Mifepristone and misoprostol pills are shown on Wednesday, Oct. 3, 2018, in Skokie, Illinois.
Erin Hooley | Chicago Tribune | Tribune news service | fake images
Just over a year after Donald Trump was re-elected president, the $6.9 billion abortion pill industry operates under the same federal rules it inherited from former President Joe Biden, but new threats to the drug are mounting.
Between a Food and Drug Administration safety review that could disrupt distribution, legal battles over whether the pill can remain 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 healthcare industry.
“When it comes to medication abortion, there hasn't been any major policy change yet in this administration,” said Katie O'Connor, senior director of federal abortion policy at the National Women's Law Center. “But we've also seen some signs from the administration that they're going to do something.”
For now, the FDA allows the pill, mifepristone, to be prescribed via telehealth and delivered by mail. Certified pharmacies still dispense it in about half of U.S. states, according to state law.
Taken with misoprostol, mifepristone forms the standard two-drug regimen that has been used in the United States for more than two decades and accounts for about two-thirds of annual abortions, according to the Guttmacher Institute.
Although Trump and many key anti-abortion advisers have been in power for more than a year, mifepristone production has not slowed. And in September, the FDA quietly approved a generic version from Evita Solutions, the first new U.S. producer since 2019, to terminate pregnancies up to 10 weeks.
However, analysts such as Joe Thome in TD Cowencovered by the FDA, they say there are more risks to the abortion market and access than meets the eye.
Even small changes to federal regulations could affect the entire supply chain, from insurance reimbursement systems to telemedicine platforms to pharmacy compliance protocols, particularly for mifepristone manufacturers such as GenBioPro, Evita Solutions, and Danco Laboratories.
“If the FDA were to add warning labels or more restrictive limits to the treatment, that could affect policies for payers, Medicaid reimbursement, manufacturing and company performance, and have implications for getting the drug to patients at an affordable price,” Thome said.
How the FDA Could Shape Access
The FDA's approval of the generic Evita pill marked a rare expansion of the mifepristone market. The agency issued no press release or statement about the approval, a silence that 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, in part because insiders had anticipated it as a regulatory formality, O'Connor said. Under federal law, once a generic drug meets equivalency standards (meaning it works 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.
“This caught the anti-abortion movement a little by surprise, but it shouldn't have. This is the way the FDA should operate,” O'Connor said.
Behind the scenes, Trump has named 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., which could lead to stricter restrictions on telehealth and mail order, requiring in-person prescriptions for the pill or even pulling the drug from shelves.
The FDA has not detailed the scope or timeline of the review. Some experts have criticized the studies cited to justify the review as methodologically flawed; Laurie Sobel, associate director of women's health policy at KFF, told CNBC it's “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 that prohibits the mailing of “obscene” materials, including abortifacient medications. The Biden administration interpreted it restrictively to allow pills to be shipped to states where abortion is legal. But Trump's Justice Department could reinterpret the statute more broadly to block shipments of mifepristone nationwide.
Mifepristone has a 25-year safety record for terminating pregnancies in the US. Since 2021, the FDA has allowed 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 struck down the right to abortion enshrined in Roe v. Wade.
Meanwhile, pharmacies like CVS and Walgreens have not stopped prescribing mifepristone in legal states, although both maintain strict controls to limit liability.
“The more these medications are stigmatized, the more at risk pharmacies are of being stigmatized simply for providing them,” said R. Alta Charo, professor emeritus of law and bioethics at the University of Wisconsin in Madison. “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 medication.”
However, costco announced in August that it would not sell mifepristone in its in-store pharmacies due to low demand from members and other patient customers.
Dr. Franz Theard watches a patient take mifepristone, the first medication in a medication abortion, at the New Mexico Women's Reproductive Clinic in Santa Teresa on Jan. 13, 2023.
Evelyn Hockstein | Reuters
How drug makers are responding
Within the industry, drugmakers such as Danco Laboratories, GenBioPro and Evita Solutions appear to be taking steps that are likely to cushion the blow of any crackdown on mifepristone.
Danco Laboratories is seeking FDA approval to expand the approved use of mifepristone to include the management of miscarriages, The Wall Street Journal first reported. Evita and GenBioPro are also exploring new hormone therapy products.
“Companies don't always seek formal regulatory approval for a secondary or tertiary use, because to do so, you have to go through another series of clinical trials that are incredibly expensive,” Charo said. “But if they do, they will gain an advantage.
GenBioPro also remains embroiled in a lawsuit against the FDA and the state of West Virginia beginning in 2023, arguing that the state's ban on mifepristone conflicts with federal approval authority, a concept known as “federal preemption.” The case remains under appeal, but more litigation is likely if future federal directives limit telehealth access to mifepristone.
“There's been a lot of litigation around mifepristone in recent years, and there's a lot of concern on the part of drug companies with 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 two medications 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 | fake images
State-level differences in access to the abortion pill
As drug makers evaluate potential federal changes, they have to navigate a wide range of state policies.
The number of abortions in states with complete bans or early gestation limits saw sharp declines immediately after the Supreme Court's 2022 Dobbs ruling, but has seen a slight decline since Trump took office, according to the Guttmacher Institute. Nationally, the number of abortions increased in 2023 and 2024, even with bans on the surgical procedure in a dozen states.
No state has enacted a new ban on medical abortion since Trump's election. In fact, voters in seven states passed ballot measures to protect abortion rights, often enshrining them in their state constitutions. However, some states have tightened enforcement of pre-existing abortion bans.
Texas, Louisiana and Idaho have expanded penalties for mailing abortion pills, while Texas' “bounty hunter law” allows private citizens to sue anyone who helps facilitate an illegal abortion, including counseling or mailing pills.
Those measures are subject to a series of ongoing lawsuits. Still, the ban on mail-order pills has proven difficult to implement, Charo said. The USPS does not 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.
Still, the mere prospect of legal action has had a chilling effect on providers who fear prescribing mifepristone, via telehealth or by mail, to patients in every state where the drug is legal but surgical abortion is not.
“Louisiana has sued a New York doctor for performing a telehealth medication abortion on someone in Louisiana. Texas has sued a New York doctor for doing the same thing,” O'Connor said. “That, in itself, has a really serious deterrent effect on doctors feeling comfortable prescribing.”
Meanwhile, states like California and New York have strengthened “shield laws” that protect providers who treat patients from other states. Still, funding cuts, staffing shortages and growing out-of-state demand have forced some clinics to close.
“Regardless of whether abortion is legal or not, clinics are struggling to stay open,” says KFF's Sobel. “The Big Beautiful Bill has cut funding for Planned Parenthood and funding for other types of family planning… It is also restrictions on federal funding that are affecting the capacity of clinics that also regularly see Medicaid patients.”
