JAMA: REMS mitigate drug risks, FDA often release 💊 from the restictions w/o disclousing rationale
The US Food and Drug Administration (FDA) Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and Mitigation Strategy (REMS) to “ensure the benefits of the medication outweigh its risks.” Since its inception, the REMS program has evolved, with the less restrictive strategies either released from te program (medication guides) or used less often (communication plans) and the more restrictive ETASUs used most commonly. Medications released from the REMS program are no longer subjected to FDA-mandated periodic assessments to determine the effectiveness of previous or ongoing risk mitigation strategies.
Guadamuz JS, Qato DM, Alexander GC. (2020) Use of Risk Evaluation and Mitigation Strategies by the U.S. Food and Drug Administration, 2008-2019. Published in JAMA.