Advocates submitted a letter to the FDA affirming the safety record of mifepristone. The letter was submitted by the Advancing New Standards in Reproductive Health at UCSF and 260 researchers. They seek to ensure that the FDA follows "transparent, rigorous science" in any decisions about Mifepristone. An excerpt is below:
Decades of conclusive scientific evidence amassed through more than one hundred rigorous studies based on hundreds of thousands of patient outcomes have overwhelmingly established the safety and effectiveness of mifepristone for medication abortion and management of early pregnancy loss. The FDA has reviewed that large and sound body of science at many junctures over the past 25 years and, at each moment, confirmed the safety and effectiveness of mifepristone generally and, time and time again, the FDA has found complications and serious adverse events associated with mifepristone extremely rare. Based on this body of evidence, the FDA has modified mifepristone labeling, and eased specific REMS restrictions when science proved they were unnecessary to protect patient safety and unduly restricted access.
* * * We strongly believe that the lynchpin of sound science is whether the data and methods are transparent, the work is reproducible by other scientists, and the work has been subject to the rigors of unbiased peer review. We are extremely concerned that the FDA may be considering significant action to reverse previous mifepristone REMS and label updates based on unverified and unreliable reports and studies that do not satisfy gold science standards. For the reasons discussed below, significant federal action based on these recent reports, or others that similarly lack scientific rigor and reliability, would be inappropriate and unsound federal agency decision-making.
In support of its recommendation that the FDA reinstate a regulatory protocol from when mifepristone was first approved over 20 years ago, the Ethics and Public Policy Center (EPPC) has self-published two position papers on medication abortion – one on occurrences of serious adverse events and one on the occurrence of failure. In these papers, EPPC presents its findings and conclusions as the product of the “largest-known study of the abortion pill” derived from its “analysis of data from an all-payer insurance. According to EPPC, its mission is “to apply the riches of the Jewish and Christian traditions to contemporary questions of law, culture, and politics” in America. EPPC’s “The Life and Family Initiative,” which produced the recent reports on mifepristone, is “committed both to ensuring the equal protection of unborn children in law and to providing concrete support to families by advancing a pro-life, pro-family agenda that takes our duties in justice to the unborn and to families seriously.” * * * However, as discussed below, these reports lack basic information and disclosures that reputable studies provide for transparency and reproducibility. Moreover, several claimed findings and conclusions appear to be based on errors and/or flawed assumptions drawn from the undisclosed data source and guided by an unnamed research team. Given these serious deficiencies, EPPCs position papers do not credibly call into question, let alone outweigh, the consistent findings from an overwhelming body of rigorous scientific studies and methodologically transparent data demonstrating that mifepristone, including when provided through telehealth, is safe and effective.
In its first self-published report of insurance data for medication abortion prescriptions, EPPC claims that its analysis shows 10.93% of patients experienced “a serious adverse event” after a mifepristone abortion. This purported finding is the foundation of their claim that the “real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as reported on the drug label.” But the report does not provide reliable evidence to support this claim, nor does any published literature.