Biotech Group Blasts Reproductive Drug Ruling

(Robin Marty, Flickr. https://flic.kr/p/2dnWDGF)

10 Apr. 2023. A biotechnology industry group calls Friday’s ruling in a Federal district court to suspend approval of the drug mifepristone “an assault on science.” On Friday, Judge Matthew Kacsmaryk in the federal district court in Amarillo, Texas, issued a preliminary injunction reversing the approval in 2000 by the Food and Drug Administration of mifepristone, a drug to terminate pregnancies in the first 10 weeks.

Kacsmaryk also issued a seven-day stay of the injunction to allow time for appeals. That same afternoon, Judge Thomas Rice in the federal district court in Spokane, Washington issued a separate preliminary injunction ordering FDA not to alter “the status quo or rights as it relates to the availability of mifepristone.” The competing orders are expected to end up at the U.S. Supreme Court for resolution.

In a statement the next day, Rachel King, president and CEO of the Biotechnology Innovation Organization or BIO called Kacsmaryk’s ruling, “an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines.” King added, “For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent.” BIO says its membership includes companies, state affiliates, and research labs in 30 countries.

“This decision has ramifications that extend well beyond this case,” King noted, “setting a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies. As this case works its way through the appeals process, it is our hope that this ruling is overturned, so that patients and drug developers can rely on the rigorous FDA approval process as the scientific and trusted standard for drug approvals.”

Risk evaluation and mitigation strategy

In 2000, FDA approved Mifeprex, a branded version of mifepristone made by Danco Laboratories in New York, when used as part of a regimen with the drug misoprostol. Under current guidance, FDA approves using the two-drug regimen within the first 10 weeks of pregnancy. Mifepristone blocks progesterone, a hormone needed to continue pregnancies, while misoprostol induces contractions to remove the fetus. The guidance also calls for a follow-up visit to a health care provider seven to 14 days after taking misoprostol. FDA approved a generic version of mifepristone in 2019.

FDA’s guidance for mifepristone is accompanied by a risk evaluation and mitigation strategy or REMS, a set of guidelines for health care providers prescribing the drug that the agency says is based on experiences of clinicians and users since the initial approval. In Jan. 2023, FDA amended the REMS to remove the need for in-person dispensing of mifepristone and certify pharmacies for distribution, enabling remote sales of the drug.

The Amarillo, Texas decision was made in response to a suit filed by the Alliance for Hippocratic Medicine, a coalition of organizations claiming religious affiliations opposed to abortion. The Spokane, Washington decision was made in response to a contradicting suit filed by attorneys-general in 17 states and the District of Columbia.

As of noon today (10 Apr. 2023), the Pharmaceutical Research and Manufacturers of America, or PhRMA, has not issued a statement on the court decisions. However, Priscilla VanderVeer, vice president of public affairs for the group told the New York Times, “While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to F.D.A.-approved medicines.”

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