pregnancy and nursing mm study LETTER AttachmentB

Attachment B

HHS/FDA Letterhead

<Date>

(Doctor’s Name and Address)

Dear Dr. ________________,

I am writing to invite you to consider participating in a research study that Decision Partners (DP), an independent research firm, is conducting on behalf of the U.S. Food and Drug Administration (FDA). This study is part of an important initiative to improve how drug information is communicated to health care providers who treat women who are or who may become pregnant, or women who are nursing.

Your participation in this study would involve being interviewed over the telephone by a professional researcher at a pre-arranged time that is convenient for you. If you indicate your willingness to participate, your name will be included in a pool of candidates from which a sample will be drawn for interviewing. If selected, DP will contact you to schedule an interview. The interview is expected to take between 45 to 60 minutes. The results of this research study may be published on the FDA’s website as well as in professional publications.

Your participation is strictly voluntary and FDA will not know whether or not you choose to participate. Should you participate, your responses will be kept completely confidential. No comments in research reports provided to the FDA will be attributed to you or any other specific individual.

As a token of our appreciation, we will offer you a $150 honorarium for participating in the interview. We understand that this is a small amount for your time, but hope that you will take this opportunity to help FDA improve how drug information is communicated to health care providers who treat women who are or may become pregnant. We look forward to your reply.

If you wish to participate, please contact Jan Vonk, Decision Partners Project Coordinator, either by email at jvonk@decisionpartners.com, by phone at (877) 588-9106 or by FAX at (866) 344-5510. Alternatively, if you wish to respond by letter, please write to:

Jan Vonk, Project Coordinator

Decision Partners LLC

313 East Carson St.

Suite 200

Pittsburgh, PA 15219

Thank you for your consideration.

Sincerely,

Kathleen Uhl, M.D.

U.S. Food and Drug Administration

Assistant Commissioner for Women’s Health