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.
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