After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

After last year’s explosive ruling to overturn the historic abortion ruling reached in Roe v. Wade, abortion access is back up for debate in the Supreme Court. This time, the FDA’s power is on the table, too.

The United States' highest court has agreed to review a Fifth Circuit appeals ruling that restricted access to Danco Laboratories’ abortion pill mifepristone and called the FDA’s regulatory authority into question, an order list (PDF) shows.

Specifically, the appeals court's prior ruling cut down the FDA’s approval for the pill to be delivered by mail, a call the agency made after the Supreme Court overturned Roe v. Wade. It also shrank the time frame the med can be used during pregnancy from 10 weeks to 7 weeks.

The Fifth Circuit called the FDA’s approval process for the expanded access flawed and said the agency exceeded its authority. However, the appeals court did dismiss a section of the lawsuit that argued against the FDA’s original 2000 approval and a later generic approval.

The Supreme Court’s verdict is slated for the end of June 2024, NBC News reports. The Court previously allowed the pill to stay on the market as-is while the litigation plays out.

Outside of abortion access, another key issue at play is the regulatory authority of the FDA, industry players have said.

Influential trade group PhRMA argued that if the ruling stands, 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.”

Hundreds of drug companies, leaders and investors also filed amicus briefs urging the court to reserve the appeals ruling and stand behind the FDA’s gold-standard review process, underlining the industry-wide significance of the case.

Meanwhile, the Biden administration has echoed the industry’s concerns. White House press secretary Karine Jean-Pierre noted in a recent statement that the Fifth Circuit decision “threatens to undermine the FDA’s scientific, independent judgment and would reimpose outdated restrictions on access to safe and effective medication abortion.”

“This Administration will continue to stand by FDA’s independent approval and regulation of mifepristone as safe and effective,” Jean-Pierre added.