Companies providing information on 1-5 drug products

[AUTHORIZED GENERIC DRUG COMPANY SPECIAL ORDER ]
OMB Control No. [insert]
Expires [insert]1
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION

COMMISSIONERS:

Deborah Platt Majoras, Chairman
Pamela Jones Harbour
Jon Leibowitz
William E. Kovacic
J. Thomas Rosch

FTC Matter No. P062105

ORDER TO FILE SPECIAL REPORT
Pursuant to a resolution of the Federal Trade Commission dated March 28, 2006, entitled
“Resolution Directing The Use Of Compulsory Process,” a copy of which is enclosed, Company
A, hereinafter referred to as the “Company,” is ordered to file a Special Report with the
Commission containing the information specified herein. The enclosed Authorized Generic
Drug Study Federal Register Notice describes the purpose and scope of the information
collection.
Please supply the following information, data, and documents, consistent with the
Definitions and Instructions contained in Appendix A:

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1.

State the full name of the Company and its official address, and its state of
incorporation.

2.

State whether the Company is a subsidiary company; whether the Company has
subsidiary companies; and report the same information specified in Item 1
regarding each parent or subsidiary engaged in research and development,
planning and design, production and manufacturing, distribution, or sales and
marketing of any drug product.

3.

Submit one copy of each organization chart and personnel directory in effect on

Under the Paperwork Reduction Act, as amended, an agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number.

January 1 of each year since January 1, 2001, (a) for the Company as a whole and,
(b) for each of the Company’s subsidiaries or divisions involved in the AG drug
business.
4.

For each AG drug on the list of AG drugs provided by the FTC, state the (a)
proprietary/trade name of the AG, if any; (b) proprietary/trade name of the brandname drug for which the NDA authorizes the marketing of the AG; (c) active
ingredient; (d) dosage form; (e) NDA number of the brand-name drug that
authorizes the marketing of the AG (5 digits, no letter); (f) dosage strength; (g)
14-digit GPI (Medi-Span’s Generic Product Identifier); (h) the AG’s 9-digit
National Drug Code (NDC) number for each strength (labeler and product code
separated by a hyphen); (i) name of the firm/business entity associated with each
NDC labeler code; (j) date of launch for each NDC number; (k) date of
discontinuance for each NDC number, if any; and (l) date of the first public
announcement of the marketing or intended marketing of the AG.

5.

Submit a list of the Company’s orally administered prescription AG drug products
of any capsule or tablet form that were launched after Jan. 1, 2001, but are not on
the FTC’s list of AG drugs (if any), and provide the information requested in Item
4.

6.

Sales of AG drugs, by NDC. For each AG drug addressed in Items 4 and 5, for
sales in the United States from Jan. 1, 2001-March 31, 2007, state the (a)
applicable month and year; (b) the drug identifying information described in the
second paragraph of Instruction (D); (c) the AG’s 11-digit NDC number
(including labeler, product, and package size codes separated by hyphens); (d)
package size; (e) package type; total sales to all customers, net of discounts,
rebates, promotions, returns and chargebacks, in (f) units (as represented by the
NDC’s package size code), and in (g) dollars.

7.

Total sales of AG drugs. For each AG drug addressed in Items 4 and 5, for sales
in the United States from Jan. 1, 2001-March 31, 2007, state the (a) applicable
month and year; (b) the drug identifying information described in the second
paragraph of Instruction (D); (c) the Company’s total sales attributable to all
strengths and package sizes of the dosage form under consideration, net of
discounts, rebates, promotions, returns and chargebacks, in dollars; and (d) the
total sales in prescriptions.

8.

Prices of AG drugs: WAC and AWP. For each AG drug addressed in Items 4 and
5, for sales the United States from Jan. 1, 2001-March 31, 2007, state the (a)
applicable month and year; (b) the drug identifying information described in the
second paragraph of Instruction (D); (c) the AG’s 11-digit NDC number
(including labeler, product, and package size codes separated by hyphens); (d)
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package size; (e) package type; (f) wholesale acquisition cost (“WAC,” see 42
U.S.C. § 1395-3a(b)(6)(B)); and (g) the average wholesale price (“AWP”).
9.

