A group of 53 biotech leaders is expressing support for mifepristone in a letter to the FDA, urging the agency not to impose new restrictions on its use as an abortion medication and slamming a "fatally flawed" report fueling recent scrutiny.
The June 30 letter was shared as a comment to a citizen petition in support of mifepristone submitted to the FDA on Feb. 4 by the American College of Obstetricians and Gynecologists, the Society of Family Planning and the Society for Maternal-Fetal Medicine.
The lead signatory of the letter is Grace Colón, Ph.D., the CEO and co-founder of cardiopulmonary startup Inaya Therapeutics. Other notable signatures come from Recode Therapeutics CEO Shehnaaz Suliman, M.D.; Sena Therapeutics Executive Chair Julia Owens, Ph.D.; Nkarta CEO Paul Hastings; and Alnylam's founding CEO John Maraganore, Ph.D.
The letter centers on an April article from the Ethics and Public Policy Center (EPPC), an anti-abortion conservative think tank, claiming mifepristone is harmful to women. The group declares that 1 in 10 women taking mifepristone experience a serious adverse event and that the pill has a failure rate of at least 5.26%, requiring many patients to attempt abortion multiple times. The think tank has not yet provided a data set to back up the claims.
FDA Commissioner Martin Makary, M.D., announced plans to review the safety of the abortion pill in June after pressure from Sen. Josh Hawley, R-Mo., based on the EPPC report.
“The EPPC report is fundamentally, fatally flawed,” the biotech leaders wrote in their letter. “It was not reviewed in the standard scientific vetting process. To date, the dataset has not been made available to researchers in the field.”
The authors also declared the report is riddled with methodological flaws, like counting emergency room visits as serious adverse events, “contradicting FDA guidance and exaggerating the number of adverse events associated with mifepristone.”
Mifepristone is a highly studied medication, with more than 100 peer-reviewed studies demonstrating its safety and efficacy, the biotech leaders wrote. Risks are similar to that of commonly prescribed antibiotics and over-the-counter NSAIDs. The FDA’s own website notes that mifepristone is safe and was approved “more than 20 years ago based on a thorough and comprehensive review of the scientific evidence.”
“The FDA has never relied on publications with such unreliable methodologies,” the authors wrote about the EPPC document. “We urge the FDA to continue its tradition of following rigorous scientific evaluations as the sole basis for determining the ongoing safety and effectiveness of approved medicines.”
Allowing unreliable information would "pave the way for any political or interest group to undermine well-grounded FDA decisions with baseless claims," the biotech executives and investors said. "The resulting regulatory uncertainty could destabilize the drug approval process, chill drug development and innovation and compromise patient health."
Makary’s June announcement almost immediately sparked another citizen petition, this one from the states of Massachusetts, New York, New Jersey and California, which echoed the earlier petition in calling on the agency to remove the mifepristone Risk Evaluation and Mitigation Strategy (REMS) program and not place any new restrictions on access to the pill. The REMS program limits who can prescribe mifepristone and under what circumstances.