essential to ensure that the
correct product is procured, prescribed, prepared, dispensed, and administered to the patient.
Product names that look or sound alike can lead to medication errors and, potentially, to patient
harm by increasing the risk of a healthcare practitioner’s misprescribing or misinterpreting the
correct product name, dispensing and/or administering the wrong product, or dispensing it
incorrectly.
Because product name confusion can occur at any point in the medication use process, FDA
considers the potential for confusion throughout the entire U.S. healthcare system, including
product procurement, prescribing/ordering, dispensing, administration, and monitoring the
5
effects of a medication.
Medication use within a healthcare organization can be viewed as a system, with several
components and processes: inputs (patient and drug therapy information), throughputs (care
6
provided), and outputs (effective, efficient, and safe treatment). Depending on the setting and
organization, there are many variables potentially interacting within this system. Such variables
may include, but are not limited to:
•
•
•
•
•
•
•

Different processes and procedures
Different types of healthcare practitioners involved
Different patients
Different products
Different storage and dispensing conditions
Different available technologies
Different environmental conditions such as lighting, distractions, and workload

Because of the many potential interactions among the system elements, multiple opportunities
for medical care-related confusion and medication errors exist.
This concept paper explains how an applicant who chooses to participate in the pilot program
could assess a proposed proprietary name for safety (i.e., potential for medication errors), and, at
the applicant's option, for promotional implications, before application approval and subsequent

4 Institute of Medicine, To Err is Human – Building a Safer Health System (1999).
5 Institute of Medicine, Preventing Medication Errors.
6 Joint Commission on Accreditation of Healthcare Organizations, Medication Use: A Systems Approach to

Reducing Errors.
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marketing of a product in the United States and submit the results of the assessment for review
under the planned program, as outlined in the goals letter.
As described more fully in the next section, the evaluation of proprietary names has been
discussed numerous times in the past.
B.

2003 FDA Public Meetings on Drug Naming

In June 2003, the FDA, together with the Institute for Safe Medication Practices (ISMP) and the
Pharmaceutical Research and Manufacturers of America (PhRMA), held a public meeting to
discuss the proper approach to proprietary name evaluation. This meeting was the first public
discussion of current methods to screen potential proprietary drug names for similarities to
names of currently marketed drugs. Much of the information on the FDA’s name evaluation
process presented at the meeting is available on the FDA Web site. 7 Specific topics discussed at
the June 2003 meeting included:
•

The size, qualifications, and best use of internal expert teams to evaluate proprietary
names

•

Challenges in designing questionnaires for the assessment of proprietary names

•

The methodology for conducting a Failure Mode and Effects Analysis (FMEA)

•

Handwritten prescription and medication requisition recognition techniques

•

Use of computational linguistic methods and string matching to identify sound-alike or
look-alike proprietary names

•

Sampling frames and methods to identify name evaluation study participants

•

Use of computer-assisted decision analysis tools

At the June 2003 public meeting, many meeting participants offered these views:
•

Prescription and order simulations should reflect actual situations as much as possible.

•

Simulations should replicate medication order situations with known error vulnerabilities.

•

The risk of a medication error can be increased or reduced, depending upon how
medication orders are communicated (e.g., oral, written, physician order entry, or
electronic prescribing).

•

Simulations should include not only the product name, but also the strength, route of
administration, quantity to dispense, directions for use, and patient age and weight (for
pediatric patients).

•

Nonprescription (over-the-counter or OTC) drug products should also be subject to the
same proprietary name testing standards as prescription drug products.

7 See http://www.fda.gov/cder/meeting/drugNaming.htm.
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More global issues were also discussed at the meeting. Specifically, stakeholders in the drug
application process indicated that they consider the current proprietary name testing approach to
be only qualitative in nature. The processes and outcomes of the Agency’s’ proprietary name
review were perceived as inconsistent across reviews and FDA approval units, and most of the
current approaches to proprietary name reviews could not be validated or reproduced. Because
of these issues, the stakeholders and FDA expressed the opinion that there is no gold standard
for testing proprietary drug product names to assess the risk of error. However, all of the
methods discussed were considered to offer value in the name testing process and, in the absence
of a gold standard, participants stated that multiple tests should be conducted complementarily
with a systematic approach, and standardized tools should be applied.
C.

December 2003 Meeting

In December 2003, FDA held a meeting of its Drug Safety and Risk Management Advisory
Committee (DSARM). At that meeting, the June 2003 public meeting results were reviewed,
additional topics in proprietary name evaluation testing were presented, and public comments
were elicited. Materials from the December 2003 meeting are available on the FDA Web site. 8
At the December meeting, the DSARM concluded that, although the current name testing
approaches appeared logical and were under refinement, a scientifically valid, outcomes-based,
data-driven approach to analyzing proprietary drug product names still did not exist.
D.

June 2008 Meeting

A third public meeting was held June 5 and 6, 2008, which focused on subsequent developments
in the science and practice of proprietary name analysis since the 2003 meetings, the strength of
evidence for the current approaches to name review for both prescription and nonprescription
products as discussed in the draft of this concept paper, the elements of best practice in testing in
the absence of a gold standard, and on details of how the planned pilot program should be
structured and evaluated. Comments on the proposed pilot were also filed in Docket number
FDA-2008-N-0281 after the public meeting.
All of the proposed evaluation methods were judged by individual experts participating in the
public meeting to be complementary and considered to offer value in the name testing process.
One new method was proposed, Socio-Technical Probabilistic Risk Assessment (STPRA), as an
emerging tool for consideration. 9 Many commenters encouraged FDA to incorporate consumers
as well as frontline practitioners in every name evaluation. Many commenters also recommended
that OTC proprietary names be screened using both consumer and healthcare-based testing
because many of these products are recommended by healthcare practitioners and are used in
inpatient and long-term care settings.
This concept paper incorporates changes made in response to the comments made at the public
meeting or submitted to the related docket. This concept paper contains:

8 See http://www.fda.gov/ohrms/dockets/ac/03/slides/4007s1.htm.
9 See http://www.fda.gov/ohrms/dockets/ FDA-2008-N-0281.
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(1) A summary of plans and logistics to date on the proposed pilot program
(2) Recommendations, based on FDA's current review processes, on how applicants who
choose to participate in the pilot program can assess a proposed proprietary name for
safety (i.e., potential for medication errors) and provide that information to FDA.
(3) Recommendations on how pilot participants, may also, at their option, assess and
provide information regarding promotional implications of the proposed proprietary
name.
(4) A discussion of how the Agency will evaluate the pilot project submissions
Some general information on data sources is provided in the Appendix.

III.

PDUFA PILOT PROGRAM—LOGISTICS

As outlined above, one of FDA’s performance goals under PDUFA IV is to develop and
implement a pilot program that would enable participating pharmaceutical firms to evaluate
proposed proprietary names and submit the data generated from those evaluations to the FDA for
review. Using best practices when carrying out their own proprietary name reviews and
providing FDA with the resulting data may help ensure that pharmaceutical firms are able to
choose appropriate proprietary names for their products before submitting their applications
(e.g., not misleading or likely to lead to medication errors), thus making FDA's application
review more efficient and transparent and reducing the likelihood of rejection.
FDA intends the following general plans for the pilot project.
A.

What Are the General Logistics of the Pilot Program?

Although procedures for registration for participation in the pilot program are still being
developed, FDA expects that enrollment in the pilot program for proprietary name analysis will
begin by the end of FY 2009 (September 30, 2009). Participation in the pilot program will be
voluntary for applicants, though the FDA expects that many applicants will be interested in
participating. To help manage workload, as described below, applicants will be asked contact
FDA and register before making their proprietary name submissions. Notice of the procedures
will be published and a date for registration to begin will be established.
The FDA hopes that during the two-year enrollment period, 25 to 50 proposed proprietary name
submissions will be received and reviewed under the pilot program. To achieve this goal and
manage workload within the PDUFA IV timelines, the FDA plans to accept on average one or
two submissions per month. The FDA will strive to include a cross-section of applicants that
represent large, medium, and small companies. We recognize that some companies may contract
this work out to third party vendors. We welcome these submissions. As FDA does not control
the selection of these vendors, the pilot program has no mechanism to ensure a wide number of

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vendors will be represented in this program. The FDA expects that enrollment will last for two
years, after which the FDA will evaluate the pilot program.
For applicants not participating in the pilot program, proposed name submissions will be
analyzed and evaluated using FDA’s traditional approach to the review of proposed proprietary
names.
B.

How Will the Pilot Program Function?