Prices of AG drugs: AMP. For each AG drug addressed in Items 4 and 5, for the
period from Jan. 1, 2001-March 31, 2007, state the (a) applicable quarter and year;
(b) the drug identifying information described in the second paragraph of
Instruction (D); (c) the AG’s 9-digit NDC number (including labeler and product
codes separated by a hyphen); and (d) the average manufacturer price (“AMP”) as
defined by, and reported to, the Centers for Medicare and Medicaid Services
(CMS).

10.

Submit all documents that were prepared by or for any officer(s) or director(s) of
the Company and/or, if applicable, the marketing entity, or that are in the files of
any current or prior Company (and/or marketing entity) senior vice president (or
equivalent position) with product line responsibility (during all or part of the
period from Jan. 1, 2002-April 3, 2006) for an AG drug addressed in Items 4 and
5 (or, in the case of unincorporated entities, individuals exercising similar
functions), as follows. (a) For each AG drug addressed in Items 4 and 5, submit
planning, decisional, or strategy documents prepared from January 1, 2002 to
April 3, 2006, including studies, surveys, analyses, and reports (both internal and
external), that evaluated, considered, or analyzed (but did not merely refer to) the
marketing or possible marketing of an AG or AGs (as a response to current or
future generic competition, or for other reasons), including but not limited to
whether or not to license or otherwise market a brand-name drug product as an
AG drug product; reasons for marketing an AG and/or refraining from marketing
an AG; the timing of AG launch relative to a 180-day exclusivity period; the
marketing of an AG during 180-day exclusivity; the marketing of an AG in the
context of paragraph IV certifications and settlements of litigation; the marketing
of AGs upon expiration of patents or marketing exclusivities claiming a brandname drug product or its use; and the profitability or other benefits of marketing
an AG drug. (b) With respect to AGs in general, submit documents as described
in (a) of this Item.

11.

For the AG drugs addressed in Items 4 and 5: (a) If the Company and the brandname company entered into an agreement that licensed or otherwise authorized
the marketing of the identified drug product as an AG, submit the agreement. (b)
Submit copies of any public announcements, e.g., press release(s), of the planned
marketing or launch of each AG.

12.

Submit planning, decisional, or strategy documents dated Jan. 1, 2006-April 29,
2007 that discuss the effect(s) or possible effect(s) of the enactment of Section

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6003 of the Deficit Reduction Act of 2005, P.L. 109-171,2 on the marketing of
AGs after Jan. 1, 2007.
By direction of the Commission.
Deborah Platt Majoras
Chairman
SEAL

Date of Order:

2

Section 6003 of the Deficit Reduction Act of 2005, P.L. 109-171, which became effective on
Jan. 1, 2007, amends Section 1927(b)(3)(A) of the Social Security Act (42 U.S.C.
§ 1396r–8(b)(3)(A)) to include all drugs approved pursuant to 21 U.S.C. § 355(c), including
AGs, in Medicaid best price calculations.
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APPENDIX A
GENERAL INSTRUCTIONS
A.

Organization of Responses and Due Dates of Parts

The Company’s Special Report must be filed by [date-90 days of receipt].
B.

Responses to Questions

The Special Report should be entered into the Excel spreadsheets provided with this
Order whenever possible. The FTC has entered the question numbers and the information that
must be provided in the header row of each column. To efficiently enter the requested
information, companies may wish to electronically “copy and paste” drug identifying or other
information that must be entered on more than one row or worksheet. When it is not possible to
enter the required answer or information into the applicable worksheet, or no worksheet has been
provided, restate the Item and provide the required answer or information. If any question cannot
be answered fully, give the information that is available and explain in detail in what respects and
why the answer is incomplete.
All responses to Items 1-2 and 4-5 should be submitted to the FTC in both paper and in
electronic form (as Excel, Word, or WordPerfect documents) on machine-readable CDs or
DVDs.
C.

DEFINITIONS

The following definitions apply to all Items:
(1)

“Active ingredient” means a drug’s nonproprietary established name, including the
established names for all active ingredients, as defined at 21 C.F.R. § 299.4 and used in
the Orange Book.3

(2)

“ANDA” means Abbreviated New Drug Application, as set forth in 21 U.S.C. § 355(j).

(3)

“ANDA-generic drug” means a drug marketed or sought to be marketed pursuant an
approved ANDA and usually sold under the established name of the active ingredient(s).

