Law experts argue that abortion drug withdrawal would 'undermine' the approval process
More than a dozen food and drug law experts argued on Wednesday that yanking the medication abortion drug mifepristone from the market would “undermine the drug approval process far beyond the context of mifepristone’s approval.”
The comments are in response to a Texas lawsuit challenging the 2000 approval of mifepristone, which is used in combination with misoprostol to end pregnancies within the first 10 weeks. Nineteen scholars from several universities — including Harvard and Stanford’s law schools — argued in an amicus brief that a preliminary order to withdraw mifepristone’s approval would be “unprecedented and inappropriate.”
“Finally, overriding FDA’s safety and efficacy determination and forcing FDA to withdraw a longstanding drug approval would profoundly undermine the statutory and regulatory framework underpinning the approval of new drugs, thereby threatening patient access to therapeutics and chilling industry research and development,” they wrote.
The amicus, or “friend of the court,” brief was one of six filed on Wednesday, including letters from the nonprofit Doctors for America, Republican attorneys general and Democratic attorneys general.
While the Republican AGs took issue with what they called a “wide-ranging mail-order abortion-drug regime,” Democrats (and one Republican AG) countered that mifepristone has been “particularly critical in providing access to abortion in low-income, underserved, and rural communities where procedural abortion may be unavailable.”
“And because medication abortion is the most common method used to terminate pregnancy during the first trimester, eliminating access to this method will result in more abortions taking place later in pregnancy, further increasing costs and medical risks,” they wrote.
Last month, the FDA urged US District Judge Matthew Kacsmaryk to reject a preliminary injunction requested by abortion opponents, which would require the withdrawal of all mifepristone approvals. Regulators argued that a withdrawal would deprive people of a safe and effective drug.
Medication abortion accounted for more than half of US abortions in 2020, and last month, the FDA approved a modification that allows certain “specially certified” pharmacies to dispense mifepristone. Previously, policies required patients to receive the drug in a clinic, medical office or hospital, though regulators didn’t enforce in-person requirements at certain times during the pandemic.
Upon conducting reviews, the FDA said that “there did not appear to be a difference in adverse events between periods when in-person dispensing was and was not enforced.” The modification applies to both Danco Labs’ brand-name Mifeprex pills and a generic manufactured by GenBioPro.
“Plaintiffs are also incorrect in asserting that FDA approved mifepristone on the basis of inadequate evidence. To the contrary, FDA has conducted multiple full and complete reviews of mifepristone’s safety and efficacy, and each time, it acted properly in determining that the drug meets the approval standards of the FDCA and is appropriately labeled,” the food and drug scholars wrote.