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Mifepristone and the Legitimacy of the FDA

The unprecedented ruling by a federal court in Texas that the FDA’s approval of the abortifacient drug mifepristone is analyzed in a Viewpoint article.

The legal standing of the plaintiffs could be the legal point on which this case turns. “The physicians’ highly attenuated claims of harm would mean that any physician could sue about any drug, even if they have nothing to do with that drug, because medical complications are always possible, even if the complication rate is as low as mifepristone’s,” writes the author. “Their argument that they can sue so many years later also would discourage the FDA and drug companies from making beneficial adjustments to a drug’s instructions or label. There is no claim the FDA reopened review of mifepristone’s initial approval when it adjusted the REMS; to the contrary, the drug was so safe, it lifted restrictions. If allowed to go forward, this lawsuit therefore paves the path to potentially incessant challenges to any drug. Such challenges would destabilize and politicize the drug market and lead to massive uncertainty for drug manufacturers, which would in turn almost certainly increase drug costs for most drugs, not just drugs such as mifepristone or Viagra.”

The author concludes: “The Biden administration has pledged to vigorously defend the FDA and the legitimacy and political independence of its process. Thanks to the Supreme Court, the drug remains available during the pendency of the appeals, which will first occur in the intermediate federal court, the Fifth Circuit, and then likely wind up in the Supreme Court itself.”

Source: JAMA