(4)

“Authorized generic (“AG”) drug” means any drug sold, licensed or marketed under an
NDA approved by the FDA under 21 U.S.C. § 355(c); and marketed, sold or distributed

3

See FDA, APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUA TIONS v, 2-2
(27th ed. 2007) [hereinafter Orange Book].
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(directly or indirectly) without using the listed drug’s brand-name and with a different
NDC product number or labeler number (or both).4
(5)

“Brand-name” drug means an innovator drug product marketed pursuant to an approved
NDA under a proprietary, trademark-protected name.

(6)

“Capsule” means all dosage forms of capsules as set forth in Appendix C of the Orange
Book,5 including capsule; capsule, delayed release (DR); capsule, delayed release pellets
(DRP); and capsule, extended release (XR).

(7)

“Company” means Company A, its domestic and foreign parents, predecessors, divisions,
subsidiaries, affiliates, partnerships and joint ventures, and all directors, officers,
employees, agents and representatives of the foregoing. The terms “subsidiary”,
“affiliate” and “joint venture” refer to any person in which there is partial (50 percent or
more) or total ownership or control between the company and any other person. As used
in this definition, the term “person” includes the company and means any natural person,
corporate entity, partnership, association, joint venture, government entity, or trust.

(8)

“Documents” means all computer files and written, recorded, and graphic materials of
every kind in the possession, custody or control of the Company.

(9)

“NDA” means a New Drug Application, as set forth in 21 U.S.C. § 355(b) and approved
under 21 U.S.C. § 355(c).

(10)

“Tablet” means all dosage forms of tablets as set forth in Appendix C of the Orange
Book, including tablet; tablet, chewable (C); tablet, coated particles (CP); tablet, delayed
release (DR); tablet, delayed release, orally disintegrating (DR OD); tablet, extended
release (XR); tablet, orally disintegrating (OD).

4

Generally, AGs are marketed under a different product code, labeler code, trade name,
trademark, and/or packaging (other than repackaging the listed drug for use in institutions) than
the listed drug. See Medicaid Program; Prescription Drugs, 71 Fed. Reg. 77,174, 77,183-84,
77,198 (Dec. 22, 2006). Typically, the name of an AG is the nonproprietary established name of
its active ingredients, but in some cases a trade name different from the brand-name of the listed
drug is used. Also, AGs are usually marketed by a subsidiary or division of the brand-name
manufacturer or a third party in a manner equivalent to the marketing practices of holders of an
approved ANDA for a drug. See Letter from William K. Hubbard, FDA, to Stuart A. Williams,
Mylan Pharmaceuticals, Inc., and James N. Czaban, Heller Ehrman White & McAuliffe 2 n.2
(July 2, 2004) (responding to the citizen petitions of Mylan and Teva regarding AG drugs and
180-day exclusivity).
5
See FDA, APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUA TIONS (27th
ed. 2007).
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D.

Data Submissions

Unless modified by agreement in writing with the staff of the Federal Trade Commission,
all numerical data submitted in response to Items 6-9 must be submitted in a spreadsheet format
both on paper and on machine-readable CDs or DVDs. The Commission will accept database
and spreadsheet data in the following formats: MS Excel, MS Access, tab-delimited or fixed
width text files. All financial information required to be submitted by this Order should be in
whole dollar amounts. For Items 6-9, the applicable month (quarter) and year requested refers to
each month and year for which the Company provides the information called for by the given
Item. If the information is not kept in the form requested, the Company is encouraged to contact
the Commission representative to discuss alternative formats in which the information may be
provided.
To identify the drug for which data is being provided in response to Items 6-9, state on
the applicable row or page the (b)(1) proprietary/trade name of the AG, if any; (b)(2)
proprietary/trade name of the brand-name drug for which the NDA authorizes the marketing of
the AG; (b)(3) active ingredient; (b)(4) dosage form; (b)(5) NDA number (5 digits, no letter) of
the brand-name drug that authorizes the marketing of the AG; and the (b)(6) dosage strength
(except for Item 7). See the Excel spreadsheets provided by the FTC, which should be used to
provide this data whenever possible.
E.

Document Submissions

This Special Order covers documents in the Company’s possession, custody or control,
wherever the documents are located. However, unless or until the Commission notifies
Company otherwise in writing, the Commission will not seek to enforce the Special Order to
compel the production of documents that were located outside the United States at the time
Company received the Special Order. In order to expedite the receipt of documents reflecting the
views of all recipients of Special Orders, the Commission requests your cooperation in producing
any such documents on a voluntary basis by the date specified in this Special Order.
Provide two paper copies of each document. Group the documents by drug product. For
each document, indicate the name of the person from whose files the document came and
whether the document was generated within the Company or externally; if generated externally,
provide the name of the source of the document. All documentary responses should be Batesstamped.
F.

