Court Ruling Leaves FDA Authority in Limbo

While it is critically important for the nation’s healthcare system and for biomedical research that the Supreme Court’s recent ruling preserved access to mifepristone (Mifeprex) for now, the emergency action fails to ensure FDA’s long-standing regulatory authority and legal status for evaluating and approving new drugs and medical products. In sending the case back to the Fifth Circuit Court of Appeals for further review, the high court’s April 21, 2023 action leaves open the prospect of further rulings that could undermine FDA’s approval process. States where abortion remains legal are stocking up on the pills, and biopharma companies are filing briefs to support FDA’s authority to regulate the development of safe and effective medicines.

The case arises from a ruling by Texas federal judge Matthew Kacsmaryk that supports a lawsuit from abortion opponents claiming that FDA’s approval of mifepristone ignored demonstrated safety concerns and relied on “unsound reasoning and studies” in the face of “significant political pressure” to increase access to chemical abortions. The lawsuit also states that FDA overstepped its authority in expanding access to mifepristone in 2016 and January 2023 by moderating distribution restrictions imposed by a Risk Evaluation and Mitigation Strategy (REMS).

The Justice Department, acting for FDA, and manufacturer Danco Laboratories appealed the Texas case to the Fifth Circuit Court of Appeals, which ruled more narrowly that mifepristone could remain on the market, but only under its more limited original prescribing and dispensing conditions in effect until 2016. That decision also threatened access to a recently approved generic alternative from GenBioPro, raising tricky questions about whether a generic drug can remain on the market under conditions that differ from the original brand.

Complicating the situation was a decision in another case from a federal judge in Washington state that mifepristone is safe and effective and that FDA must maintain access to the drug in the 17 states and the District of Columbia backing the lawsuit. Here the court ruled that FDA erred in imposing REMS limits on prescribing and dispensing of the treatment and ordered federal authorities not to make any changes to restrict access to the drug.

In response to the circuit court ruling on the Texas case, the Biden administration and Danco filed an emergency appeal with the Supreme Court on April 14, 2023 to maintain approval of the drug while the case proceeds. The plaintiffs argued 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. Multiple interested parties filed amicus briefs, including members of Congress, physicians, abortion rights groups, and opponents. Pharma and biotech companies railed against this “unprecedented assault on FDA’s approval decisions.”

Woodcock predicts chaos

In a declaration accompanying the FDA appeal to the Supreme Court, Deputy Commissioner Janet Woodcock attested to the harm and difficulties that would arise from a court decision that rescinds the conditions of use for mifepristone approved by the agency in 2016. Such a move would “create significant chaos” for FDA and manufacturers, Woodcock stated, emphasizing that it was a mistake to think that the agency “could simply snap back” to a prior approval situation. Manufacturers would need to revise product labeling, prescribing information, and other documents to reflect new dosing, which now would be out of date.

Here, Justice Samuel Alito disagrees, arguing in a four-page dissent that the high court should have left in place the pre-2016 restrictions on access to mifepristone as ordered by the appeals court. Alito claims that it would not cause “irreparable harm,” as FDA predicts, to limit the drug’s distribution to rules adopted in 2000 because, as he remarkably says, the agency could use its “enforcement discretion” to permit continued marketing of the drug even with outdated labeling while the legal appeals proceeded.

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 the drug regulatory process to allegations of violative behavior on all sides—faulty preclinical and clinical studies, newly detected side effects, and errors in FDA decisions. 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 Fifth Circuit Court has scheduled an expedited hearing on the case for May 17, 2023 to review the merits of the Texas district court decision, particularly on-line and mail-order access to the drug. Many legal experts say the case should be tossed because the antiabortion doctors challenging FDA’s approval of mifepristone lack standing to bring the case. But whoever loses will appeal to the high court, where the outcome remains uncertain.

About the author

Jill Wechsler is Washington editor for Pharmaceutical Technology^®.