Applicants can submit a proprietary name analysis to the FDA (i.e., CDER or CBER) either
during the investigational new drug application (IND) process, or as part of the initial submission
of the NDA, BLA, or ANDA. Submissions during the IND phase will be accepted only for
products that have completed phase 2 of clinical development.
As soon as an applicant has determined that it would like to participate in the pilot program and
has selected a specific proprietary name that it desires to evaluate and submit, the applicant
should contact FDA to register and indicate the approximate date of the intended submission.
This will enable FDA to manage workflow under the pilot program. . Applicants should then
contact the appropriate center 120 days prior to the intended date of the proposed proprietary
name submission to discuss specific details of the planned submission.
Applicants can communicate with FDA’s project managers regarding questions about their
proposed submissions. If necessary, the applicants will be asked to submit their questions in
writing; in some cases, a face-to-face meeting to discuss the planned submission may be
appropriate.
C.

What If I want to Deviate from the Process in the Concept Paper?

Although participation in the pilot program is entirely voluntary, all pilot participants are
expected to provide information evaluating the safety (potential for medication error) presented
by their proposed proprietary name. Applicants can still participate in the pilot program if they
plan to deviate from the proposed proprietary name safety evaluation process outlined in this
concept paper and instead use additional or alternative methods. Applicants can also participate
in the pilot program without submitting any information to evaluate the promotional implications
of their proposed proprietary names (see section IV.B). However, the pilot program will not
accept applications that include only an evaluation of the promotional implications of a proposed
proprietary name.
For prescription products, applicants should inform the appropriate center at the 120-day presubmission discussion (recommended above) if they plan to use alternative or additional methods
to evaluate the safety of their proposed proprietary name. However, the FDA does not have the
resources and, therefore, does not intend to review proposed alternative methodologies with the
intent of coming to agreement with an applicant on the appropriateness of these alternative
methodologies prior to submission. In such cases, the FDA’s review of the alternative
methodologies will occur during the review of the actual submission. Consideration will be

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given to the strengths and limitations of the alternative method(s) in addition to assessing the
adequacy of the data submitted in support of the proposed alternative.
For nonprescription products, FDA encourages sponsors to discuss with the Agency different
protocols that could be used for their specific products prior to submission of the proprietary
name (see section IV.A.8).
D.

Why Do I Have to Make Two Submissions?

For purposes of the pilot program, applicants will be asked to submit two separate sets of drug
name-related information to enable the FDA to conduct parallel reviews. The first set should
include the applicant’s comprehensive evaluation of the proposed proprietary name as described
in Section IV of this paper (a recommended template has been provided in Attachment B). The
second submission should include the information applicants submit under the Agency's current
practice. 10 These two sets of materials will enable FDA to perform two separate, independent
reviews in parallel and compare the results as described below.
The first review will evaluate an applicant’s proprietary name using the data submitted by the
applicant obtained from the test methods outlined in this paper. The second review will
independently analyze the proposed proprietary name using the FDA’s traditional approach to
review of proposed proprietary names. The two reviews will be conducted by two different
reviewers, who will not share with each other any details of the data or other findings during the
review process. At the end of the review process (i.e., when each reviewer has come to a
conclusion regarding the acceptability of the proposed proprietary name), the two reviewers,
along with other FDA experts in proprietary name review, will meet to discuss the data and their
conclusions. At that time, the two reviewers will note any differences in the data, findings, and
conclusions between the two analyses and reviews. Discussion will focus both on the
differences in the outcomes of specific analyses, as well as on differences in the overall
conclusion regarding the acceptability of the proposed proprietary name. The FDA will exercise
its scientific judgment in determining the overall acceptability of the proposed name based on all
available data. All noted differences in the specific analyses and conclusions will be shared with
the applicant once a final decision has been made.
E.

What Happens To My Submission and How Will It Be Reviewed?

Once the FDA receives a proprietary name submission under the pilot program, it will determine
if the submission contains the comprehensive information essential for evaluation of the
proposed name. A comprehensive submission is one that contains:
•
•

At least one proposed proprietary name
Identification of the first-choice proprietary name, if more than one name is submitted

10 FDA is developing guidance on the contents of a complete submission for the evaluation of proprietary names, to address the
materials recommended to support review under its current approach.
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•
•

Data-driven analyses of the acceptability of the proposed proprietary name, including a
clear description of the methods, the data sources, and the raw data
Information needed to evaluate the proprietary name under the traditional review process
(i.e., proposed name, product profile, labels, and labeling)

The FDA will encourage applicants to submit proprietary name evaluations based on the
methods set forth in the concept paper. However, an applicant’s completion and submission of
these evaluations is not necessary for the FDA to consider a submission complete. Applicants
can submit alternative evaluations. If, on their face, these evaluations are data-driven, the FDA
will accept the submissions. Review of the alternative methodologies will occur during the
review of the actual submission.
If the FDA determines that a submission of a proprietary name evaluation is incomplete, it will
inform the applicant promptly.
F.

Will IND and NDA/BLA Submissions Be Handled Differently?

When the FDA receives a submission of a proposed proprietary name evaluation under the pilot
program during the IND phase, it will aim to complete its two independent reviews and arrive at
a decision within the review performance goal timelines stipulated under PDUFA IV (180 days
from receipt of complete submission, i.e., submission of information needed to evaluate the
proprietary name, in 50 percent of cases in FY 2009 and 180 days in 70 percent of cases in FY
2010). When the FDA receives a submission of a proposed proprietary name evaluation under
the pilot program at the time an NDA or BLA is submitted, it will aim to complete its two
independent reviews and arrive at a regulatory decision within the review performance goal
timelines stipulated in PDUFA IV (90 days in 50 percent of cases in FY 2009 and 90 days in 70
percent of cases in FY 2010). Proprietary names submitted as part of an ANDA are not subject
to the performance goals stipulated in PDUFA IV, but will be reviewed with a goal of 180 days.
G.

What Will the Agency Review in Determining a Proposed Name's Acceptability?

Once the FDA determines that a submission of a proprietary name evaluation contains the
comprehensive information essential for substantive review, the parallel reviews will begin. The
FDA will assess and review the adequacy of the data from the applicant’s analysis and from the
FDA’s independent analysis. A regulatory decision on the acceptability of a proposed
proprietary name will be based on review of all available data (i.e., the applicant’s evaluation and
FDA’s independent analysis). In addition, the FDA will use the data to evaluate the overall pilot
program.
H.

What If My First Choice Name is Not Acceptable?

Under the pilot program, the FDA will continue its long-standing practice of reviewing the firstchoice name. If the FDA determines that the first-choice name is acceptable, the FDA will not
review the second-choice name. If the FDA determines that the first-choice name is not

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acceptable, the proprietary name review clock established under the goals letter 11 will be
stopped. At that time, the FDA will notify the applicant, in writing, of its decision regarding lack
of acceptability of the proposed first-choice name. The proprietary name review clock will not
re-start until the applicant either has informed the FDA, in writing, that it would like its
originally submitted second-choice name reviewed, or until FDA receives an applicant's
submission of an alternative second-choice name along with the comprehensive information
described below in section III F. At that time, the FDA will begin review of the second-choice
name. In the latter scenario, if an applicant has submitted a complete proprietary name analysis
for the second-choice name, the responsible center will use discretion to determine whether to
review the applicant’s analysis in addition to conducting its own analysis using the traditional
approach. Although the FDA would ideally review the applicant’s completed proprietary name
analysis for the second-choice name, factors such as staffing and timelines will be used in
making this determination.
I.

When and How Will the Pilot Program Be Assessed?

At the end of FY 2011, or subsequent to accruing two years of experience with pilot program
submissions, the FDA will evaluate the pilot program to determine whether to have applicants
perform their own name analysis and submit resulting data to FDA for review. The FDA
anticipates that evaluation of the program will focus primarily on a comparison of the
conclusions the FDA has reached after review of applicants’ analyses of proposed proprietary
names to those the FDA reaches after its own analyses. In addition, the FDA intends to examine
patterns, if any, of differences between its analyses and those performed by applicants and
between its interpretation of the results of specific applicant analyses, applicants’ interpretations
of the same results, and the ultimate regulatory decision that was made. The FDA expects that
these evaluations will be largely qualitative. Any quantitative evaluations will be descriptive.
The results of this pilot program and recommended additions and changes to methods based on
the reported results will be discussed in a future public meeting. Following this meeting, draft
guidance will be published describing the best test methods for proprietary name evaluation.

IV.

ASSESSING PROPOSED PROPRIETARY NAMES IN PILOT PROGRAM

In the following sections, proposals and recommendations about how to assess proprietary names
reflect the Agency's thinking and processes as currently practiced. The goals in Section IV are
two fold: (1) explain and clarify what the Agency's current assessment involves and (2)
recommend approaches pharmaceutical manufacturers should use when performing their
assessments under the pilot program.