Responsibilities of Company Officials

The Special Report is required to be subscribed and sworn to by an official of the
Company who has prepared or supervised the preparation of the Special Report from books,
records, documents, correspondence, and other data and material in the Company’s possession.
Each subscriber to the Special Report is to give his or her full name, title, and contact
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information in a notarized certification at the end of the Special Report, as set forth in Appendix
B.
G.

Questions

Any questions you have relating to the scope or meaning of this Order, or suggestions for
possible modifications thereto, should be directed to Karen A. Goldman, Federal Trade
Commission, Office of General Counsel, 600 Pennsylvania Ave., N.W., Washington, DC 20580,
(202) 326-2574, kgoldman@ftc.gov.
H.

Submission of Report

The Special Report must be Bates-stamped.
You are advised that penalties may be imposed under applicable provisions of federal law
for failure to file Special Reports or for filing false reports.
Two copies of the Special Report shall be filed with the Secretary, Federal Trade
Commission, Room H-159, 600 Pennsylvania Ave., NW, Washington, DC 20580 by 5:00 PM on
the dates specified herein.

INSTRUCTIONS FOR SPECIFIC ITEMS
1-3.

Self-explanatory.

4.

The FTC has provided a list of AG drugs marketed by the Company during the relevant
time frame that must be addressed in the Company’s Special Report. The list is limited to
AGs that were first launched in the United States after Jan. 1, 2001. A blank list will be
provided if the FTC is not aware of any AGs. Using the Excel spreadsheet containing
this list, enter the information requested in Item 4. Enter the specific dosage form, e.g.,
capsule DR, capsule XR, tablet DR, or tablet XR. Enter each strength for each dosage
form on a different row. When entering the 14-digit GPI, separate the two-digit fields
with dashes.
The response to Item 4(h) should include all of the Company’s 9-digit NDC numbers
used in the marketing, sale, or distribution of the AG in the United States. However, do
not include NDC numbers that cover repackaged or relabeled drug products (such as
those for use in institutions) that were previously sold under one of the aforementioned
NDCs. If the NDCs associated with the AG have changed, provide all NDC numbers that
have been used. If there are multiple NDC numbers for a given strength, each should be
entered on a different row.

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5.

Add to the Excel spreadsheet containing the FTC’s list of AGs any other AGs that fit the
specified criteria but were not on FTC’s list. Follow the instructions for Item 4 for
entering the requested information on these AGs.

6.

Item 6 requests monthly net sales data for AGs for all 11-digit NDCs arising from the 9digit NDCs provided in response to Item 4(h) and Item 5, i.e., including all package size
codes for those NDCs.

7.

The responses to Item 7 represents combined sales from all strengths and NDC numbers.

8.

Item 8 requests monthly WAC and AWP for all 11-digit NDCs arising from the 9-digit
NDCs provided in response to Items 4(h) and 5.

9.

Item 9 requests the quarterly AMP (see 42 U.S.C. § 1396r-8(k)(1)), for all 9-digit NDCs
provided in response to Items 4(h) and 5.

10.

When responding to Item 10(b), do not duplicate documents provided in response to Item
10(a).

11.

For press releases, the source of the document need not be provided.

12.

Self-explanatory.

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APPENDIX B
Certification
This Special Report, together with any and all appendices and attachments thereto, was
prepared and assembled under my supervision in accordance with instructions issued by the
Federal Trade Commission in its Special Orders for the Authorized Generic Drug Study.
Subject to the recognition that, where so indicated, reasonable estimates have been made
because books and records do not provide the required information, the information is, to the
best of my knowledge, true, correct, and complete. Where copies rather than original documents
have been submitted, the copies are true, correct, and complete.

TYPE OR PRINT NAME AND TITLE

TYPE OR PRINT COMPANY NAME AND ADDRESS

TYPE OR PRINT PHONE NUMBER AND E-MAIL ADDRESS

(Signature)
Subscribed and sworn to before me at the City of
State of
of

, this
, 20

day

.

(Notary Public)
My Commission Expires:

10

,