Texas abortion pill ruling could disrupt U.S. drug oversight

[April 06, 2023]  By Ahmed Aboulenein

WASHINGTON (Reuters) - A federal judge in Texas could soon order the U.S. Food and Drug Administration to withdraw its approval of abortion pill mifepristone, a move that if allowed to stand could severely undermine the agency, health policy and legal experts said.

The closely followed case could potentially lead to a nationwide ban on mifepristone - part of a two-drug regimen that accounts for more than half of U.S. abortions - and call into question the FDA's power to regulate all drugs nationwide, they said.

It also risks leading to self-censure by the pharmaceutical industry as drugmakers embrace treatments perceived as safe investments and shy away from those that might get caught up in politically charged legal entanglements, some experts cautioned.

"This case potentially has very significant consequences for both products that are already on the market, as well as new products," said Susan Lee, a partner in Goodwin's Life Sciences group and FDA practice. "The potential implications are so much broader than just what could happen to mifepristone."

A ruling against the agency's approval of a drug over 20 years earlier would be unprecedented and could ripple through drug research and development for years, with implications for public health and access to new treatments.

Any impact on the FDA will depend on details of the judge's ruling 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 U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas, a conservative former Christian activist.

The court could order mifepristone pulled from the market while it considers a final ruling. 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 expected to be appealed.

If it finds the FDA did not follow proper procedures, that would undermine confidence in the agency and likely lead it to adopt more stringent regulations, some experts suggested.

Should the court ban mifepristone sales based on a finding that it's not safe, that would effectively end the FDA's status as the ultimate arbiter on drug safety, experts said.

Used boxes of Mifepristone pills, the first drug used in a medical abortion, fill a trash at Alamo Women's Clinic in Albuquerque, New Mexico, U.S., January 11, 2023. REUTERS/Evleyn Hockstein

It would call into question the entire drug approval process, said Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation.

"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," Sobel said.

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.

'SO MUCH UNCERTAINTY'

The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said.

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."

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, Lee warned.

"If you can have somebody come in successfully challenging an approval that was more than 20 years ago," she said, "there's very little comfort that any manufacturer could take in their approval."

(Reporting by Ahmed Aboulenein; Editing by Caroline Humer and Bill Berkrot)

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