Focus Groups to assess the post-marketing safety of authorized generic drug products

Authorized Generics: Guide for focus group with physicians/pharmacists
INTRODUCTION
Thank you for attending this focus group discussion today. My name is Joshua Gagne and I will
be leading this discussion with my co-facilitator, Michael Fischer. You are all here because you
are [physicians who spend at least 50% of your time practicing in primary care/pharmacists who
practice in retail settings]. During this 120-minute session, we will ask you to talk about your
thoughts about generic drugs and brand-name drugs.
Before we begin, I would like to go over a few ground rules:
• First, we hope that you will feel comfortable discussing your views in this format.
However, we realize that it is possible that some of you may feel uncomfortable or
uneasy sharing your thoughts and understandings. If you feel that you do not want to
answer a question or participate in the discussion we fully respect your decision.
• It is important that this discussion remains confidential. Please use only your first name
and please refer to others by first name only. That will allow us to maintain as much
anonymity on the tape recording as possible.
• We expect that people might have different experiences and opinions and we would like
to hear all viewpoints. Please feel free to share your feelings and opinions, even if you
disagree with what has already been said.
• I would also like to remind you that today’s discussion will be tape recorded. We record
all conversations so that we have an accurate and complete report of what was said. You
will not be identified on the tape other than by your first name. The tape will be
transcribed into a written form, although your name will not be part of the written form.
The tapes and transcripts will be available only to the research team, will not be used for
any other purpose than this project, and will be destroyed at end of the project.
• It is important that only one person speaks at a time, and please speak up so we can
capture all of your comments. If there is more than one person speaking at a time, it is
very difficult to transcribe. We need to be able to hear what everyone says so that we can
produce an accurate report of the discussion.
• Because this is a group discussion, I will try to make sure that everyone has a chance to
speak but that no one dominates the discussion; so please don’t be offended if I gently
interrupt.
Finally, before we begin, I need to ask you whether you consent to participate in the focus group.
Because we are not capturing any personal information, we will not record individual responses.
We will only record that all participants provided verbal consent. We will go around the table.
Please respond to the following questions with a ‘Yes’ or a ‘No’. Do you consent to participate
in this focus group?
[If anyone does not consent, they will be asked to leave]
Are there any questions before we begin? We have a lot to discuss, so let’s get started.
First, please tell us your first name. If it is all right, I will turn on the recorder and begin the

discussion.
The first questions are to understand your knowledge of authorized generic drugs.
1. How familiar are you with the concept of an authorized generic?
After discussion of #1: To ensure that we are all on the same page about what authorized generic
drugs are, I will briefly describe brand-name drugs, generic drugs, and authorized generic drugs,
in particular. Brand-name drugs are FDA-approved drugs that are usually approved through a
new drug application and are protected by a patent for some period. Brand-name drugs are
typically produced by a single manufacturer.
Generic medications contain the same amount of the same active ingredient as their brand-name
counterparts and can be approved by the FDA after the brand-name drug’s patent has expired.
Generic drugs are approved through an abbreviated new drug application in which the
manufacturer must demonstrate bioequivalence to the approved brand-name product, but do not
need to repeat all of the lengthy and costly pre-approval clinical trials. As a result, generic drugs
are much less costly than their brand-name counterparts and therefore reduce overall health
system spending.
An “authorized generic drug” is a listed drug as defined in § 314.3 that has been approved under
subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail
class of trade with either labeling, packaging (other than repackaging as the listed drug in blister
packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade
name, or trade mark that differs from that of the listed drug.
Another way to think about authorized generics are that they are brand-name drugs that are
marketed, sold, or distributed as generic medications, usually either by a subsidiary of the brandname manufacturer or by another company licensed to do so. Since they are produced by the
brand-name manufacturer, authorized generics are chemically-identical to the brand-name
versions because they contain exactly the same active and inactive ingredients as the brand-name
version, but they may differ in labeling, packaging, product code, labeler code, trade name, or
trademark. Authorized generic are different from so-called “branded generics” which are
actually independent generics approved under the abbreviated pathway that the generic
manufacturer assigns a proprietary name to. We will not be talking specifically about branded
generics.
2. Are there any questions about brand-name drugs, generic drugs, and authorized generic
drugs?
3. How frequently are you aware that your patients are using authorized generics?
The next set of questions are intended to understand your opinions about authorized generic
drugs based both on your prior knowledge and experience with these products, if any, and based
on the discussion we just had.
4. Would you prefer that your patients use an authorized generic instead of another generic
product? If so, under what circumstances? Why?

5. In what ways do you think the safety and effectiveness of authorized generics, nonauthorized generics, and brand-name drugs differ?
6. What would be appropriate copayments for brand-name drugs, authorized generics, and nonauthorized generics?
7. To what extent do prescription drug costs impact patients’ adherence to prescribed therapy?
If at all, to what extent do you think that differences in price between brand-name versions,
authorized generics, and other generic drugs affect adherence?
One distinction between authorized generic drugs and other generic drugs is that the authorized
generic drugs typically share the same appearance as the brand-name products. In particular,
authorized generic drugs usually have the same color, size, and shape as the brand-name product.
In contrast, independent (non-authorized) generic drugs typically look different from the brandname products. Also, generic versions produced by multiple manufacturers typically look
different from each other. Research has shown that patients who refill the same dose of the same
medication experience changes in pill appearance in up to 30% of refills.
8. Does this information change whether or when you would prefer that your patients use an
authorized generic instead of a brand-name product? If so, how?
9. How important is it that patients receive pills that look the same with each refill?
10. How important is it that patients receive pills from the same manufacturer with each refill?
That concludes our questions. Are there any questions we should have asked about that we did
not cover? Do you have other comments or thoughts you wish to share?