Focus Groups to Investigate Specific Terminology in Prescription Drug Promotion

FOCUS GROUPS ABOUT DRUG PRODUCTS

FDA CDER MODERATORS GUIDE - DTC ADS 10-30-13

Focus Groups to Investigate Specific Terminology in Prescription Drug Promotion

OMB: 0910-0677

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Moderator’s Guide

Terminology in DTC Ads



I. Introduction of Moderator

A. Independent consultant hired to moderate these discussions

B. No vested interest in receiving any particular point of view


II. Ground Rules


A. You have been asked here to offer your views and opinions; everyone’s participation is important

B. Audio/observers

C. Speak one at a time

D. No side conversations

E. No right or wrong answers

F. It’s OK to be critical. If you dislike something or disagree with something that’s said, I want to hear about it.

G. All answers are confidential, so feel free to speak your mind.


III. Introduction of Topic


You may have noticed ads for prescription drugs presented on television, in magazines and newspapers, as well as in other contexts. The U.S. Department of Health and Human Services, also called DHHS, has noticed that some of the same words often appear in different ads for prescription drugs. They need your help to find out what those phrases mean to you. By understanding what you think the phrases are saying, they can better understand what the ads are communicating to the general public.


It is important to note that we are not here to talk about whether these ads should or should not exist or whether they are good or bad—that is a whole different session. For this discussion, we are going to think about what’s in the ads.


I’d like to begin by getting to know all of you a little and then I will go into further detail about what we are doing in this session.


IV. Participant Introductions


To begin, I’d like to have you go around the table and introduce yourselves. Please give me:

a. your first name only

b. how long you have lived in the area

c. one personal interest


V. Natural

[Moderator: Tell participants that the group will discuss the term “natural” and tell them to think about the term for two minutes. Provide a pad of paper and pen so they can jot down thoughts they have about the term.]


General thoughts about the term “natural”


What do you think of when you hear the word “natural”?


What are some images that come to your mind when you hear the word “natural”?


Is natural a good thing or a bad thing and why?


Thoughts about “natural” products in general


If a product is a “natural” product, what does that mean to you?


What are some examples of “natural” products you can think of?


What makes a product “natural”? What criteria must be met for a product to be “natural”?


When you shop, do you look for natural products? Why or why not?


Would you pay more for natural products? Why or why not?


Thoughts about “natural” in prescription drug promotion


What does it mean if a prescription drug is “natural”?


[Healthcare Professionals:] Does the term “natural” mean different things depending on the indication or body system?

(e.g., immune system, sleep, oncology, cholesterol, acne, hormone replacement therapy…)

[Consumers:] Does the term “natural” mean different things depending on what the drug treats or what body system it works on?

(e.g., immune system, sleep, oncology, cholesterol, acne, hormone replacement therapy…)


Are prescription drugs that are “natural” safer than drugs that are made in a lab?


Are prescription drugs that are “natural” more effective than drugs that are made in a lab?


Are there any other characteristics of “natural” products that we have not mentioned yet?


Thoughts about claims of “natural” in drug information


What do you expect when you see a claim of “natural” in an ad for a prescription drug?


What are the characteristics of a prescription drug that would allow it to be called “natural”?


Do you think that the term “natural” is used the same way across all different types of prescription drugs?


Do you think any group regulates and standardizes the way “natural” is used? What group would that be and what do you think the requirements might be?


Do you have any other comments or suggestions?


Examples of “natural” in promotion


Show several examples of ads with the term or concept of “natural” in them.


Now that we’ve talked about the term “natural,” what do you think of the use of “natural” in this ad?


Would this piece influence your decision to talk to your doctor about the product (consumers)/ prescribe the product (healthcare providers)?


VI. Targeted


[Moderator: Tell participants that the group will discuss the term “targeted” and tell them to think about the term for two minutes. Provide a pad of paper and pen so they can jot down thoughts they have about the term.]


General thoughts about the term “targeted”


What do you think of when you hear the word “targeted”?


What are some images that come to your mind when you hear the word “targeted”?


Is targeted a good thing or a bad thing and why?


Thoughts about “targeted” products in general


If a product is a “targeted” product, what does that mean to you?


What are some examples of “targeted” products you can think of?


What makes a product “targeted”? What criteria must be met for a product to be “targeted”?


When you shop, do you look for targeted products? Why or why not?


Would you pay more for targeted products? Why or why not?


Thoughts about “targeted” in prescription drug promotion


What does it mean if a prescription drug is “targeted”?


[Healthcare Professionals:] Does the term “targeted” mean different things depending on the indication or body system?

(e.g., immune system, sleep, oncology, cholesterol, acne, hormone replacement therapy…)

[Consumers:] Does the term “targeted” mean different things depending on what the drug treats or what body system it works on?

(e.g., immune system, sleep, oncology, cholesterol, acne, hormone replacement therapy…)


Are prescription drugs that are “targeted” safer than drugs that are made in a lab?


Are prescription drugs that are “targeted” more effective than drugs that are made in a lab?


Are there any other characteristics of “targeted” products that we have not mentioned yet?


Thoughts about claims of “targeted” in drug information


What do you expect when you see a claim of “targeted” in an ad for a prescription drug?


What are the characteristics of a prescription drug that would allow it to be called “targeted”?


Do you think that the term “targeted” is used the same way across all different types of prescription drugs?


Do you think any group regulates and standardizes the way “targeted” is used? What group would that be and what do you think the requirements might be?


Do you have any other comments or suggestions?


Examples of “targeted” in promotion


Show several examples of ads with the term or concept of “targeted” in them.


Now that we’ve talked about the term “targeted,” what do you think of the use of “targeted” in this ad?


Would this piece influence your decision to talk to your doctor about the product (consumers)/ prescribe the product (healthcare providers)?



VII. Indication statements


Thoughts about the “indication statement” in prescription drug promotion


Next, I’d like to ask you some questions about the indication statement in prescription drug ads. The indication statement of a drug refers to its intended purpose. It refers to the diseases and symptoms that may be treated by using a specific drug.


Show several examples.


What comes to mind when you see these indication statements?


What does the indication statement tell you about [consumers:] how well the drug works? [healthcare professionals]: the drug’s efficacy?


Do these statements suggest anything about the possible risks of the drug?


How safe do you think this drug is?


VIII. Closing


Moderator: Check with observers for additional questions.


Thank participants for the discussion and dismiss them.



File Typeapplication/msword
AuthorO'Donoghue, Amie
Last Modified ByMizrachi, Ila
File Modified2013-10-30
File Created2013-10-24

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