Federal rules on the abortion pill mifepristone remain unchanged a year after President Donald Trump’s election, but an FDA safety review has stirred new uncertainty.
State enforcement and lawsuits are reshaping access and liability across a $6.9 billion abortion drugs market in the U.S., which is reliant on telehealth and mail delivery.
Drugmakers including Danco Laboratories and GenBioPro have expanded into miscarriage and hormonal therapy markets.
Mifepristone and Misoprostol pills are pictured Wednesday, Oct. 3, 2018, in Skokie, Illinois.
Erin Hooley | Chicago Tribune | Tribune News Service | Getty Images
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.
How the FDA could shape access
The 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 enshrined in Roe v. Wade.
Meanwhile, pharmacies like CVS and Walgreens haven’t stopped prescribing mifepristone in legal states, though both maintain strict controls to limit liability.
“The more that these drugs are stigmatized, the more that the pharmacies themselves risk becoming stigmatized simply by providing the drugs,” said R. Alta Charo, a professor emerita of law and bioethics at the University of Wisconsin at Madison, said. “At some point these pharmacies may say we don’t want to get involved in that, and they may just decide not to stock the drug.”
However, Costco announced in August that it would not sell mifepristone in its stores’ pharmacies citing low demand from members and other patient customers.
Dr. Franz Theard watches a patient take mifepristone, the first medication in a medical abortion, at Women’s Reproductive Clinic of New Mexico, in Santa Teresa, January 13, 2023.
Evelyn Hockstein | Reuters
How drugmakers are responding
Inside the industry, drugmakers like Danco Laboratories, GenBioPro and Evita Solutions appear to be taking steps that would likely cushion the blow of any crackdown on mifepristone.
Danco Laboratories is seeking FDA approval to expand mifepristone’s approved use to include miscarriage management, The Wall Street Journal first reported. Evita and GenBioPro are also exploring new hormonal therapy products.
“Companies don’t always pursue a formal regulatory approval for a secondary or tertiary use, because to do that, you have to go through another set of clinical trials that’s incredibly expensive,” Charo said. “But, if they do it, then they get an advantage.
GenBioPro also remains embroiled in a lawsuit against the FDA and the state of West Virginia from 2023, arguing that the state’s ban on mifepristone conflicts with the federal approval authority, a concept known as “federal preemption.” The case remains under appeal but more litigation would likely follow suit should future federal directives curb telehealth access to mifepristone.
“There’s been a lot of litigation around mifepristone in the last few years, and there’s a lot of uneasiness by pharmaceutical companies of a court telling the FDA how to act,” Caroline Sacerdote, a litigator at the Center for Reproductive Rights, told CNBC. “That’s not the protocol.”
Misoprostol, one of the two drugs used in a medication abortion, is displayed at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.
Robyn Beck | AFP | Getty Images
State-level differences in abortion pill access
As drugmakers take stock of potential federal changes, they have to navigate a wide range of state policies.
The number of abortions in states with total bans or early gestational limits saw sharp drops immediately after the Supreme Court’s 2022 Dobbs ruling, but have seen a slight decline since Trump took office, according to the Guttmacher Institute. Nationwide, the number of abortions rose in 2023 and 2024 even with bans on the surgical procedure in a dozen states.
No state has enacted a new medication abortion ban since Trump’s election. In fact, voters in seven states approved ballot measures to protect abortion rights, often by enshrining them in their state constitutions. However, in a few states, enforcement of preexisting abortion bans has hardened.
Texas, Louisiana and Idaho have expanded penalties for mailing abortion pills, while Texas’s “bounty-hunter law” allows private citizens to sue anyone who helps facilitate an illegal abortion — even by advising or mailing pills.
Those measures are subject to a number of ongoing lawsuits. Still, bans on mail-order pills have proven difficult to carry out, Charo said. The U.S. Postal Service doesn’t proactively help states enforce bans or screen mail for pills, and federal law dictates what the USPS can or will do, making it nearly impossible for state authorities to intercept packages without federal assistance.
Even so, simply the possibility of legal action has had a chilling effect on providers who are afraid to prescribe mifepristone, via telehealth or through the mail, to patients across state lines where the medicine is legal but surgical abortion is not.
“Louisiana has indicted a doctor in New York for providing telehealth medication abortion to someone in Louisiana. Texas has sued a doctor in New York for for doing the same thing,” O’Connor said. “That in and of itself, it has a really serious chilling effect on doctors feeling as comfortable prescribing.”
Meanwhile, states like California and New York have strengthened “shield laws” that protect providers treating out-of-state patients. Even so, funding cuts, staff shortages and surging out-of-state demand have forced some clinics to shutter.
“Regardless of whether abortion is legal, clinics are struggling to stay open,” Sobel with KFF said. “The Big Beautiful Bill has cut funding for Planned Parenthood and funding for other family planning … It’s also the restrictions on federal funding that are impacting the ability for clinics that regularly see Medicaid patients too.” More
