If there’s one thing a wide swath of industry players can agree on, it’s that the FDA’s drug approval process represents the gold standard for drug regulation.
But if an appeals court’s August ruling on the abortion pill mifepristone holds up, the agency’s decision-making power could be undermined by the courts.
That's the argument made by the influential trade group—plus hundreds of companies, leaders and investors—in amicus brief filings at the Supreme Court. They're urging the court to reverse the ruling and back the FDA's long-standing authority.
Previously, mifepristone’s manufacturer Danco Laboratories, the Department of Justice (DOJ) and several states pressed the Supreme Court to take up the case. Now, the wider biopharmaceutical industry has joined in to back (PDF) Danco.
In the mifepristone case, an appeals court this summer moved to revoke the FDA’s approval for the drug to be distributed by mail. It also shrank the timeframe the drug can be used during pregnancy—from 10 weeks to 7 weeks.
In making its decision, the panel of judges agreed with the plaintiffs, the Alliance for Hippocratic Medicine, that the FDA’s approval process for the med was flawed and exceeded its authority.
Leaving the ruling in place could upend the regulatory process and open the door to lawsuits questioning virtually any approved drug on the market, the industry players argued. As PhRMA puts it in an amicus brief (PDF), the FDA’s regulatory decisions would become “mere precursors to litigation, rather than durable decisions that protect a company’s massive investment in the product’s lengthy research and development process.”
The investments pharmaceutical companies commit to push a drug to approval all rely on the stability of the FDA’s approval process, PhRMA argues.
If the Supreme Court doesn’t overturn the ruling, medicines that patients nationwide have relied on for years could be subject to unexpected changes, wrote attorneys in the second amicus brief, which was cosigned by 19 pages worth of industry players.
“This is not a case where review can wait,” the filing said, urging the Supreme Court to hear the case and reverse the judgment.
Danco asked the Supreme Court to review the case last month, just over a year after the court overturned the landmark Roe v. Wade and left abortion rights across the country unprotected.