Abortion pill mifepristone access steady under Trump, FDA review looms

Just over a year since Donald Trump was elected president again, the $6.9 billion abortion pill industry is operating under the same federal rules he inherited from former President Joe Biden — but new threats to the drug are mounting.

Between a Food and Drug Administration safety review that could upend distribution, legal battles over whether the pill can stay on the market, and anti-abortion rhetoric from activists and the Trump administration, drugmakers appear to be bracing for a storm that could reshape a profitable corner of the health-care industry.

“When it comes to medication abortion, there haven’t been any major policy changes yet in this administration,” said Katie O’Connor, senior director of federal abortion policy for the National Women’s Law Center. “But, we’ve also seen some signaling from the administration that they’re going to do something.”

For now, the FDA permits the pill, mifepristone, to be prescribed via telehealth and delivered by mail. Certified pharmacies are still dispensing it in about half of U.S. states, depending on state law.

Taken with misoprostol, mifepristone forms the standard two-drug regimen that has been used in the U.S. for more than two decades and accounts for about two-thirds of abortions annually, according to the Guttmacher Institute.

Though Trump and many key anti-abortion advisors have been in power for more than a year, manufacturing of mifepristone hasn’t dropped. And in September, the FDA quietly approved a generic version from Evita Solutions, the first new U.S. producer since 2019, to end pregnancies through 10 weeks.

Yet, analysts like Joe Thome at TD Cowen, who covers the FDA, say there’s more risk to the market and abortion access than it may seem.

Even small shifts in federal rules could ripple across the supply chain from insurance reimbursement systems to telemedicine platforms and pharmacy compliance protocols, particularly for mifepristone makers such as GenBioPro, Evita Solutions and Danco Laboratories.

“If the FDA were to add warning labels or more restrictive limits on treatment, that then can trickle down into policies for payers, Medicaid reimbursement, companies’ production and performance and have implications for actually getting the drug to to patients for at an affordable rate,” Thome said.

Pharmaceutical stocks barely moved on the approval partly because insiders had anticipated it as a regulatory formality, O’Connor said. Under federal law, once a generic drug meets equivalence standards…