Texas abortion pill ruling could undermine U.S. FDA, experts say

A federal judge’s decision last week to suspend the U.S. Food and Drug Administration’s (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said.

U.S. District Judge Matthew Kacsmaryk’s ruling on Friday, which followed a March 15 hearing, was a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues in the Northern District of Texas.

The FDA approved mifepristone, part of a two-drug regimen that accounts for more than half of U.S. abortions, over 20 years ago.

Banning its sale calls into question the FDA’s power to regulate all drugs nationwide, the experts said.

Some said it could also lead drugmakers to stick to treatments perceived as safe investments and shy away from those that might get caught up in politically charged legal cases.

“If that decision were to stand, it would really result in pharmaceutical manufacturers investing less and trying to focus their efforts on drugs that are viewed as a safer bet. It really is potentially a public health disaster,” said Scott Lassman, a lawyer with 30 years of experience in FDA law and policy.

Lawyers, analysts, industry groups, and the government say a ruling against the FDA’s approval of a drug over 20 years earlier is unprecedented and – if it stands after going through the appeals process – could ripple through drug research and development for years, with implications for public health and access to new treatments.

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Any impact on the FDA will depend on details of the judge’s final ruling on the merits of the challenge in the case known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA’s mifepristone approval before Kacsmaryk, who is himself a conservative former Christian activist.

Kacsmaryk ordered mifepristone pulled from the market while he considers a final ruling, but stayed the order for a week in order to give the government a chance to file an emergency appeal, which it did.

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When the case is resolved, that could become a permanent ban, though it is not clear how long that might take, and any ruling is also expected to be appealed.

Should the court ban mifepristone sales based on a finding that it is not safe, a strong possibility after Kacsmaryk said in his Friday ruling that the FDA had ignored risks in approving the drug, that would effectively end the FDA’s status as the ultimate arbiter on drug safety, experts said.

“That would have much bigger implications for other drugs and probably would shake up pharma’s ability to rely on the FDA and feel secure when they submit something, if a court can overrule the FDA’s findings on safety,” said Laurie Sobel, associate director for Women’s Health Policy at the Kaiser Family Foundation.

Plaintiffs are arguing that the FDA in its 2000 approval did not adequately consider the drug’s safety when used by girls under age 18 to terminate a pregnancy.

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Leading industry groups the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) both said the FDA is and should remain the authority on determining drug safety.

U.S Health Secretary Xavier Becerra told CNN on Sunday the court’s decision on Friday was reckless and warned it would have far reaching ramifications.

Even if Kacsmaryk does not address safety and bans mifepristone after finding that the FDA did not follow proper procedures, that would still undermine confidence in the agency.

The possibility of its approvals being overruled would likely see the FDA become more cautious, said Susan Lee, a partner in Goodwin’s Life Sciences group and FDA practice.

The increased scrutiny would make it more difficult and time-consuming to get products approved, and possibly more expensive to develop.

“There’s going to be so much uncertainty about what would happen even if you were to achieve approval in the first place,” said Lee. “There could be a downstream impact on pricing.”

There would also be an impact on what kinds of drugs get made said Lassman, as drugmakers are confronted with a “whole other level of risk” in an already long, expensive, and risky drug development process.

A ruling against the FDA is likely to spur increased activism and lobbying from organizations opposed to other drugs or medical treatments, such as COVID-19 vaccines, contraceptives, hormones for artificial reproductive technology or gender affirming procedures, and HIV prevention drugs.

Similar challenges in front of hand-picked sympathetic judges could lead to other reversed approvals, Lassman warned.

“I think this is a precursor of where the courts are heading,” he said. “It could signal that they’re going to give FDA scientific decisions little or no deference in the future.”