Attachment D_Moderator Guide

Moderator Guide: Social Media and Prescription Drugs

OMB Control No. 0910-0847

Expiration date: 02/28/2026

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The time required to complete this information collection is estimated to average 60 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

Thanks for joining us today. I’m _____, and I’m from RTI International, a nonprofit research organization based here in North Carolina. _______ is also joining us from RTI and will be taking notes. The U.S. Food and Drug Administration (FDA) is sponsoring this project to hear your thoughts about how drugs are promoted on social media. Your feedback is very important to us, and your time today is appreciated. We will have about 60 minutes for our discussion.

Before we begin, I would like to review a few items that were covered in the consent form. This is the form we sent when you were confirmed for the study:

• Participation. First, your participation is voluntary, and you can stop participating at any time. If at any time you are uncomfortable with any question, you can choose not to answer.

• Recording. To make sure that we capture your feedback today, we will be audio and video recording today’s session. This recording will also be transcribed. However, your name or any identifying information about you will not be included or associated with the project in any way.

• Privacy. Your name, which the RTI project team knows, will not be given to anyone else, and no one will contact you about this study after this session is over. We ask that you be careful and not share any identifying information about yourself such as your last name or full birth date. If you are speaking about someone else, please do not share their name or other identifying information.

• Observers. We may have some members of the study team, including staff from the FDA, watching the session remotely so that they can hear your thoughts directly from you. They will have their cameras off and microphones muted, so they won’t be participating in the discussion.

Do you have any questions before we begin? [Moderator answers questions.]

Do I have your verbal consent for the interview? ¨ Yes ¨ No

Do I have your consent to start the recording? ¨ Yes ¨ No [If yes, start recording. If no, talk to participant about concerns. Dismiss participant from interview if they do not consent to recording.]

Before we begin, let me know your first name and what you would be doing if you weren’t with me here today?

[Moderator introduces themselves.]

Opening Questions

1. If you wanted to learn more about a prescription drug, where would you go?

2. [If not mentioned] Would you go to Facebook?

   1. Why or why not?

   2. If so, where exactly would you look? (Probe on use of search, what they would look for? e.g., Patient group or pharma page)

3. [If not mentioned] Would you go to Instagram?

   1. Why or why not?

Current drugs

4. My understanding is that you are currently taking a medication for your diabetes. What drug are you taking?

• Acarbose (Glucobay, Precose, Prandase)

• Alogliptin (Nesina)

• Canagliflozin (Invokana)

• Dapagliflozin (Farxiga)

• Dulaglutide (Trulicity)

• Empagliflozin (Jardiance)

• Ertugliflozin (Steglatro)

• Exenatide (Byetta, Bydureon Bcise)

• Glimepiride (Amaryl)

• Glipizide (Glucotrol XL)

• Glyburide (DiaBeta, Glynase)

• Linagliptin (Tradjenta)

• Liraglutide (Saxenda, Victoza)

• Lixisenatide (Adlyxin)

• Metformin (Fortamet, Glumetza, others)

• Miglitol (Glyset)

• Nateglinide (Starlix)

• Pioglitazone (Actos)

• Pramlintide (Symlin)

• Repaglinide (Prandin)

• Rosiglitazone (Avandia)

• Saxagliptin (Onglyza)

• Semaglutide (Ozempic, Rybelsus, Wegovy)

• Sitagliptin (Januvia)

Other (please type here): ____________________________

Initial Search Approach, Finding Official Page

Imagine you wanted to learn about the drug [DRUG] on [FACEBOOK/INSTAGRAM] because it’s a drug that you feel might be right for you or a loved one. It’s possible that [DRUG] is a drug you wouldn’t consider; that’s okay, this is just hypothetical. I’ve opened up [FACEBOOK/INSTAGRAM] on the [PHONE/LAPTOP].

5. On [FACEBOOK/INSTAGRAM] show me what you would do to find information. Here is how you spell the drug [Moderator spells out]

OBSERVE: [RQ1, RQ2] Does participant do the following?

• Go to the official [DRUG] page/profile ¨ Yes ¨ No

• Click on the warning/risk information ¨ Yes ¨ No

• Click on indications information ¨ Yes ¨ No

Moderator records other elements clicked on

6. [RQ1] Tell me a little more about why you clicked on what you did?

   1. What made you click on it?

7. [RQ1] How do you know what information to look at?

8. Can you tell if the information/page/profile you are looking at is made by a pharmaceutical company, someone on [platform], or is it not clear?

TASK

[If participants is not already on the official page, help them navigate to that page. Provide time to read page if needed]

9. [RQ4] After looking at this page, do you feel you know what the risks are of the drug?

10. [RQ4] After looking at this page, do you feel you know what the drug is for?

    1. [If Yes] What is it for?

