Brown BL, Wood SF, Sarpatwari A - Annals of Internal Medicine
The FDA’s REMS program for mifepristone is not justified by the drug’s safety profile and creates access barriers, particularly for low-income and rural patients, that were exacerbated by the COVID-19 pandemic. The authors contend that the REMS requirements may paradoxically push patients toward later surgical abortions that carry greater risk.
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Eisenkraft Klein D, Kesselheim AS - Clinical Pharmacology & Therapeutics
Daval CJR, Kesselheim AS - STAT
Cai CL, Bucha S, Kesselheim AS, Rome BN - Journal of General Internal Medicine