Access to the abortion pill mifepristone remains stable under Trump, with an FDA review pending

Mifepristone and misoprostol pills are pictured on Wednesday, October 3, 2018, in Skokie, Illinois.

Erin Holey | Chicago Tribune | Tribune News Service | Getty Images

Just over a year since Donald Trump was re-elected president, 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 emerging.

Between a Food and Drug Administration safety review that could upend distribution, legal battles over whether the pill should be allowed to 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 sector of the health care industry.

“When it comes to medication abortion, there have been no major policy changes in this administration,” said Katie O’Connor, senior director of federal abortion policy at the National Women’s Law Center. “But we have also seen some signals from the government that they are going to do something.”

Currently, the FDA allows the pill mifepristone to be prescribed via telemedicine and delivered by mail. Certified pharmacies still provide dispensing in about half of U.S. states, depending on state law.

Along with misoprostol, mifepristone forms the standard two-drug therapy used in the United States for more than two decades and accounts for about two-thirds of abortions annually, according to the Guttmacher Institute.

Even though Trump and many key anti-abortion advisers have been in power for more than a year, production of mifepristone has not declined. And in September, the FDA quietly approved a generic version from Evita Solutions, the first new U.S. manufacturer since 2019, to terminate pregnancies up to 10 weeks.

But analysts like Joe Thome at TD Cowenwho oversees the FDA say the risk to the market and access to abortion is greater than it seems.

Even small changes in federal regulations could impact 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 warnings or more restrictive treatment limits, it could impact payer policies, Medicaid reimbursement, companies’ production and performance, and impact the ability of the drug to actually get to patients at an affordable price,” 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 did not issue a press release or statement on the approval, a silence that Thome and many abortion rights advocates interpreted as an attempt to prevent a resurgence of one of the country’s most polarizing debates.

Pharma stocks made little progress on approval, in part because insiders assumed it would be a regulatory formality, O’Connor said. Once a generic meets equivalence standards — meaning it works in the body in the same way as the brand-name version — the FDA has little discretion under federal law to block it, according to the Department of Health and Human Services.

“It took the anti-abortion movement a little by surprise, but that shouldn’t have happened. That’s what the FDA is supposed to do,” O’Connor said.

Behind the scenes, Trump has appointed FDA officials sympathetic to abortion opponents since returning to office. In May, at the behest of HHS Secretary Robert F. Kennedy Jr., the agency launched a controversial safety review of mifepristone that could lead to tighter restrictions on telemedicine and mail-order sales, require in-person doctor’s prescriptions for the pill or even pull the drug from shelves.

The FDA did not detail the scope or timing of the review. Some experts criticized the studies used to justify the review as methodologically flawed; Laurie Sobel, deputy director of women’s health policy at KFF, told CNBC that it’s “garbage science.”

Trump has different levers than the FDA if he wants to restrict access, experts say.

Chief among them is the revival of the 19th-century Comstock Act — a dormant law that bans the shipment of “obscene” materials, including abortion drugs. The Biden administration interpreted it narrowly, allowing pill deliveries in states where abortion is legal. However, the Trump Justice Department could interpret the law more broadly to block nationwide shipments of mifepristone.

Mifepristone has a 25-year safety record in terminating pregnancies in the United States. Since 2021, the FDA has approved telemedicine and mail-order prescriptions, making abortions cheaper and more accessible, especially for women far from clinics or in states that had restricted the procedure following Dobbs v. Jackson Women’s Health Organization, the Supreme Court decision that struck down the abortion rights enshrined in Roe v. Wade.

Meanwhile, pharmacies like it CVS And Walgreens have not stopped prescribing mifepristone in legal states, despite both maintaining strict controls to limit liability.

“The more these drugs are stigmatized, the greater the risk that the pharmacies themselves will be stigmatized simply for offering the drugs,” said R. Alta Charo, professor emeritus of law and bioethics at the University of Wisconsin at Madison. “At some point, these pharmacies may say we don’t want to get involved and may just decide to no longer stock the drug.”

However, Costco announced in August that it would not sell mifepristone in its store pharmacies due to low demand from members and other patient customers.

Dr. Franz Theard watches a patient take mifepristone, the first drug in a medical abortion, at the Women’s Reproductive Clinic of New Mexico in Santa Teresa on Jan. 13, 2023.

Evelyn Hockstein | Reuters

How drug manufacturers react

Within the industry, drugmakers such as Danco Laboratories, GenBioPro and Evita Solutions appear to be taking steps that would likely cushion the impact of a crackdown on mifepristone.

Danco Laboratories is seeking FDA approval to expand the approved use of mifepristone to treat miscarriages, the Wall Street Journal first reported. Evita and GenBioPro are also researching new products for hormone therapy.

“Companies don’t always seek formal regulatory approval for secondary or tertiary use because that requires going through another series of clinical trials, which are incredibly expensive,” Charo said. “But if they do, then they have an advantage.

GenBioPro also remains embroiled in a lawsuit against the FDA and the state of West Virginia as of 2023, arguing that the state’s ban on mifepristone conflicts with federal regulatory authority, a concept known as “federal preemption.” The case remains under appeal, but more litigation would likely follow if future federal guidelines restrict access to mifepristone for telemedicine.

“There has been a lot of litigation surrounding mifepristone in recent years, and pharmaceutical companies are very concerned about a court telling the FDA how to proceed,” Caroline Sacerdote, a trial attorney 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 on display 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 disparities in access to abortion pills

As drugmakers take stock of possible federal changes, they must contend with a wide range of state policies.

According to the Guttmacher Institute, the number of abortions in states with total bans or early pregnancy restrictions fell sharply immediately after the Supreme Court’s 2022 Dobbs ruling, but has declined slightly since Trump took office. Nationwide, the number of abortions rose in 2023 and 2024 despite bans on the surgical procedure in a dozen states.

Since Trump’s election, no state has passed a new ban on medication abortions. In fact, voters in seven states approved ballot measures protecting abortion rights, often by enshrining them in their state constitutions. However, enforcement of existing abortion bans has been tightened in some states.

Texas, Louisiana and Idaho have expanded penalties for mailing abortion pills, while Texas’s “bounty hunter law” allows private citizens to sue anyone who facilitates an illegal abortion – even by recommending or mailing pills.

These measures are the subject of a number of ongoing legal disputes. Still, bans on mail-order pills have proven difficult to enforce, Charo said. The U.S. Postal Service 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 very possibility of legal action has had a chilling effect on providers fearful of prescribing mifepristone via telemedicine or by mail to patients across state lines where the drug is legal but surgical abortions are not.

“Louisiana sued a doctor in New York for providing telemedicine abortions to someone in Louisiana. Texas sued a doctor in New York for doing the same thing,” O’Connor said. “That alone has a real chilling effect on doctors who are just as comfortable prescribing.”

Meanwhile, states like California and New York have tightened “shield laws” that protect providers who treat patients out of state. However, funding cuts, staff shortages and increasing demand from abroad have forced some clinics to close.

“Regardless of whether abortion is legal, clinics are struggling to stay open,” KFF’s Sobel said. “The Big Beautiful Bill has cut funding for Planned Parenthood and funding for other family planning… It is also federal funding limitations that impact the ability of clinics that regularly treat Medicaid patients.”