For the FDA and the pharmaceutical industry, the legal battle over mifepristone casts a shadow over all drugs, medical devices and diagnostics that the agency approves. If the 5th Circuit’s decision is upheld, industry and former government officials say, it would undercut the FDA’s stature as the global gold standard of regulating medicine – as well as the ability of drugmakers to raise money from investors. That, in turn, could deprive patients of innovative therapies.
Pharmaceutical companies denied approval for a drug could use the courts to reverse the agency’s scientific judgements – or challenge the approval of a competitor’s drug, former FDA commissioners said in a brief to the high court. Advocates for patients who suffer side effects from a drug could ask judges to bar other patients from taking an otherwise safe and effective medication.
A brief signed by hundreds of biotech executives said allowing a court to override FDA’s process for approving drugs “will create intolerable risks and undermine the incentives for investment regardless of the drug at issue.”
A group of former Trump-era Department of Health and Human Services officials, however, sided with the challengers in a separate brief that says the FDA failed to properly assess the broader effects of lifting restrictions on mifepristone. James R. Lawrence III, an FDA chief counsel under President Donald Trump, said a ruling in favor of the agency could embolden other drug makers to demand fewer restrictions.
A ruling against the FDA also could broaden who can sue the agency. In the mifepristone case, the four doctors suing the FDA claimed they had legal standing not because their patients were directly harmed by the drug, but because women suffering adverse effects crowding into emergency rooms would take away resources needed to treat other patients.
“Basically, any physician could sue the agency over any drug approval they disagree with,” said Holly Fernandez Lynch, an attorney and assistant professor of health policy at the Perelman School of Medicine at the University of Pennsylvania.
