FDA REMS

About our study:

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

Participation opportunities:

Xyrem or Xywav
(sodium oxybate)

Have you started taking Xyrem or Xywav (sodium oxybate) in the past 3 years?
If yes, we want to talk to you!

We would like to extend an invitation to individuals age 18 or above who started taking Xyrem or Xywav (sodium oxybate)—a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.

If you meet the above criteria and are interested in participating in the study, please email asarpatwari@bwh.harvard.edu for more information.

Study Team

Ameet Sarpatwari, PhD, JD
Aaron S. Kesselheim MD, JD, MPH
Will Feldman, MD, DPhil
Mayookha (Tuli) Mitra-Majumdar, MPH
Beatrice Brown, MBE
Aviva Wang, MS
Heidi Zakoul, BA
Su Been Lee, BA

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