11 See section IX.A. of the goals letter, establishing review performance goals for proprietary names. This proprietary name
review clock is distinct from the review performance goal clock for the underlying NDA/BLA submission, addressed in
section I.A. of the goals letter.
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FDA review of proprietary names includes consideration of both safety and promotional aspects.
FDA’s primary consideration when evaluating the acceptability of a proposed proprietary name
is avoiding the risk of medication errors. This safety review is based on the findings of a Failure
Modes and Effects Analysis (FMEA) of the proprietary name. In its safety review, FDA not
only considers the potential for a name to be spelled similarly and/or sound similar to the name
of a currently marketed product or one that is in the approval pipeline, but also considers the
potential for the proposed name to inadvertently function as a source of error for other reasons,
such as by suggesting a dosage form or route of administration. Consideration is given to the
proposed product's characteristics (including its intended use, dosage form, strength, and route of
administration) because the product characteristics provide a context for communication of the
product name and ultimately determine the use of the product in the usual clinical practice
setting. FDA believes that no single test is sufficient to reach a conclusion that a proprietary
name is acceptable. FDA emphasizes that the best approach has proved to be the use of a
combination of tests to evaluate name appropriateness.
The promotional review of proposed names considers whether the name functions to overstate
the efficacy, minimize the risk, broaden the indication, or make unsubstantiated superiority
claims for the product, or is overly “fanciful" by misleadingly implying unique effectiveness or
composition . (See 21 U.S.C §§ 321(n), 352(a) & (n); see also 21 CFR §§ 201.10 (c)(3),
202.1(e)(5)(i) &(e)(6)(i).).
The following sections provide a more detailed snapshot of the Agency's proprietary name
review. Please note that the promotional assessment of a proposed proprietary name as
described in this paper will be optional for applicants participating in the pilot program. If
applicants choose not to participate in the promotional review component of the pilot program,
the Agency will conduct the promotional review using its traditional approach.
A.

Safety Review

FDA’s safety review of a proprietary name involves methods that generate a list of names that
could be confused with the proposed proprietary name as well as methods to test the likelihood
of confusion between these names and the proposed proprietary names.
1.

Preliminary Screening

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Names often fail FDA’s screening process for readily identifiable reasons. Box 1 lists four
naming characteristics that when incorporated into a proprietary name, may cause or contribute
to medication errors. If a proposed name fails the preliminary screening, it is unlikely to be a
viable candidate for a proprietary name. FDA recommends that applicants carefully consider the
factors listed in Box 1 in conducting a preliminary screening of their proprietary name for
acceptability prior to testing.
Box 1: Naming Characteristics Known to Cause or Contribute to Medication Errors
Dosing Interval
The FDA discourages proprietary names that incorporate or suggest a dosing interval (e.g., NameBID). Drug
product characteristics and/or drug release characteristics are subject to change over time with approval of new
dosing intervals, thus possibly rendering the original proprietary name misleading.
Dosage Form/Routes of Administration
Generally, the FDA discourages the use of proprietary names that incorporate or suggest a particular dosage
form (e.g., Nametabs, Namecaps) or route of administration (e.g., Nameoral). Avoiding the suggestion of a
dosage form or route of administration in the name will enable a company to use the same proprietary name for
future dosage forms of the product without making the proprietary name misleading.
Medical And/Or Product Name Abbreviations
The use of common medical abbreviations and coined abbreviations in a proprietary name may be
misinterpreted and therefore should generally be avoided. Abbreviations commonly used for
prescription communication, especially abbreviations recognized as error-prone and potentially
dangerous by the Institute for Safe Medication Practices
(www.ISMP.org/tools/errorproneabbreviations.pdf) and the National Coordinating Council on
Medication Error Reporting and Prevention (www.nccmerp.org), should be avoided.
Names That Include or Suggest the Composition of the Drug Product
Generally, proprietary names that include or suggest the composition of a drug product may be considered
misleading if the proprietary name includes or suggests the name of one or more, but not all, of its ingredients
(21 CFR 201.6(b)). In addition, a proprietary name would generally be considered misleading if it includes or
suggests the name of an ingredient that is not included in the drug product.

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2.

USAN Stem Search

In its review of drug names, the FDA screens proposed proprietary names against the stem list
created by the United States Adopted Names (USAN) Council. The purpose of the Council is to
serve the health professions in the United States by selecting simple, informative, and unique
nonproprietary names for drugs products. Selections are made by establishing logical
nomenclature classifications based on pharmacological and/or chemical relationships.
The USAN Council (tri-sponsored by the American Medical Association (AMA), the United
States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA))
works closely with the International Nonproprietary Name (INN) Programme of the World
Health Organization (WHO) and various national nomenclature groups to achieve global
standardization and unification of drug nomenclature and related rules with the goal of ensuring
that drug information is communicated accurately and unambiguously.
Because the USAN stems are intended to indicate a pharmacological or chemical trait of a drug,
a single stem will be applicable to multiple drug products. Use of these stems in proprietary
names, even when used consistently with the USAN meaning, can result in multiple similar
proprietary names and proprietary names that are similar to established names, thus increasing
the chance of confusion among those drugs. To reduce the potential for confusion, USAN stems
should not be incorporated into proprietary names, and FDA recommends that applicants screen
potential proprietary names against the USAN stem list, and eliminate those that would
incorporate USAN stems.
In evaluating a potential proprietary name against the USAN stem list, the position of the letters
that compose the USAN stem is important. For example, the letter sequence “Gli-” only
functions as a USAN stem when used as a prefix as defined by the USAN Council. An example
of an unacceptable proprietary name including the USAN stem “Gli-” is “Glidrug.” Conversely,
if the same letter sequence that makes up the USAN stem appears in an alternate position in the
proposed name, it may be acceptable. An example of a proprietary name including the letter
sequence “Gli-” without implicating a confusing use of a USAN stem is “Druggli.” FDA
recommends that all proprietary name submissions made under the pilot include a statement
indicating that the name does not contain a USAN stem of any size (e.g., does not contain the
letter sequence in the position designated as a stem by USAN) and the date on which this
information was searched on the USAN list.
3.

Orthographic and Phonological Similarities

When reviewing a proposed proprietary name, the centers consider the spelling of the name,
pronunciation of the name when spoken, and appearance of the name when scripted throughout
the medication use system (e.g., prescribing, dispensing, administering). The staff compare the
spelling of the proposed proprietary name with the proprietary and established names of existing
and proposed drug products because similarly spelled names may have greater likelihood to
sound similar to one another when spoken, or look similar to one another when scripted.

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In addition, the centers will examine the orthographic appearance of the proposed name using a
number of different legible handwriting samples. Handwritten communication of product names
has a long-standing association with product name confusion, often leading to medication errors.
The centers apply expertise gained from root-cause analysis of such medication errors to identify
sources of ambiguity within the name that could be introduced when scripting (e.g., “T” may
look like “F,” lower case "a" looks like a lower case "u," a capital “A” may look like “Ci” or
“Cl”, a lowercase “en” may look like “ar”, “in”, or “ea”), along with other orthographic
attributes that determine the overall appearance of the product name when scripted (see detail in
Table 1 below). Additionally, since spoken communication of medication names is common in
clinical settings, the centers compare the pronunciation of the proposed proprietary name with
the pronunciation of other product names, accounting for the potential for phonological error due
to predictable phonological variance.
The majority of names with similarity to the proposed proprietary name can be identified through
database searches. A variety of publicly available databases and resources containing product
names can be used to identify similar names. The FDA uses such databases, the Internet, and
other printed and electronic drug product resources to search for orthographic and phonological
name similarities.
The FDA proposes that applicants also conduct an extensive search to identify any existing
names that are similar to the proposed proprietary name or names with orthographic and
phonological similarity to the proposed proprietary name. The examples in Table 1 should be
useful in this search. It is recommended that applicants search a variety of sources and, at a
minimum, search the publicly available databases listed in Appendix A. We recognize that
applicants do not have access to proposed proprietary names that are in the FDA review pipeline.
Such a limitation will be documented in FDA’s final review.
The FDA proposes that applicants submit the following information with their applications:
•
•
•
•
•
•

All search queries
The system parameters used for each search (e.g., letter substitution)
The precise databases searched
Any thresholds imposed on the output (e.g., top 100, top 200, etc.)
The date the search was conducted or the last update of the database that was searched
Pooled results with source citation and full product characteristics of each name identified as
a possible source of confusion with the proposed name.

Note: Although such searches generate many names that may be ruled out under further
analysis, we request that applicants submit all names originally identified as potentially similar to
the proposed name.

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Table 1:
Criteria Used to Identify Product Names that Look or Sound Similar to a
Proposed Proprietary Name
Type of
similarity

Potential causes of
product name
similarity
Similar spelling

Look-alike

Orthographic
similarity

Sound-alike

4.

