The attorneys general of New York, California, Massachusetts, and New Jersey on Thursday asked the US Food and Drug Administration (FDA) to remove some of the restrictions on access to mifepristone, the so-called “abortion pill.” The four states have requested that the FDA remove the mifepristone risk evaluation and mitigation strategies (REMS) program, “including but not limited to the Prescriber Certification, Pharmacy Certification, and Patient Agreement form.” The states have dubbed these requirements “unnecessary, duplicative, and burdensome.”
The FDA approved mifepristone (brand name “Mifeprex”) more than 20 years ago based on a comprehensive review of scientific evidence. As of 2016, mifepristone has been deemed safe for use of medical termination of pregnancy up to 70 days of gestation. During the COVID-19 pandemic, the public saw great changes to the availability of mifepristone, specifically the ability to receive the pill in the mail for eligible patients. However, the FDA retained all other risk evaluation and mitigation strategies during this time.
In determining whether a REMS protocol is necessary for a certain drug, the FDA assesses whether “the benefits of the medication outweigh its risks.” Not all drugs mandate REMS. For mifepristone specifically, the FDA has determined that a REMS initiative is obligatory:
The Mifepristone REMS Program is intended to mitigate the risk of serious complications associated with mifepristone when used for medical termination of pregnancy through ten weeks gestation by, among other things, requiring that prescribers have the necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.
The petition of the attorneys general states that mifepristone’s “associated” fatality rate is a mere 0.00048 percent for the 25 years it has been on the US market, and none of those deaths can causally be attributed to mifepristone because of other confounding factors—such as concurrent use of other drugs, surgical treatments, and other medical conditions and personal factors. The four states contend that even with the loosening of mifepristone’s restrictions over the years, its safety has remained “stable” and that even the FDA has acknowledged that the pill may be safer than procedural abortions for some. The attorneys general state that the current REMS requirements, which mandate that patients “sign an agreement form” and that providers and pharmacies “obtain special certification,” are not related to any “specific risk” of the drug. The petitioners further argue that the FDA is inappropriately meddling in decisions that are “best left to physicians and other licensed clinicians.”
Amidst the Trump administration’s crackdown on reproductive health, Attorney General Letitia James recently led a coalition of 19 other attorneys general in urging the American Medical Association to protect health care providers from cumbersome certification requirements, particularly as it pertains to abortion and gender-affirming care.
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