ICYMI: Amicus Briefs in Federal Mifepristone Lawsuit Underscore Medication Abortion’s Safety, Potential Cascading Consequences if FDA Approval is Stripped

WASHINGTON — In case you missed it, anti-abortion groups are not satisfied with overturning Roe v. Wade and want to weaponize the court system to dismantle sexual and reproductive health care nationwide. One of their main targets is medication abortion: in Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration, plaintiffs are asking a federal judge to take an unprecedented step and direct the FDA to revoke the 22-year approval of mifepristone, which would effectively amount to a national ban on mifepristone, one of two medications most commonly used in a medication abortion.  

In amicus briefs filed this past Friday, medical providers, scholars, and state attorneys general are pushing back on the false claims made by anti-abortion activists and detailing the potential harm this case presents for patients across the country. 

From the amicus brief by the attorneys general for New York, California, Colorado, Connecticut, Delaware, Hawai‘i, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Washington, And Wisconsin, and the District Of Columbia:

“Given the widespread use of mifepristone, if plaintiffs’ allegations regarding the magnitude of risk associated with medication abortion were accurate, those harmful effects would be impossible to hide at the population level. But amici have seen no such effects—and in fact, the opposite is true.”

“The consequences of annulling the FDA’s approval of medication abortion currently the most common method of obtaining early abortion—would be nothing short of catastrophic, causing shock waves nationwide.”

From American College of Obstetricians and Gynecologists, the American Medical Association, and other medical professionals: 

“Making mifepristone unavailable nationwide—even in states where abortion remains legal—will impose a severe, almost unimaginable cost on pregnant people throughout the United States. 

“Abortion care can be lifesaving, especially for people suffering from serious health conditions or experiencing early pregnancy loss. Medication abortion’s relative availability makes it more accessible to patients who otherwise face challenges to access medical care, including low-income patients and patients of color—the very people who are most likely to experience severe maternal morbidity and more likely to die from pregnancy-related complications. Pregnant people of color are also more likely to experience early pregnancy loss or miscarriage, the treatment for which can include procedural or medication abortion. Enjoining the use of mifepristone would only harm these patients by removing a relatively accessible and entirely safe treatment from the marketplace—resulting in more people being denied requested abortion care.”

From the brief of 19 food and drug law scholars at 16 academic institutions nationwide: 

“We are not aware of any case in which a court has removed a drug from the market over FDA’s objection. 

“The effects could extend far beyond mifepristone. No drug is without risk, and a ruling for Plaintiffs could lead to challenges to FDA’s benefit-risk determinations for drugs it has approved to treat other diseases and conditions. Patients who rely on life-saving medications could see their drugs removed from the market with little notice." 

“Additionally, Plaintiffs’ remedy, if granted, would create widespread uncertainty in the pharmaceutical industry and chill research and development. FDA is the sole U.S. agency with which industry engages on issues related to drug review, approval, and labeling changes. Manufacturers are familiar with the FDCA and FDA’s regulations and procedures, and they invest in clinical research and costly clinical trials against the backdrop of that framework. If courts can unilaterally overturn safety and effectiveness determinations, manufacturers would simultaneously have to navigate a patchwork of judicial decisions regarding what is required for drug approval. This would fundamentally confound the expectations of industry, leave manufacturers vulnerable to challenges to their currently marketed drugs, and discourage investment in research and development of new drugs.”

For more on the ongoing court cases related to sexual and reproductive health care, read this memo. 

For more information or to speak with a Planned Parenthood representative about the consequences of this or other ongoing court cases threatening sexual and reproductive health care, please email [email protected]. 

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