Phonological
similarity

Considerations when searching the databases
Attributes examined to
Potential Effects
identify similar product
names
Identical prefix
Names may appear similar in
Identical infix
print or electronic media and lead
Identical suffix
to product name confusion in
Length of the name
printed or electronic
Overlapping product
communication
characteristics
Names may look similar when
scripted and lead to product name
confusion in written
communication
Similar spelling
Names may look similar when
Length of the name
scripted, and lead to product
Upstrokes
name confusion in written
Downstrokes
communication
Cross-stokes
Dotted letters
Ambiguity introduced by
scripting letters
Overlapping product
characteristics
Identical prefix
Names may sound similar when
Identical infix
pronounced and lead to product
Identical suffix
name confusion in spoken
Number of syllables
communication
Stresses
Placement of vowel sounds
Placement of consonant
sounds
Overlapping product
characteristics

Computational Methods

To complement the above-delineated process, FDA may use a computerized method to identify
any phonological and orthographic similarities between product names. FDA recommends that
applicants use such a program. Although these computerized methods are useful in hypothesis
generation (i.e., developing the list of possible names that could be confused with the name
under review), they should not be used for the more complex task of hypothesis testing (i.e.,
evaluating which names have potential for error and harm). No single method can evaluate all
dimensions of similarity, nor will any single measure perform as well an intelligently assembled
combination of measures (e.g., one that integrates measures of orthographic, phonological, and
semantic similarities).

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There are reasons why computerized methods and algorithms are not useful for hypothesis
testing. First, programs that use String-edit distance and Bigram pairs do not fully evaluate the
similarity of names, particularly with respect to orthographic appearance. Predictions based on
computerized measures of similarity will occasionally yield both false positive predictions (i.e.,
saying a pair is confusing when it is not) and false negative predictions (i.e., saying a pair is not
confusing when it really is).
Although the computerized methods and algorithms provide reproducible measures of similarity
or dissimilarity, these measures are difficult to interpret when the scores reveal moderate
similarities or dissimilarities between the names.
The FDA proposes that applicants use computerized methods and algorithms that can detect the
similarity of product names from a phonological perspective, orthographic perspective, or both.
In submitting computational data, the FDA recommends that applicants provide the following
information:
•
•
•
•
•
•
•

The measure of similarity/distance used
The values assigned to any adjustable parameters
The manner in which non-name attributes (e.g., strength, dosage form, route of
administration) were handled
If a weighting scheme was used, describe how the different elements were weighted
The precise database searched (e.g., Orange Book, including or excluding discontinued
products, USPTO (what class), Multum Lexicon).
If a cutoff or threshold was used to narrow or widen the search results, the cutoff or
threshold, and how and why it was chosen
Testing output
5.

Medication Error Data

FDA believes that data obtained from case reports of medication errors help to inform the
analysis of a proposed proprietary name and overall product design (e.g., packaging, labels, and
labeling). The FDA searches databases containing medication error reports with the goal of
identifying relevant information about potential errors before approval.
FDA recommends that when a proposed product contains an active ingredient that is marketed
domestically or abroad, all available information relevant to medication error cases associated with
that active ingredient be identified and submitted to the FDA. Applicants can obtain medication
error report information from their own safety databases. Medication error report data also can be
obtained from published literature, and any other relevant databases (e.g., data collected by other
regulatory authorities as set forth in Appendix A).
Relevant information would include any error reports related to the product nomenclature
(established and proposed proprietary name), product design, label, and labeling. This
information should be identified and reported to the FDA in line listings with a narrative as
described in Box 2.

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Box 2: Format for Submitting Relevant Information
•
•
•
•
•

The FDA recommends that applicants submit a line listing and narratives of the medication error
case reports identified in the postmarket period for marketed products with the same active
ingredient as the product under review.
The applicant should cite the source of the report along with any analysis conducted by the
applicant.
Applicants should submit the full text of any article published on medication errors associated
with the product.
Applicants should also categorize these errors by type (e.g., incorrect product, incorrect route of
administration) using the NCC MERP taxonomy.
Applicants should review these cases to identify factors that contributed to the medication errors
and to ascertain whether these risks apply to the proposed proprietary product name. All
medication error data should be integrated into the FMEA.

6.

Name Simulation Studies

FDA performs limited internal simulation studies to test the response of healthcare practitioners
to proposed names. FDA believes that applicants should consider the following elements when
planning the use of simulation studies.
a.

General description

Generally, name simulation studies test the response of practitioners to a proposed name by
asking them to use the name in simulated real-world conditions. The more closely the simulation
approximates real use conditions, the more valuable the simulation. At a minimum, certain
characteristics of real use conditions are easily simulated and should be present (e.g. in the use of
lined paper, prescription pads, and telephone orders to approximate inpatient written, outpatient
written and outpatient verbal prescribing, respectively, and the use of background noise, different
handwriting samples, different color inks, directions for use, and different voices/accents to
mimic the diverse prescribing conditions). Additionally, the simulation study should present the
name with the corresponding product characteristics (e.g., strength, route, dosing, and frequency)
that are likely to be used to communicate prescriptions and orders for the proposed product.
b.

Study design

A simulation study designed to detect close to a zero percentage error rate with statistical
significance would require an extremely large sample size (e.g., a sample of ~26,000 would be

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required to detect an error rate of 0.001 at the 0.05 significance level ). We recognize that a
study of this magnitude is not realistic. However, we may be able to understand how a proposed
name might perform in real world conditions through a well-designed parallel group
observational study. In such a study, each group represents different prescribing scenarios based
on all of the potential prescribing conditions for the proposed product (e.g., for an inpatient
written order, an order written by a physician using lined paper, transcribed and entered into a
computer by a unit clerk, read and dispensed by a pharmacist, read and administered by a nurse).
When performing simulation testing, both quantitative and qualitative data should be collected.
Both types of data can be collected anywhere in the medication use system. For example,
quantitative data might document how many times a participant interpreted a prescription
correctly and how many times it was misinterpreted. The qualitative data would include any
concerns or problems the participants thought of or encountered while going through the process
(e.g., no error occurred but a participant felt that there could have been an error in a different
situation).
c.

Participants

All participants in name simulation studies should be active practitioners, such as prescribers,
transcribers, dispensers, or administrators of drugs in the proposed prescribing condition for the
product, and should be representative of the full range of persons involved, including physicians,
physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, ward clerks,
and other relevant individuals.. All settings (e.g., community pharmacy, ambulatory care,
hospital, long-term care) where the product could be used should be considered. For example, if
a product will be prescribed by private practice oncologists, the participants should include, but
not be limited to, private practice oncologists, nurses working in this private practice setting, and
other individuals who might call in a prescription from this setting. If the product will be
dispensed in an inpatient setting, the participants should include, but not be limited to, inpatient
pharmacists, pharmacy technicians, ward clerks and nurses. Consideration should be given to
including primary care practitioners, pharmacists, and nurses even when evaluating names of
specialty drugs to probe what medication names outside the specialty might cause error. These
stakeholders will bring experience from different workflow and practice environments.
Patients should be included in Failure Mode and Effects Analysis for all products (see section 7).
However, the FDA does not generally consider it necessary to include patients in a name
simulation study for a prescription product that is simulating use in an inpatient setting because
patients are not involved in the prescribing, dispensing, and administration of medications in this
setting of care.

12 This calculation was made to determine whether the error rate differs from 0.001 at a 0.05 significance level and

80% power, assuming the medication error rate of the sample is 0.0005.
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d.

Number of scenarios

The FDA recommends that a minimum of 20 scenarios representing each possible prescribing
condition for the proposed drug be performed to provide an adequate descriptive assessment
(e.g., communication from physician to ward clerk to pharmacist to nurse). Participants involved
in a name simulation study can participate in the testing of an unlimited number of proposed
proprietary names. However, to minimize bias, a name should not be tested by the same
participant more than once. The number of participants in each simulation scenario should reflect
the actual number of participants in an actual clinical scenario. Generally, these scenarios will
involve 2 to 5 participants (e.g., physician—ward clerk—pharmacist—nurse). Table 2 provides
20 scenarios that could be used for an inpatient setting. We estimate that approximately 70
participants will be needed because not all scenarios will involve the same number of
participants (e.g., physician—pharmacist).
Each possible prescribing condition for the proposed drug should be tested several times giving
consideration to all modes of communication (e.g., spoken, written, computer order entry,
computer selection and selection of drug from drop down menu) (see examples Table 2 below).
For example, for a drug that is administered only intravenously in an inpatient setting, an
outpatient simulation using a handwritten prescription may not be helpful because this product
would not be typically used in this setting of care. A simulation for an orally administered drug
that could be dispensed in both in- and outpatient settings should contain all possible inpatient
and outpatient scenarios. Table 2 shows example scenarios for an orally administered drug.
These example scenarios should be revised to reflect the likely setting(s) of care for the product
and be specific to how the applicant’s product will be prescribed, transcribed, dispensed, and
administered in the real-world condition.
Applicants should consider embedding the test name in a list of two or three other test names of
marketed drugs in the simulated prescriptions, or consider other simulated prescription formats
that are designed to mimic the results of real-world settings. Spoken orders should include
several scenarios with an unaided pronunciation and several scenarios with a pronunciation
based on how the applicant proposes to pronounce the name when marketed (e.g., “Kaletra” is
pronounced by some as Kuh-let-ra and the applicant’s pronunciation is Kuh-lee-tra).
Table 2:
Example Scenarios for Name Simulation Study for an Orally Administered Drug
Scenario
Prescribing Condition
Participant Group
Number
1
Inpatient: Written order on lined paper
physician A - ward clerk A – nurse A pharmacist A - nurse B
2
Inpatient: Written order on lined paper
physician assistant A - ward clerk B – nurse C
- pharmacist B – nurse D
3
Inpatient: Written order on lined paper
physician B – nurse E – pharmacist C – nurse F
4
Inpatient: Written order on lined paper
physician C - ward clerk C – nurse G pharmacist D – nurse H
5
Inpatient: Spoken order transcribed to a
physician D – nurse I - ward clerk D –
written order unaided pronunciation
pharmacist E – nurse J

