FDA Regulatory Authority Under Attack

In an unprecedented ruling, last week a federal judge in Texas suspended FDA’s approval of mifepristone (Mifeprex), declaring that the agency had not sufficiently assessed the safety and efficacy of this widely used abortifacient. Judge Matthew Kacsmaryk stated that FDA ignored demonstrated safety concerns and relied on “unsound reasoning and studies” in the face of “significant political pressure” to increase access to chemical abortions. FDA approved the drug 20 years ago.

If the decision is not overturned, it not only would lead to the removal of the drug from the market across the nation, but it would also raise uncertainties about the continued marketing of any authorized medical product that raises social, cultural, or political issues.

At the same time, a federal judge in Washington state ruled in another case that mifepristone is safe and effective and ordered FDA to maintain access to the drug in the 17 states and the District of Columbia backing the lawsuit. Here Judge Thomas Rice ordered federal authorities not to make any changes to restrict access to the drug in response to claims filed by that state’s attorney general and colleagues that FDA had imposed too many restrictions on patient use of mifepristone.

Similarly, Biden administration lawyers maintain that FDA approval of the drug is based on studies demonstrating that mifepristone is safe and effective and that halting its distribution would harm patients. The Justice Department and drug manufacturer Danco Laboratories filed a notice of appeal, with Attorney General Merrick Garland indicating plans to ask the US Court of Appeals for the 5th circuit to allow FDA to maintain approval of the drug while the case proceeds. Implementation of the Texas ruling was delayed for seven days to accommodate such anticipated challenges and court-ordered delays.

FDA posted a statement on Twitter that it “stands behind its determination that mifepristone is safe and effective under its approved conditions for use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses." The agency adds that the drug was approved based on the “best available science and done in accordance with the laws that govern our work.”

Ignoring science

The broader issue for industry, policy makers, and legal experts is whether FDA approval and marketing decisions can be overturned by private lawsuits on the basis of alleged safety issues that surface post-approval. If such a ruling is successful, it could open up the drug regulatory process to allegations of violative behavior related to a range of perceived situations—faulty preclinical and clinical studies, newly detected side effects, and violations in the FDA decision-making process. In the past, courts have shied away from making such rulings based on their recognition that the technical and scientific aspects of drug regulation are complex and need to be decided by experts.

The Texas lawsuit also claims that FDA overstepped its authority in expanding access to mifepristone in January 2023 by moderating distribution restrictions imposed by a Risk Evaluation and Mitigation Strategy (REMS). Conversely, the main claim in the Washington state suit is that FDA erred in imposing REMS limits on prescribing and dispensing the treatment.

Analysts on all sides expect the issue to be addressed by the Supreme Court, which now faces two conflicting federal court rulings. But how quickly and on what grounds the high court will move on these cases remains to be seen. Meanwhile, legal authorities and public health experts will be examining the court decisions closely as well as the details raised related to the history of FDA approval decisions. A summary of the issues and options are outlined in a brief developed by health policy experts at the Kaiser Family Foundation.

One immediate effect of these legal developments may be a shift to less safe and effective medical abortions. Clinics that provide such services may be forced to shift to chemical procedures that use only the second drug, misoprostol, a widely available stomach ulcer drug that is currently prescribed to be taken after mifepristone to fully expel the embryo or fetus from the patient. Medical abortions are considered more safe and effective with the two-drug regimen, but clinics in many part of the world have long used only misoprostol, despite its more harmful side effects.

Experts familiar with the drug approval process fear that such court challenges to FDA’s oversight authority could open the door for multiple lawsuits to block agency decisions on all sides (i.e., new drug approvals, perhaps by competitor firms; limits on access to vaccines; curbs on blood donor requirements; approval of therapies that raise social, cultural, or economic issues). The situation speaks to the need for the biomedical research community and developers of critical medical products to question such threats to future access to treatment and voice support for science-based regulation.

About the author

Jill Wechsler is Washington editor for BioPharm International.