Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER)

Methodological Approaches to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs: Physician Interviews on Experiences with REMS Programs

Recruitment Message

Dear [Dr. X],

I am a faculty member at Harvard Medical School and Brigham and Women’s Hospital, and I am conducting research on Risk Evaluation and Mitigation Strategy (REMS) programs, which the Food and Drug Administration (FDA) requires manufacturers of certain medications to implement. My project team and I are seeking to better understand the benefits and burdens of REMS programs on patient care. Our work is being conducted on behalf of the FDA and does not involve any pharmaceutical companies.

We are requesting your help as someone who might have prescribed [drug name]—a REMS program-covered drug—in the last year. If so, we would like to invite you to participate in a 60-minute phone interview about your experiences. Should you choose to take part, your answers will be treated confidentially, and you will receive a $100 Amazon gift card as a token of appreciation for your participation. Our work is being conducted on behalf of the FDA and does not involve any pharmaceutical companies. You can find more details in the accompanying Consent Form.

If you meet the above condition and are interested in participating in the study, please email me at [email protected] with the subject line “REMS Patient Interview.”

Thank you very much for your consideration of our invitation.

Best,

Ameet Sarpatwari, Ph.D., J.D.

Assistant Professor of Medicine at Harvard Medical School

Division of Pharmacoepidemiology and Pharmacoeconomics

Brigham and Women's Hospital

1620 Tremont St, Suite 3030

Boston MA 02120

[email protected]