February 23, 2024

US court ruling on abortion pill sparks concerns about FDA approvals

In a significant ruling on medication abortion in the United States last week, a three-judge panel from the Court of Appeals for the Fifth Circuit upheld a key portion of a judgment issued earlier this year by a federal judge in Texas.

Judge Matthew J. Kacsmaryk had effectively revoked the FDA’s endorsement of the drug mifepristone, better known as abortion medication. This was appealed.

The nub of the appeals court’s decision, if ratified by the Supreme Court, would be to reverse recent FDA modifications that have significantly broadened the pill’s availability. As a result, women might have to attend three doctor visits to obtain mifepristone and could not receive it through the mail.

Reporting has focused on whether access to medication abortion will be restricted. However, the court was not deliberating the rights and wrongs of abortion, but whether the US Food and Drug Administration (FDA) had acted prudently and legallyu in approving it and in subsequently significantly relaxing restrictions on a potentially dangerous drug.

Most users of the pill would be surprised that the Court believes that the FDA was playing fast and loose with women’s safety:

In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.

Astonishingly, the FDA stopped mandating data collection. It then loosened restrictions because it claimed to be unaware of the existence of adverse events as a result of using the pill. The majority were scathing about this:

The agency is responsible for its own inability to obtain probative data; it cannot then cite its lack of information as an argument in favor of removing further safeguards.

The case is headed toward the US Supreme Court, but it is not clear whether SCOTUS will take it up.