In this articleCVSWBAFollow your favorite stocksCREATE FREE ACCOUNTMifepristone and Misoprostol pills are pictured Wednesday, Oct. 3, 2018, in Skokie, Illinois.Erin Hooley | Chicago Tribune | Tribune News Service | Getty ImagesJust 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.[embedded content]How the FDA could shape accessThe FDA’s approval of Evita’s generic pill marked a rare expansion of the mifepristone market. The agency put out no press release or statement about the approval, a silence Thome and many abortion rights advocates interpreted as an effort to avoid reigniting one of the country’s most polarizing debates.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 —meaning it performs the same way in the body as the brand-name version — the FDA has little discretion to block it, according to the Department of Health and Human Services.”It took the anti-abortion movement a little bit by surprise, but it shouldn’t have. This is the way the FDA is meant to operate,” O’Connor said.Behind the scenes, Trump has appointed FDA officials sympathetic to anti‑abortion groups since returning to office. In May, the agency launched a controversial safety review of mifepristone at the behest of HHS Secretary Robert F. Kennedy Jr. that could lead to tighter telehealth and mail-order restrictions, require in-person doctor prescriptions for the pill or even pull the drug from shelves.The FDA hasn’t detailed the scope or timeline of the review. Some experts have criticized the studies cited to justify the review as methodologically flawed; Laurie Sobel, an associate director for women’s health policy at KFF, told CNBC they are “junk science.”Trump has other levers beyond the FDA if he wants to curb access, experts said.Chief among them is reviving the 19th century Comstock Act — a dormant law prohibiting the mailing of “obscene” materials, including abortion drugs. The Biden administration interpreted it narrowly to allow pill shipments to states where abortion is legal. But the Trump Justice Department could reinterpret the statute more broadly to block the shipments of mifepristone nationwide.Mifepristone has a 25-year safety record for ending pregnancies in the U.S. Since 2021, the FDA has permitted telehealth and mail-order prescriptions, making abortions cheaper and more accessible, particularly for women far from clinics or in states that restricted the procedure after Dobbs v. Jackson Women’s Health Organization, the Supreme Court decision that overturned abortion rights …
