04.12.23 (PRESS RELEASE) — Ahead of the 5th Circuit’s decision in Alliance for Hippocratic Medicine v. FDA, 650 individuals, companies, and groups filed briefs urging the appellate court to grant an emergency stay of an outrageous and meritless ruling by Judge Matthew Kacsmaryk. The ruling, issued last Friday night, attempts to undo the approval of mifepristone, a medication that has been safely used by more than 5 million people in the United States since its approval over 20 years ago and that is currently used in more than 50% of abortions. Amici included a diverse array of public health experts, pharmaceutical companies, scientists, cities and states where abortion is protected, and current and former government officials.
A court has never ordered the FDA to take a medication off the market. If allowed to take effect, the ruling could block the use of the drug for medication abortion and miscarriage care nationwide – even in states where abortion remains legal – and disrupt the FDA’s process for approving essential drugs. This attack isn’t about mifepristone’s safety. Instead, it is a transparent attempt by anti-abortion activists to use the judicial system to ban abortion nationwide.
“[R]egulatory flexibility and respect for FDA’s scientific judgment are crucial to fostering the development of new and innovative drugs. The district court’s decision will shatter FDA’s ‘gold standard’ of review,” said an amicus brief by pharmaceutical companies, pharmaceutical company executives, and industry investors, including Pfizer Inc., Gilead Sciences, Inc., and Biotechnology Innovation Organization. “FDA has exercised this critical flexibility in approving thousands of drugs, including numerous transformative medicines. Had those drugs been developed or reviewed by FDA under the district court’s groundless approach, it is unlikely that a single one would have been approved—or that their approvals would have gone unchallenged—and countless patients would have suffered needlessly.”
“Without any form of the evidentiary hearing and in complete disregard to the overwhelming body of evidence proving that mifepristone is safe, the District Court’s order purports to suspend the use of treatment essential to amici’s patients, in order to further its own ideological agenda and that of Appellees,” American College of Obstetricians and Gynecologists (ACOG), American Medical Association (AMA) and 10 other medical and health organizations. “The decision is rife with medically inappropriate assumptions and terminology. It disregards decades of unambiguous analysis supporting the use of mifepristone in miscarriage and abortion care. It relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.”
“The trial court’s order is the first time that any court has second-guessed FDA’s determination that a drug is safe and effective,” said former FDA officials in their brief.
Over 300 members of Congress also weighed in on the case with 240 Democrats urging the court in an amicus brief to keep mifepristone available and 69 Republicans siding with plaintiffs in the case.
“The district court’s order undermines the well-established statutory and regulatory framework for the approval of new drugs and the due process generally accorded to drug marketing application holders by statute. Its perilous consequences reach far beyond mifepristone,” said members of Congress in support of the FDA. “Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions, including asthma, HIV, infertility, heart disease, diabetes, and more.”
“The FDA approved mifepristone over twenty years ago in recognition of the fact that it is safe, effective, and medically necessary. This evidence is even more compelling today, as decades of study and practice have confirmed mifepristone’s efficacy and safety,” commented over 100 reproductive health, rights, and justice advocates in their amicus brief. “The district court’s decision, relying on self-serving anecdotal data and debunked expert testimony, flies in the face of both this conclusive and rigorous scientific evidence and the proper role of a district court reviewing agency decision-making.”
As harmful as the effects will be for abortion and miscarriage care, the implications of this case go far beyond that. Anyone opposed to a medication or vaccine could be emboldened to find a single judge who, with a stroke of a pen, could deny people access to critical life-saving treatments nationwide. That possibility should have everyone in the country very concerned.
You can find more on the amicus briefs here.
Planned Parenthood Federation of America: [email protected]
NARAL Pro-Choice America: [email protected]
American Civil Liberties Union: [email protected]
Center for Reproductive Rights: [email protected]