Enforcement Discretion: FDA relaxes enforcement of Risk Evaluation Mitigation Strategy (REMS)
Texans for Life Coalition -- Kyleen Wright – President
P.O. Box 171443
Arlington, Texas 76003
TLC Policy Analysis:
Enforcement Discretion: FDA relaxes enforcement of Risk Evaluation Mitigation Strategy (REMS) Program for Mifepristone
In a letter to the American College of Obstetricians and Gynecologists this week, acting director of the US Food and Drug (FDA) Administration Commissioner Janet Woodcock acknowledged that the agency intends to exercise enforcement discretion on prescribing for the abortion-inducing medication mifepristone. Such enforcement discretion offsets the January, 2021 Supreme Court ruling to keep the in place FDA guidelines requiring in-person exams before providers can use telehealth to prescribe mifepristone. This is a move that allows healthcare providers to prescribe mifepristone and monitor the procedure via telehealth. The Biden Administration has indicated support for the use of telehealth to facilitate medication abortions during the coronavirus pandemic.
Highlights of the types of risks posed by the FDA decision:
As of 2018, 50% of abortions in the United States were drug induced (Kortsmith et al., 2020).
A records-linkage study of approximately 42,000 abortions documented that the overall incidence of adverse events was four times higher in medical compared surgical abortions (Niinimaki, et al., 2009).
Lifting enforcement of REMS provides out-of-state practitioners the opportunity to sidestep state laws explicitly restricting medication abortion via telemedicine, laws requiring in-person administration of mifepristone, as well as laws applying more generally to the dispensing of medications by mail.
Lack of FDA oversight on chemical abortions leads to lack of reporting adverse events if they are non-fatal.
Lack of FDA oversight increases the likelihood of black market sale of chemical abortion pills.
Allows doctors to by-pass state Health and Safety Code requirements.
Without an in-person doctor visit exposes women to potentially serious health risks.
The FDA’s literature review failed to include numerous studies and articles that have found the abortion pill leads to elevated health risks and deprives women of critical medical information and safety precautions related to the use of abortion pills.
Kortsmit K, Jatlaoui TC, Mandel MG, et al.(2020). Abortion Surveillance — United States, 2018. MMWR Surveill Summ 2020;69(No. SS-7):1–29. DOI: http://dx.doi.org/10.15585/mmwr.ss6907a1
Niinimäki, M., Pouta, A., Bloigu, A., Gissler, M., Hemminki, E., Suhonen, S., & Heikinheimo, O. (2009). Immediate complications after medical compared with surgical termination of pregnancy. Obstetrics and gynecology, 114(4), 795–804. https://doi.org/10.1097/AOG.0b013e3181b5ccf9