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Table 2:
Example Scenarios for Name Simulation Study for an Orally Administered Drug
Scenario
Prescribing Condition
Participant Group
Number
6
Inpatient: Spoken order transcribed to a
physician assistant B – nurse K - ward clerk E
written order unaided pronunciation
– pharmacist F – nurse L
7
Inpatient: Spoken order transcribed to a
physician E – nurse M – pharmacist G – nurse
written order pronunciation as intended by
N
applicant
8
Inpatient: Spoken order transcribed to a
physician F – nurse O - ward clerk F –
written order pronunciation as intended by
pharmacist H – nurse P
applicant
9
Inpatient: Direct computer entry
physician G - pharmacist I - nurse Q
10
Inpatient: Direct computer entry
physician assistant C - pharmacist J - nurse R
11
Inpatient: Direct computer entry
physician H - pharmacist K - nurse S
12
Inpatient: Direct computer entry
nurse practitioner A - pharmacist L - nurse P
13
Outpatient: Written prescription
nurse practitioner B - pharmacist M
14
Outpatient: Written prescription
physician I - pharmacist N
15
Outpatient: Written prescription
physician J - pharmacist O
16
Outpatient: Written prescription
physician assistant D - pharmacist P
17
Outpatient: Spoken prescription left on
nurse practitioner C - pharmacist Q
voice mail unaided pronunciation
18
Outpatient: Spoken prescription left on
physician K - pharmacist R
voice mail unaided pronunciation
19
Outpatient: Spoken prescription left on
nurse practitioner D - pharmacist S
voice mail pronunciation as intended by
applicant
20
Outpatient: Spoken prescription left on
nurse practitioner E – pharmacist T
voice mail pronunciation as intended by
applicant
21
Outpatient: Electronic generated
physician L – pharmacist U
prescription
22
Outpatient: Electronic generated
physician M – pharmacy technician A –
prescription
pharmacist V
23
Outpatient: Electronic generated
physician assistant E – pharmacist W
prescription
Total Participants 70

Each participant should be interviewed at the end of the simulation using nonleading scripted
follow-up questions. Responses should be recorded verbatim. All qualitative data derived from
follow-up questioning should be coded and analyzed based on verbatim responses from the
participants (Table 3). When the results are submitted to FDA for review, the raw data should
include the coded responses as well as all the verbatim data.

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Table 3:
Examples of Coded Responses to Follow-up Questions
Follow-up Questions
Coded responses
Participants with
coded response
Do you think this name looks like
Yes
8
any other drug name?
No
52
If yes which drug?
Brand X
3
Brand Y
5

Do you think this name sounds like
any other drug name?
If yes, which drug?

Yes
No
Brand X

8
52
8

Do you think this name looks like
any medical terms or laboratory
tests?
If yes, what terms or tests?

Yes
No

0
60

Do you think this name sounds like
any medical terms or laboratory
tests?
If yes, what terms or tests?

Yes
No

0
60

Describe your overall impression of
the name. These comments do not
necessarily have to be related to
safety.

There are many drug names on
the market that seem to start
with ___.
Good name does not appear to
be a problem
The name seems to conflict with
what the drug is suppose to treat

12

35
13

Transparency of the study process is essential. Applicants should submit, and the FDA will
review, all methodology associated with the simulation study—including but not limited to how
participants were chosen and the composition and qualifications (e.g., current roles in clinical
practice) of participants.
7.

Failure Mode and Effects Analysis

Failure Mode and Effects Analysis (FMEA) is a systematic prospective method the FDA uses to
examine the nomenclature, labeling, and packaging for possible ways in which a failure (i.e., an

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error) can occur. 13 Postmarket experience has shown that the nomenclature and design of the
label/labeling and packaging of a product directly contributes to the occurrence and the
likelihood of medication errors.
FMEA capitalizes on the predictable and preventable nature of medication errors and enables the
identification of failure modes prior to approval, when actions to overcome these issues are
easier to implement than remedies available in the postapproval phase. When performing a
FMEA of a proposed product, the FDA considers the use of the product at all points in the
medication system. Applicants should do the same. Because the proposed product is not yet
marketed, the applicant should anticipate the use of the product under the proposed prescribing
conditions by considering the intended indication and product characteristics. The applicant
should then consider the proposed product in the context of the usual practice setting and work to
identify potential failure modes and the effects associated with the failure modes.
a.

Identifying failure modes

To identify potential failure modes, the applicant should compare the proposed proprietary name
to all of the names gathered during the safety review. The applicant should consider the
vulnerability of the proposed name to misinterpretation and confusion and ask the following
questions:
•

Could the similarity of this proposed proprietary name to other proprietary names cause
the names to be confused with one another at any point under the proposed prescribing
conditions? As a guide to answering this question, one should consider the similarity or
dissimilarity of the names in question in their entireties as to spelling, appearance, sound,
connotation, and commercial impression.
Are there other aspects of the proposed proprietary name, unrelated to the orthographic
and phonological similarity that could be potentially misleading and cause confusion at
any point under the proposed prescribing conditions? Such errors may not necessarily
involve confusion between the proposed drug and another drug product. For example, the
FDA has learned that a proposed name for a multi-ingredient product that represents only
one of the active ingredients contained in the product 14 ; names that may encode a
frequency or route of administration inconsistent with the actual product characteristics; or
names that look or sound like other medical terms, diagnostic tests, and abbreviations are
name characteristics that could cause confusion and lead to medication errors.

An applicant should support a “no” answer to either or both of these questions by providing FDA
with its raw data and a summary of the basis for its conclusion that the name is not confusingly
similar to any other names or will not otherwise cause medication error; however, for a “no”
answer, the applicant need not go on to conduct the analysis described in next section of this

13 Joint Commission Resources, Root Cause Analysis in Healthcare 201 (3d ed, 2005).
14 See 21 CFR 201.6(b), establishing that labeling may be misleading if the name of the drug includes or suggests the name of
one or more but not all of its ingredients.
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paper. A response of “yes” to either of the above questions indicates a failure mode and
represents the potential for a proposed proprietary name to lead to confusion and
misinterpretation. In the case of a “yes” answer, the applicant should proceed to conduct the
evaluation described in the following section.
b.

Identifying failure effects

If the answers to the either of the aforementioned questions is “yes,” the next step in the FMEA
is to evaluate all potential failure modes. The potential failure modes are evaluated to determine
the likely effect of the confusion, by asking the following question:
•

Could this confusion result in medication errors in the usual practice setting?

The answer to this question is a central component of the FDA’s overall risk assessment of the
proposed proprietary name. If the FMEA determines that the source of confusion is unlikely to
ultimately cause medication errors under the proposed prescribing conditions, the proposed name
and findings should be submitted to the FDA for further review.
If the FMEA determines that the proposed proprietary name could be a source of confusion that
could cause medication errors under the proposed prescribing conditions, an alternate proprietary
name should be evaluated.
In certain instances, the FMEA findings may suggest other risk-reduction strategies, such as
product reformulation to avoid an overlap in strength or an alternate modifier designation that
may reduce the risk of medication errors resulting from product name confusion. Alternatively,
the applicant may try to justify why the finding might not lead to a medication error or why the
risk of medication error with the proposed name is less than risks associated with other
alternative nomenclature options.
c.