Facebook Pages for Testing

Internal Reference in Guide	Facebook Drug 1 (FD1)	Facebook Drug 2 (FD2)	Facebook Drug 3 (FD3)
Condition	Diabetes	Diabetes	High Cholesterol
Safety Information disclaimer in cover photo as text?	No	Yes	Yes
Safety Information: Appears on caption of cover photo when clicking on cover photo?	No	No	Yes
Safety Information: Appears in “About” tab	Yes	Yes	Yes
Verified Account?	Yes	Yes	Yes
Are audience engagements (likes, comments) allowed on posts? And does account owner reply to comments	Yes	No	No

Blue Shading = Differences between drugs

Instagram Pages for Testing

Internal Reference in Guide	Instagram Drug 1 (ID1)	Instagram Drug 2 (ID2)	Instagram Drug 3 (ID3)
Safety Info: As a story?	Yes, as a static photo	Yes, as a static photo	Yes, as a scrolling video
Safety Information: Is it the first story?	No	No	Yes
Safety Information: Can be found in link?	Yes, but at the bottom of a long list of links labeled as “Medication Guide”. Drug maker uses “LinkTree” to provide list of link.	Not clearly labeled. Can be found in the first link. Drug maker uses “LinkTree” to provide list of link.	Hard to find. Drug maker links directly to a Medication Guide PDF.
Verified Account?	No	No	Yes

Blue Shading = Differences between drugs

Facebook and Instagram Page-Level Questions

Next, I’m going to have you visit pages on [FACEBOOK/INSTAGRAM].

[MODERATOR: Half participants see Drug 1, Drug 2, then Drug 3. Other half see Drug 3, Drug 1, then Drug 2.]

11. [All drugs] I’m going to have you look for [DRUG]. First, have you heard of [DRUG] before?

    1. What do you know about it?

TASK: Click on the ‘search’ button and type [DRUG NAME]. Here is how you spell it. [MODERATOR SPELLS OUT DRUG NAME.]

12. [All drugs] Looking at the search results, can you tell which page is the official page for the drug?

    1. How can you tell?

IF NOT ON CORRECT PAGE -- TASK: [Moderator takes participant to correct page.]

Take a couple minutes to explore the page on your own to learn more about [DRUG]. We’ll talk more once you are done.

OBSERVE: [RQ1, RQ2 – All drugs] Does participant click on the following?

• Safety information ¨ Yes ¨ No

• Indications information ¨ Yes ¨ No

• External links ¨ Yes ¨ No

• [Facebook] About page ¨ Yes ¨ No

• [Facebook – FD1] Audience engagements on posts ¨ Yes ¨ No

• [Instagram] Stories ¨ Yes ¨ No

• [Instagram] An individual post ¨ Yes ¨ No

[MODERATOR: After participant says they are finished, ask the following questions.]

13. [RQ3 – All drugs] Overall, what do you think about the page?

14. [RQ1 - ID3 – VERIFIED ACCOUNT] What does the blue check mark next to the drug’s name means at the top of the page?

    1. Does having a verified account affect your trust of the information?

15. [RQ4 – All drugs] Imagine you were worried about nausea as a side effect. Would you know where to look to find that?

    1. Where would you go?/Where do you think you would go?

16. [RQ4 – All drugs] After looking at this page, do you feel you know what the drug is for?

    1. [If Yes] What is it for?

17. [RQ1 – All drugs] Did you see the safety, warning, or risk information for the drug?

    1. [If yes] Where did you find it?

       1. [FD3 – Confirm whether they found the safety information in the “About” tab or the cover photo or both]

       2. [ID1, ID2, ID3 – Confirm whether they found the safety information in the story or link or both]

    2. [If only saw the information on the cover photo – FD3] Would you read all of the safety information in the comment of the photo?

    3. [ID1, ID2 – SEVERAL STATIC PHOTOS IN A STORY] How do you pause the story to read the safety information?

       1. Would you pause the story to read the safety information?

    4. [ID3 – SCROLLING VIDEO] Would you watch the entire video to read the safety information?

• [If did NOT see information] I want to show you where the information is. [Moderator provides assistance.] Take a moment to read over the information. [Moderator pauses to give time to read, and then will ask the next question.]

18. [RQ1 – All drugs] How easy or hard (is it/was it) to find the information?

• What could make it easier to find?

• How useful was the information, for example, if you wanted to know the side effects?

• Did you read all the information?

  1. [If no] What parts did you read, if any?

• If you weren’t here today, would you review all the information?

  1. [If no] What information would you review? Why?

19. [RQ4 – All drugs] What is confusing or unclear about the warning information?

20. [RQ1 - FD1 – PAGE ALLOWS FOR ENGAGEMENT] Some pages for drugs allow people to engage in posts on the page by liking or commenting on the post. If you were looking for more information on the drug, would you read comments made on the posts?

21. [RQ3 – All drugs] After looking at all the information presented on [DRUG’S] [FACEBOOK/INSTAGRAM] page, are you more interested in the drug, less interested, or unchanged?

22. [RQ3 – All drugs] After looking at all the information presented on [DRUG’S] [FACEBOOK/INSTAGRAM] page, would you want to talk to your doctor about [DRUG]? Why or why not?

23. [RQ3 – All drugs] Knowing this page is made by the pharmaceutical company, how does this affect your trust of the information?

24. [Ask only once.] What role, if any, do you think the FDA has in reviewing the accuracy of the information on the page you are looking at?

