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

[Date]
[Name
Position
Address
Address
Address]
Dear [Name],
Hello. My name is Joshua Gagne, and I’m a researcher at Brigham and Women’s Hospital and
Harvard Medical School. I am leading a research project funded by the US Food and Drug
Administration’s Office of Generic Drugs to better understand how authorized generic drugs can
be used to improve safety surveillance for generic drug products. [Physicians’/pharmacists’] are
uniquely positioned to help us understand the role of authorized generics.
I am writing to request the input of [physicians’/pharmacists’] into this project through
participation in a focus group discussion. The focus groups will be held at the Brigham and
Women’s Hospital in Boston from [start time] to [end time] on [date] and we are offering a
[$250/$150] honorarium for your participation.
In order to qualify, participants must [spend at least 50% of their time practicing primary
care/practice in a retail pharmacy setting] to ensure reasonable opportunity for exposure to
authorized generic products and must be in the Boston area in order to facilitate travel to the
Brigham and Women’s Hospital for the in-person focus group. However, no prior knowledge of
authorized generic drugs is necessary.
The focus group will gather small groups of physicians/pharmacists to talk for 1.5 - 2 hours
about issues related to authorized generics, including knowledge of and experience with
authorized generics; opinions about whether, when, and why authorized generics should be
preferred over brand-name or other generic products; and the price premium that should be
placed on authorized generics relative to other products.
The focus groups will be led by Joshua Gagne, PharmD, ScD and Michael Fischer, MD, MSc.
The sessions will be audio recorded. At the start of the focus group, participants will be asked to
provide verbal consent to participate and to have their conversation recorded. Dr. Gagne or Dr.
Fischer will note this in the research record. Individuals who do not give verbal consent will not
participate in the focus groups. No personal information will be linked to individual
participants’ focus group content.
If you are interested in participating, or have any questions, please contact project assistant
Nazleen Khan at [phone] or [email] as soon as possible, as available spots will be filled on a
first-come-first-served basis (though there may be some exceptions to ensure a diversity of
participants).
Sincerely,

Joshua Gagne, PharmD, ScD
Assistant Professor of Medicine, Brigham and Women’s Hospital