FMEA team

Selection of the FMEA team is a critical step in the FMEA process. The team should be
multidisciplinary to ensure that different perspectives and viewpoints are brought to the process.
The team should include a representative sample of practicing health professionals of varying
clinical backgrounds, disciplines, and experience who would be procuring, prescribing,
dispensing, and administering the product under evaluation as described in Section IV.A.6.c.
above. If a product will be dispensed in an outpatient setting, the team should also include a
patient. The FMEA team should include health professionals with experience in actual-use
settings and members with expertise in the field of medication error prevention. FMEA teams
typically consist of 8 to 12 members. 15

15 Joint Commission on Accreditation of Healthcare Organizations, Failure Mode and Effects Analysis in Health
Care: Proactive Risk Reduction 27 (2005).

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The FDA will review the methodology associated with the FMEA including how the team was
chosen, the composition of the team and qualifications (e.g., current roles in clinical practice) of
its members, the failure modes identified, and any proposed risk mitigation strategies.
The step-by-step FMEA analysis, conclusions, and rationale should be submitted to the FDA as
part of any proposed proprietary name submission under the pilot program.
8.

Nonprescription Drug Products Analysis

The proposed proprietary names of nonprescription drug products (also known as over-thecounter (OTC) drugs) submitted for approval under an NDA or ANDA are assessed prior to
approval of the drug, as part of the review of the complete product labeling (see 21 CFR
314.125(b)). Consumer safety issues are given particular consideration in the labeling
evaluation of these products. Under the pilot program, OTC product names should be assessed
using the methods described in Sections 1-7 above, taking into account the following
considerations.
y OTC drugs are routinely selected and purchased by consumers and often recommended
by name to consumers by a healthcare practitioner. For these reasons, names for OTC
drugs should be evaluated using simulation studies designed to test both consumer and
healthcare professional understanding of proposed proprietary names. It may be
important to evaluate whether participants can interpret written and oral communication
of the name to safely select the proposed product.
y FDA regulations (21 CFR 201.60, 201.61 and 201.62) outline the type of information
that is required on the principal display panel of an OTC drug product. This information
is important so the consumer can accurately self select and use the product, and as such,
should not be misleading.
y Although some packages may adhere to these regulations regarding the content of the
principal display panel, in addition to the proprietary name, the presentation of
information on the package may be inadequate and lead to consumer confusion,
resulting in medication errors.
y Concerns include, but are not limited to: information may be presented in a confusing
manner; the package may lack necessary information for proper use; or there may be a
failure to present the information so a consumer can differentiate the product from other
similar products and use it correctly.
y When a proprietary name is the name of a family of products, with multiple product
names differing only by the suffix, it is even more important that the information on the
principal display panel enable the consumer to differentiate products at the point of
purchase. Even distinguishing information elsewhere on the outer carton labeling may
be overlooked.
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y There are a number of examples to illustrate potential problems. Companies have used
the same proprietary name for single ingredient and combination products containing
different active ingredients, or the same name for different combinations, causing
consumers to purchase the wrong product.
y FDA is also aware of consumer confusion resulting from the use of proprietary names
that differ only by the suffix attached to them to designate a variety of combination
drug products, containing up to four ingredients (e.g., OURDRUG PM, OURDRUG.
Cough and Cold formula.) When the same proprietary name is used for products
containing different active ingredients, studies should be conducted to determine
whether consumers are able to differentiate these products with the same proprietary
name, with or without a suffix, based on the other information on the principal display
panel.
It is difficult to design a single study that could address all possible scenarios. Thus, FDA
encourages sponsors to meet with the Agency to discuss different protocols that could be used
for their specific products prior to submission of the proposed proprietary name. We recognize
that the design of the studies may need to differ depending on the issues affecting a proposed
product.
The following general principles should be applied when testing a proprietary name of an OTC
drug product in consumer and healthcare professional populations:

B.

•

The evaluation should assess whether or not a proprietary name exaggerates the safety or
effectiveness of the product or is otherwise confusing or misleading. Aspects to consider
include whether or not a proprietary name implies an indication or use, active
ingredient, dosing frequency, population, route of administration, and duration of effect
that is inconsistent with the proposed dosing frequency, population, route of
administration, and duration of effect of the product.

•

Evaluation questions should be nonleading and filter questions should be incorporated
into the questionnaire (e.g. “Does the name tell you what the product is used for?”, yes
or no. If yes, “what does it tell you it is used for?”)
Promotional Review (Optional)

The FDA evaluates proposed proprietary names to determine if they are overly fanciful, so as to
misleadingly imply unique effectiveness or composition, as well as to assess whether they
contribute to overstatement of product efficacy, minimization of risk, broadening of product
indications, or making of unsubstantiated superiority claims. See 21 U.S.C §§ 321(n), 352(a) &
(n); see also 21 CFR §§ 201.10 (c)(3), 202.1(e)(5)(i) &(e)(6)(i).
1.

Participation in the Promotional Review Element of the Pilot Program

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As previously noted, an applicant who chooses to participate in the pilot program may do so
without submitting information regarding the promotional implications of its proposed
proprietary name; pilot participation requires only the submission of safety review information.
FDA will conduct its customary promotional review whether or not an applicant submits its own
promotional review. Sponsors who choose to participate in the promotional review aspect of the
proprietary name pilot program may do so either (1) as part of an initial proposed proprietary
name submission made under the pilot, or (2) as part of a response to FDA’s rejection of a
proposed proprietary name submitted under the pilot (where the initial submission addressed
only safety review).
2.

Evaluation

If an applicant chooses to conduct a promotional review, the promotional and safety reviews
should be performed independently from one another so as to minimize bias in either review.
The promotional review should focus on avoiding names that overstate product efficacy or
safety, expand product indications, suggest superiority without substantiation, or that are of a
fanciful nature that misleadingly implies unique effectiveness or composition . It would be
desirable for the promotional evaluation to involve personnel from marketing, regulatory affairs,
social scientists with expertise in consumer psychology, and legal staff to determine whether a
proposed proprietary name contains misleading implications. The company’s evaluation team
should include persons versed in the regulations that govern prescription product advertising and
promotion, with experience in the process of reviewing proposed promotional materials and
proposed proprietary names. 16 The analysis of sound empirical data, if available, should be
given prominence in the evaluation of proposed proprietary names.
To increase transparency and predictability in the review of proposed proprietary names from a
promotional perspective, the FDA has proposed a quantitative evaluation method. The design
and methodology of studies used for this evaluation should be valid and reliable. To facilitate
collective evaluation at the end of the pilot program, it would be helpful for these studies also to
use the same measures. Although development of standardized, validated questionnaire
measures (i.e., standard questions to be used across all studies) is thus desirable, it is beyond the
17
scope of this concept paper. One possible study methodology and some sample questions are
included below. These question samples are designed to guide sponsors in the development of
outcome measures in their studies but are not intended to be an exhaustive list. Sponsors are
encouraged, but not required, to seek advisory comments from the Agency on their proposed
study methodology, questionnaire, and analysis plan prior to data collection.
3.

Research Methodology

16 A company’s internal process for selecting among potential names is not intended to be part of the submission. The
company’s submission should address only section B.3. Methodology.
17

Frameworks for designing a study to examine the potential promotional implications of proposed proprietary
names are available. See, for example, Whitley, Jr., B.E. (1996). Principles of research in behavioral science.
Mountain View, CA: Mayfield Publishing Company.
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The FDA recommends an experimental approach to evaluate promotional implications of
proposed names because this method enables interpretation of causal relationships between
variables. That is, by controlling all other experimental factors besides the drug name,
researchers can be confident that the name itself caused particular responses. Box 3 provides one
possible approach for such an evaluation. Other approaches may be appropriate.
The approach described in Box 3 should be especially helpful in gathering information about
how a name influences attitudes and behaviors of practicing healthcare practitioners. If
participants are only asked what they think about the proposed name, it will be difficult to
determine how accurately their responses reflect their actual thoughts or likely behaviors because
participants may state what they think they should state or what they think the investigators want
to hear. By comparing the responses to the proposed name with responses to the neutral control
name, however, it could be determined whether the proposed name actually does influence these
thoughts and intended behaviors.
a.

Design of Questions

A combination of open-ended and closed-ended questions, arranged from more general to more
specific, should be used. Questions should be designed so as to avoid leading questions, yea18
saying and other forms of bias. Initial questions in the study should be asked before
participants have any information about the product so that the answers will not be influenced by
knowledge of product characteristics. Subsequent questions would be asked after receiving
indication information for the product but no other identifying information. Because IND studies
themselves form the basis of ultimate determinations about the efficacy and risk of a drug
product seeking approval, the specifics may not be known at the time the proprietary name is
proposed and undergoing testing. Thus, there should be a measure of participant response when
they have only minimal information.

