Analysis-In US Abortion Pill Case, FDA Could Soften Blow Of Court-ordered Restrictions

A conservative federal judge in Texas could soon order the U.S. Food and Drug Administration to reconsider its 22-year-old approval for a pill used in the most common form of abortion in the United States, or order the approval revoked outright.

Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process.

The FDA declined to comment on the litigation or its next steps. But interviews with nine U.S. food and drug law scholars and attorneys, including six who signed onto a brief filed in the Texas case, revealed the agency has the power to delay or soften the blow of a court-ordered ban on the drug or reconsideration of its approval.

Any ruling in the case is expected to be appealed. Even if higher courts upheld a decision against the FDA, the agency could help prevent mifepristone from being immediately withdrawn from the market, these experts said.

Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said.

Mifepristone is part of a two-drug regimen with misoprostol that accounts for more than half of U.S. abortions.

The agency's role in determining mifepristone's future has gotten little notice in a court battle that has drawn widespread attention as the most consequential abortion case since the U.S. Supreme Court last year overturned the 1973 Roe v. Wade ruling that established federal abortion rights.

At a hearing last week in Amarillo, Texas, anti-abortion groups asked U.S. District Judge Matthew Kacsmaryk to halt sales of mifepristone nationwide - even in states where abortion is legal - while their lawsuit against the FDA proceeds.

The groups contend the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug's safety when used by girls under age 18. The FDA said the pill was deemed safe after extensive studies and use, and that the challenge comes much too late.

What happens next will depend on whether Kacsmaryk finds he has the authority to overrule the FDA's decision.

POSSIBLE OUTCOMES

If Kacsmaryk orders the FDA to reconsider the drug's approval, that could trigger a years-long process during which the pill would remain legally available.

Under FDA statutes and regulations, drug approval withdrawal generally begins with an informal hearing, which can entail extensive document preparation and the convening of an advisory committee.

The process is often triggered by post-approval studies showing inefficacy, according to Harvard Law professor I. Glenn Cohen.

That was the case in 2019 with Makena, a pre-term birth prevention drug. The manufacturer protested the FDA's action and subsequent administrative hearings dragged out, allowing Makena to be sold for more than three years before the drugmaker took it off the market this month.

Mifepristone makers also would likely challenge a withdrawal under this process, and the FDA could decide at the end not to remove the drug's approval, said Greer Donley, an associate professor at the University of Pittsburgh Law School.

If the judge takes the more extreme option of ordering mifepristone's approval withdrawn, experts said the FDA would have another countermove: it could choose not to enforce the ban.

That could mean refraining from any action to prevent continued mifepristone sales. Or, the FDA could go further and publicly state it would not take such action.

Some lawyers said the FDA might assert its enforcement discretion under Democratic President Joe Biden's administration, but acknowledged that would elicit political and even legal blowback.

Alta Charo, a University of Wisconsin law professor emerita who was a senior FDA policy adviser during the Obama administration, said she doubted the agency would actively ignore a court decision, in part because U.S. lawmakers could retaliate with measures including budget cuts.

The FDA could also be sued by anti-abortion groups or officials for not enforcing the order, as could mifepristone makers and sellers for continuing to make it available.

Continued access to the pill would depend on how much legal risk manufacturers and sellers were willing to assume, the scholars said.

"If you have the Supreme Court saying that this is an unsafe drug, at that point the legal risks go up enormously, no matter what the FDA does," said Donley.

U.S. mifepristone makers told Reuters their decisions about whether to keep manufacturing the pill would follow the FDA's lead.

Overseas provider Aid Access, an Austria-based service that ships abortion medication to U.S. patients, said it would continue providing the pill no matter how the FDA responds.

Kacsmaryk also is presiding over a lawsuit filed by the anti-vaccine group Children's Health Defense and others accusing media companies, including Reuters, of violating federal antitrust laws by allegedly working with tech companies to censor information about COVID-19. A Reuters spokesperson has denied the allegations.