P [MODERATOR REPEATS QUESTIONS FOR 2^ND AND 3^RD DRUG.]

Facebook Posts for Testing

Internal Reference in Guide	Facebook Post 1 (FP1)	Facebook Post 2 (FP2)	Facebook Post 3 (FP3)	Facebook Post 4 (FP4)
Type of Post	Video	Video	Text only	Video
Is safety information shown?	Yes	Yes	Yes	Yes
Does post focus only on safety information?	Yes	No	Yes	No
Is safety information shown as static text or scrolling?	Scrolling, whole frame	Scrolling, bottom 1/3 of video	Static Text	Scrolling, bottom 1/3 of video
If video, when is safety information shown	Immediately	At the end of the video. Risk information is paused until message in top 2/3 of video is finished.	n/a	Immediately. Risk information plays while the top 2/3 of the video is also playing
Is safety information shown in caption?	No	No	n/a	No, but a hyperlink links to full prescribing information
Other notes			Pinned post at top. Requires hitting “see more” to see all warnings. (This is a Facebook limitation.) Company allows comments on posts. The company responds to user comments.

Instagram Posts for Testing

Internal Reference in Guide	Instagram Post 1 (IP1)	Instagram Post 2 (IP2)	Instagram Post 3 (IP3)	Instagram Post 4 (IP4)
Type of Post	Video	Photo	Video	Video
Is safety information shown?	Yes	Yes	Yes	Yes
Does post focus only on safety information?	No	No	No	No
If video, is safety information shown as static text or scrolling?	Static Image	n/a	Some is static text with a voiceover. Then additional safety info shown scrolling with no voiceover.	Scrolling in bottom 1/3 of video
If video, when is safety information shown	At the end of the video	n/a	At the start of the video, there is a note that safety info appears at the end.	At the end of the video. Risk information is paused until message in top 2/3 of video is finished.
Is safety information in caption?	No	Yes, but must click on “more” to see caption	Yes, but must click on “more” to see caption	No

Blue Shading = Differences between drugs

Facebook and Instagram Post-Level Questions

TASK:

[Moderator takes device, and takes participant to a certain post.]

Take a couple minutes to explore the post on your own to learn more about [DRUG]. We’ll talk more once you are done.

OBSERVE: [RQ1, RQ2 – All posts] Does participant click on the following?

• “See more” (if applicable) to expand text ¨ Yes ¨ No

• [Facebook] External links ¨ Yes ¨ No

• [Facebook] Button to start video [if applicable] ¨ Yes ¨ No

25. [RQ3 – All posts] Overall, what do you think about the post?

26. [RQ1 – All posts] Would you normally [WATCH/READ] the entire post?

    1. [IP1 – PAID PARTNERSHIP] Does the paid partnership with [PERSON] change how you would watch the video?

       1. [If needed] Would you be more or less likely to watch the whole video because of [person]?

27. [RQ2 – All posts] If you saw this post, would you click on anything? Why/why not?

    1. If so, what?

28. [RQ4 – All posts] Imagine you were worried about nausea as a side effect. Would you know where to look to find that?

    1. What would you do to find the information?

29. [RQ4 – All posts] After looking at this post, do you feel you know what the risks of the drug are?

    1. What are they?

    2. [RQ1 – IP2, IP3 – MUST CLICK ON “MORE” TO SEE SAFETY INFORMATION IN CAPTION] Would you click on “more” if you saw it in a post?

       1. Did you expect to see safety information in the caption when you clicked on “more”?

    3. [RQ3 – IP1 – NO RISKS ARE SHOWN IN THE POST] Should side effects be shown in the video?

30. [RQ1 – FP1, FP2, FP4, IP3, IP4 - SAFETY INFORMATION IS A SCROLLING VIDEO] The safety information is currently shown in a video that scrolls. Does this make you more or less likely to read all the information?

• How do you pause the video if you need more time to read the information?

• Would you prefer it scroll automatically, or would you prefer being able to control the scroll yourself?

31. [RQ1 – If FP4 – RISK INFORMATION SCROLLING ON BOTTOM 1/3 OF VIDEO WHILE TOP 2/3 IS ALSO PLAYING] Did you read the information that was scrolling at the bottom while also looking at the top part of the video?

32. [RQ4 - If comments] This post has comments. How does that affect what you think of it?

33. [RQ4 - FACEBOOK - If reactions] This post also has “reactions”, where people can “like” a post or use other reaction buttons. How does that affect what you think of the post?

34. [RQ4 - INSTAGRAM] This post also has “likes”, where people can “like” a post. How does that affect what you think of the post?

35. [RQ1 - FACEBOOK - ASK at END after all posts are shown] I’ve shown you different posts that show warning information differently. Sometimes the information was a scrolling video that filled the frame, sometimes a scrolling video that filled a third of the frame, and sometimes the information was pasted in a text in the post.

    1. For which presentation are you most likely to read all the information?

    2. For which presentation are you most likely to not read all the information?

    3. For which presentation makes it easiest to understand the information?

    4. For which presentation makes it hardest to understand the information?