18 For a brief discussion of questionnaire bias in label comprehension studies, see Morris, L.A., Lechter, K.,

Weintraub, M., and Bowen, D. (1998). Comprehension testing for OTC drug labels: Goals, methods, target
population, and testing environment. Journal of Public Policy and Marketing, 17(1), 86-96.
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Box 3: Possible Evaluation Design
The FDA proposes a crossover design in which the proposed proprietary name is evaluated in the context of both a
neutral control name and an extreme control name. This involves splitting the sample into two groups, both of whom
will evaluate the proposed proprietary name but in a different order from each other.
Before testing the proposed proprietary name, two control names should be established through pretesting:
A neutral control name that is pretested to ensure that it makes no representations at all (i.e., it is neutral from a
promotional standpoint) should be established.
An extreme control name that is pretested to ensure it makes clear misrepresentations should be established
The entire sample will respond first to questions about the neutral control name, described above. Next, half of the
sample responds to the proposed name and then to the extreme control name described above. The other half of the
sample responds to this extreme control name first and then to the proposed name.
The study questions used as outcome measures should cover perceptions elicited by the proposed name that are of a
promotional nature (e.g., product safety, efficacy, indication, superiority), as well as questions designed to elicit
aspects of behavioral intent (e.g., likelihood to prescribe). The comparison of interest is participant responses to the
proposed name compared with responses to the neutral control name. The extreme name serves as a positive control
to ensure that individuals can identify names that make representations about efficacy, safety or other promotional
aspects.
The FDA suggests that the neutral and extreme names be fictitious in nature to control for participants’ prior
experience and attitudes. Existing names could be acceptable as neutral or extreme controls if they are pretested and
shown to possess the desired experimental qualities outlined above.
Sponsors may choose to select different neutral and extreme control names for each study or they may choose to use
the same neutral and extreme control names for multiple studies. Respondents should be exposed to the neutral
control name only once across studies: that is, sponsors that choose to use the same neutral name in more than one
study should choose a new test sample for that study to ensure that participants have not previously responded to the
neutral name.

Examples of questions include:
•

You have just learned of a new product named DRUG X. What, if anything, does the
name DRUG X say or suggest to you about the product? (open-ended question)

•

Based on this name, which of these conditions do you think DRUG X treats? (please
choose the best answer) (closed-ended question)
- Condition 1
- Condition 2
- Condition 3
- Condition 4

•

Based on this name, how effective or ineffective would you say DRUG X is?

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-

Very effective
Somewhat effective
Somewhat ineffective
Very ineffective

•

Based on this name, how safe or unsafe would you say DRUG X is?
- Very safe
- Somewhat safe
- Somewhat unsafe
- Very unsafe

•

Now you learn that the product DRUG X is used to treat CONDITION Y. What does
this name mean to you in this context?

•

Based on this name, how safe or unsafe would you say it is to use DRUG X to treat
CONDITION Y?
- Very safe
- Somewhat safe
- Somewhat unsafe
- Very unsafe

•

Based on this name, how effective or ineffective would you say DRUG X is to treat
CONDITION Y?
- Very effective
- Somewhat effective
- Somewhat ineffective
- Very ineffective

•

•

If DRUG X were available, how likely would you be to prescribe DRUG X for
CONDITION Y?
- Not at all likely
- Somewhat likely
- Moderately likely
- Very likely
On a scale from 1 to 5 where 1 equals Strongly Disagree and 5 equals Strongly Agree,
please indicate your agreement or disagreement with the following statement:
This name makes superiority claims over other products with the same indication.

b.

Sampling

Note: these are general comments. A statistician should be consulted before making definitive
determinations about sample size and sampling design. The size of the sample should be
adequate to detect differences. The sample should represent the relevant prescribing population

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and be generalizable to this population. In addition, applicants should also consider testing a
sample of consumers. Although this group does not have prescribing authority, consumers
should and do participate actively in treatment decisions. The product name may play a role here
through direct-to-consumer (DTC) advertising.
c.

Submission to FDA

Sponsors choosing to participate in the promotional review component of the pilot program
should submit to the appropriate center for evaluation all research methodology used to support a
proposed proprietary name. This includes a description of participant demographics; the product
profile provided to study participants; the complete study questionnaire; the coding scheme used
to analyze open-ended questions; complete study results (both positive and negative), including
results of pretests; and any other information given to the study participants regarding the drug
approval process (e.g., copies of FDA regulations given to study participants).

V.

WHAT WILL FDA CONSIDER WHEN EVALUATING PILOT SUBMISSIONS?

This section describes the kinds of things the FDA will consider as it reviews manufacturers'
submissions as part of the pilot program.
A.

Standards

The ultimate goal of FDA's safety review of a proposed proprietary name is avoiding medication
errors. The FDA will evaluate the safety and promotional implications of a name under the pilot
program using the same methods the Agency currently uses to evaluate proposed proprietary
names. If a proprietary name demonstrates vulnerability to confusion in the testing stage, the
FDA will not recommend its approval for use in the market and will request the applicant
propose an alternate name for evaluation. There is no apparent health benefit from using one
name rather than another. From a public health perspective, then, any preventable risk of
medication error that can be identified prior to drug approval should be addressed by selection of
an alternative name if necessary and sufficient to avoid similar risk.. The FDA will examine
both the process used and the reasoning and conclusions reached in an applicant’s determination
that the name it puts forth is safe, and, if addressed by the applicant, that the name does not have
impermissible promotional implications.
B.

Assessing the Data, Methods, and Evaluation

Under the pilot program, the FDA will assess the adequacy of the data collected and submitted to
support the safety and promotional analysis, including any data derived from alternative
methods. We will also identify medication error safety concerns that will need attention prior to
approval. Because the FDA will also evaluate the safety and promotional aspects of the
proposed name using our traditional proposed drug name review, we intend to evaluate and
document the differences in the data, findings, and conclusions between the center’s and
applicant’s analyses and reviews.
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At the end of the pilot, FDA will evaluate the results to determine if the methods described in
this paper are reliable, if methods should be changed or added, and if the model of industry
conducting reviews, submitting the results to FDA, and FDA reviewing the data would be a
better model than the current model. FDA will present these findings in a public meeting in FY
2013 or before.
As a general guide, we plan to consider the following:
1. Did the applicant screen the proposed name with regard to the common errors listed
previously (Box 1) to ensure acceptability for testing?
2. Did the applicant confirm that the proposed name does not contain a USAN stem; was the
date of the search included?
3. Did the applicant conduct a thorough database search to identify existing similar names,
using, at a minimum, those publicly available databases described in Appendix A? Was the
search methodology adequately described, and were all resulting similar names documented?
4. Did the applicant use appropriate computational methods to identify additional look-alike
and sound-alike names? Were the parameters adequately described?
5. Did the applicant consider all available medication error data related to the proposed
proprietary name (e.g. for products with the same active ingredient marketed domestically or
internationally)?
6. Did the applicant conduct a name simulation study that reflected all relevant real-use
conditions (e.g., inpatient/outpatient, written/spoken)? Were all resulting qualitative and
quantitative data from the simulation provided in addition to a clear description of the testing
protocol? Was the appropriate range of practitioners included in the testing?
7. Was the composition of the FMEA team appropriate with respect to the number of people,
healthcare expertise, and medication error experience? Was the FMEA analysis thorough and
well-structured (e.g., were all relevant failure modes and associated effects identified, did the
analysis consider all potential practice use settings, were product characteristics beyond the
proprietary name considered)?
8. If alternate or additional testing methods were used, were these well described and
documented?
C.

Increasing transparency

Although one objective of the pilot program is to increase transparency of the name evaluation
and FDA review processes, in some cases FDA has access to information that is not publicly
available to applicants. The FDA will communicate with the applicant to the extent permitted
by law to describe the nature of this information. Some examples of situations where FDA may
have information that influences its assessment but was not known to applicants include:
•

Other names are in the review pipeline that, in the Agency’s view, may cause confusion
or possible medication error. Under FDA's regulations, information in an unapproved

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application, including proposed proprietary names, is generally not publicly available
(see 21 CFR §§ 312.130, 314.430, 601.50 & 601.51).
•

FDA is aware of postmarket experience or error risks that the applicant may have
overlooked or to which the applicant did not have access.

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APPENDIX A: COMPUTERIZED RESOURCES
In most cases, the computerized resources listed here are publicly available.
Adverse Events Reporting System (AERS)
AERS is a database application in CDER that contains adverse event reports for approved drug
products and therapeutic biologics. Manufacturers, for example, are required to send adverse
event reports to FDA as specified in FDA regulations, and healthcare professionals and
consumers are encouraged to voluntarily report possible errors to the FDA. The main utility of
such a spontaneous reporting system is to identify potential postmarket safety issues. There are
inherent limitations to this system, however. For example, there is underreporting and duplicate
reporting; information received may be incomplete; for any given report, there is no certainty
that the reported suspect product(s) caused the reported adverse event(s); and raw counts from
AERS cannot be used to calculate incidence rates or estimates of drug risk for a particular
product or used for comparing risk between products.
Vaccine Adverse Event Reporting System (VAERS)
VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and
Prevention (CDC) and FDA (CBER). VAERS is a postmarket safety surveillance program,
collecting information about adverse events that occur after the administration of U.S. licensed
vaccines. The VAERS Web site provides a nationwide mechanism by which adverse events
following immunization can be reported, analyzed, and made available to the public. The
VAERS Web site also provides a vehicle for disseminating vaccine safety-related information to
parents/guardians, healthcare practitioners, vaccine manufacturers, state vaccine programs, and
other constituencies. The majority of VAERS reports are sent in by vaccine manufacturers and
healthcare practitioners. However, these data are subject to limitations such as underreporting,
simultaneous administration of multiple vaccine antigens (making it difficult to know to which
of the vaccines, if any, the event might be attributed), reporting bias, and lack of incidence rates
in unvaccinated comparison groups. When evaluating data from VAERS, it is important to note
that for any reported event, no cause and effect relationship has been established. The report of
an adverse event to VAERS is not documentation that a vaccine caused the event.
Micromedex Integrated Index
This reference contains a variety of databases covering pharmacology, therapeutics, toxicology,
and diagnostics. This information may be useful for naming because it contains a large number
of product names marketed both domestically and abroad.
Phonological and Orthographic Computer Analysis (POCA)
This application was designed by the FDA. As part of the name similarity assessment, proposed
names are evaluated via a phonological/orthographic algorithm. The proposed proprietary name
is converted into its phonemic representation before it runs through the phonological algorithm.
Likewise, an orthographic algorithm exists that operates in a similar fashion. The source code
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and supporting technical documentation for this tool will be available for public use by the end
of FY 2008.
Drug Facts and Comparisons, online version, St. Louis, MO
Drug Facts and Comparisons, a part of Wolters Kluwer Health, is a compendium developed for
health professionals. The compendium is organized by therapeutic class; contains monographs
on prescription and nonprescription products, with charts comparing similar products.
(http://online.factsandcomparisons.com/index.aspx?)
Drugs@FDA
Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/) is an FDA Web site that
catalogs most of the drug products approved in the United States since 1939. The majority of
labels, approval letters, reviews, and other information are available for drug products approved
from 1998 to the present. Drugs@FDA contains information about FDA-approved brand name
and generic drugs and therapeutic biological products prescription and over-the-counter human
drugs and therapeutic biologicals, and discontinued drugs.
CBER Products
The CBER Products Web site catalogs most of the biologic products currently reviewed by
CBER. Many of the labels, approval letters, reviews, and other information are available for
products approved from 1996 to the present (http://www.fda.gov/cber/products.htm).
Electronic online version of the FDA Orange Book
This Web site provides a compilation of approved drug products with therapeutic equivalence
evaluations (http://www.fda.gov/cder/ob/default.htm).
United States Patent and Trademark Office
This Web site provides information regarding marketed and pending patents and trademarks
(http://www.uspto.gov).
Clinical Pharmacology Online
This resource, provided by Thomson & Thomson’s SAEGIS ™ Online Service, contains full
monographs for the most common drugs in clinical use, plus mini monographs covering
investigational, less common, combination, nutraceutical and nutritional products. It provides a
keyword search engine (www.thomson-thomson.com).
The Pharma In-Use Search Database

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This database contains more than 400,000 unique pharmaceutical trademarks and trade names
that are used in about 50 countries worldwide. The data are provided under license by IMS
HEALTH.
Natural Medicines Comprehensive Databases
This Web site contains up-to-date clinical data on the natural medicines, herbal medicines, and
dietary supplements used in the western world. (http://www.naturaldatabase.com)
Stat!Ref
STAT!Ref, is a subscription-based, online medical reference library that contains full-text
information from approximately 30 texts, including tables and references. Among the database
titles are: Handbook of Adverse Drug Interactions, Rudolph’s Pediatrics, Basic Clinical
Pharmacology and Dictionary of Medical Acronyms Abbreviations. (http://www.statref.com)
USAN Stems
The USAN Council (tri-sponsored by the American Medical Association (AMA), the United
States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA),
aims for global standardization and unification of drug nomenclature and related rules to ensure
that drug information is communicated accurately and unambiguously, working closely with
the International Nonproprietary Name (INN) Programme of the World Health Organization
(WHO), and various national nomenclature groups. This Web site, managed by the AMA,
contains lists of all of the recognized USAN stems.
(http://www.ama-assn.org/ama/pub/category/4782.html)
Red Book Pharmacy’s Fundamental Reference
This reference contains prices and product information for prescription, over-the-counter drugs,
medical devices, and accessories.
Medical Abbreviations Book
Various references on this topic are available. These references contain commonly-used medical
abbreviations and their definitions.

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APPENDIX B:

PROPOSED TEMPLATE FOR A PILOT PROGRAM
SUBMISSION

I.

Table of Contents

II.

Executive Summary

Provide a summary of the overall findings of the proprietary name review including the
rationale as to why the name is acceptable.
III.

Introduction
a. Identify the primary and alternate proprietary name(s).
b. Provide information to support the FDA’s traditional name review 19 and/or
provide the container label, carton labeling, and professional insert in an
Appendix.

IV.

Safety Review
a. Preliminary Screening
Describe the methods used and considerations given to the proprietary name in
the prescreening process. If a proposed name fails the preliminary screening and
is submitted to the FDA for evaluation, describe the rational for pursuing the
name.
b. USAN Stem Search
Include a statement that indicates the name(s) does not contain a USAN stem
along with the date on which this information was searched on the USAN list.
c. Orthographic and Phonological Similarities
Provide the following information: .
•
•
•
•
•
•

All search queries
The system parameters used for each search (e.g., letter substitution)
The precise databases searched
Any thresholds imposed on the output (e.g., top 100, top 200, etc.)
The date the search was conducted or the last update of the database that was
searched
Pooled results with source citation and full product characteristics of each
name identified as a possible source of confusion with the proposed name.

19 FDA is developing guidance on the content of a complete submission for the evaluation of proprietary names.
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Note: Although such searches generate many names that may be ruled out
under further analysis, we request that all names initially identified as a potential
source of confusion be submitted.
d.

Computational Methods
Provide the following information on the computational method(s) used:
•
•
•
•
•
•
•

The measure of similarity/distance used
The values assigned to any adjustable parameters
The manner in which non-name attributes (e.g., strength, dosage form, route
of administration) were handled
If a weighting scheme was used, describe how the different elements were
weighted
The precise database searched (e.g., Orange Book, including or excluding
discontinued products, USPTO (what class), Multum Lexicon).
If a cutoff or threshold was used to narrow or widen the search results, the
cutoff or threshold, and how and why it was chosen
Testing output

e. Medication Error Data
If your proposed product contains an active ingredient that is marketed
domestically or abroad, all available information relevant to medication error
cases associated with that active ingredient should be identified and submitted to
the FDA. Relevant information would include any error reports related to the
product nomenclature, active ingredient, package, and/or the label and labeling.
This information should be identified and reported to the FDA in line listings with
a narrative as described in the box below.
Format for Submitting Relevant Information
•
•
•
•

The FDA recommends that applicants submit a line listing and narratives of the medication error
case reports identified in the postmarket period for marketed products with the same active
ingredient as the product under review.
The applicant should cite the source of the report along with any analysis conducted by the
applicant. Applicants should submit the full text of any article published on medication errors
associated with the product.
Applicants should also categorize these errors by type (e.g., incorrect product, incorrect route of
administration) using the NCC MERP taxonomy.
Applicants should review these cases to identify factors that contributed to the medication errors
and to ascertain whether these risks apply to the proposed proprietary product name. All
medication error data should be integrated into the FMEA.

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f. Name Simulation Studies
Describe all methodology associated with the simulation study including but not
limited to how participants were chosen and the composition and qualifications of
participants.
g. Failure Mode and Effects Analysis
Provide the relevant information to demonstrate that the name will not lead to
confusion. Describe the methods associated with the FMEA (how the team was
chosen, the composition of the team, qualification of its members, the failure
modes identified, and any proposed risk mitigation strategies).
V.

Promotional Review (if applicant chooses to participate in this aspect of pilot)

Describe all research methodology used to support a proposed proprietary name, including a
description of participant demographics; the product profile provided to the study participants;
the complete survey questionnaire; the coding scheme used to analyze open-ended questions;
complete results (both positive and negative), including results of pretests; and any other
information given to the study participants regarding the drug approval process and the
regulations regarding proprietary names.
VI.

Alternative Methods

If the methods used to assess the proposed proprietary name differ from those suggested in the
concept paper for the PDUFA Pilot Project - Proprietary Name Review, submit the rationale for
deviation, a full description of the methods, and all data generated and any analysis of this data
from the alternative test method(s).

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