Access to the abortion pill mifepristone is flat under Trump, and an FDA review looms

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 it inherited from former President Joe Biden — but new threats to the drug are on the rise.

Between an FDA safety review that could upend distribution, legal battles over whether birth control pills can stay on the market, and anti-abortion rhetoric from activists and the Trump administration, drug companies appear to be bracing for a storm that could reshape a lucrative corner of the health care industry.

“When it comes to medical abortion, there haven’t been any major policy changes yet in this administration,” said Katie O’Connor, director of federal abortion policy at the National Women’s Law Center. “But we also saw some signs from the administration that they would do something.”

Currently, the FDA allows the birth control pill, mifepristone, to be prescribed via telehealth and delivered by mail. Authorized pharmacies still distribute it in about half of US states, depending on state law.

Mifepristone, when taken with misoprostol, constitutes 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 miscarriages annually, according to the Guttmacher Institute.

Although Trump and several key anti-abortion advisers have been in power for more than a year, mifepristone manufacturing has not declined. In September, the Food and Drug Administration quietly approved a generic version of Evita Solutions, the first new U.S. product since 2019, to end pregnancies within 10 weeks.

However, analysts like Joe Tom V TD Queenwhich covers the U.S. Food and Drug Administration, says there’s more risk to the market and access to abortion than it might seem.

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

“If the FDA adds warning labels or more restrictive restrictions on the treatment, that could trickle down to payer policies, Medicaid reimbursement, company production and performance, and have implications for actually getting the drug to patients at a reasonable price,” Tom said.

The US Food and Drug Administration’s (FDA) approval of the generic Evita pill was a rare expansion in the mifepristone market. The agency did not issue a press release or statement about the approval, a silence that Tom and many abortion rights advocates interpreted as an attempt to avoid reigniting one of the country’s most polarizing debates.

Drug stocks barely moved after approval, O’Connor said, partly because insiders expected it as a regulatory formality. Under federal law, once a generic drug meets the criteria for equivalence — 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.

“It caught the anti-abortion movement a little bit by surprise, but it wasn’t supposed to happen. This is the way the FDA is supposed to work,” 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 review of the safety of mifepristone at the request of Health and Human Services Secretary Robert Kennedy Jr., which could lead to tighter restrictions on telehealth and mail-orders, require in-person doctor prescriptions for the pill or even pull the drug from shelves.

The FDA has not detailed the scope or timeline of the review. Some experts criticized the studies cited in the review as methodologically flawed; It’s “junk science,” Lori Sobel, associate director of women’s health policy at KFF, told CNBC.

Experts said Trump has other tools beyond the FDA if he wants to limit access.

Chief among them is the revival of the 19th-century Comstock Act, a dormant law that prohibited the mailing of “obscene” materials, including abortion medications. The Biden administration interpreted it narrowly to allow birth control pills to be shipped to states where abortion is legal. But Trump’s Justice Department could reinterpret the law more broadly to block nationwide shipments of mifepristone.

Mifepristone has a 25-year safety record for terminating pregnancies in the United States. Since 2021, the Food and Drug Administration has allowed telehealth and prescriptions to be delivered by mail, making abortions cheaper and more accessible, especially for women far from clinics or in states that restricted the procedure after Dobbs v. Women’s Health, the Supreme Court decision that struck down abortion rights established in Roe v. Wade.

Meanwhile, pharmacies such as CVS and Walgreens It has not stopped prescribing mifepristone in legal states, although both maintain strict controls to limit liability.

R. said. “The more these drugs are stigmatized, the more the pharmacies themselves risk being stigmatized simply by providing the drugs,” said 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 this, and they may decide not to stock the drug.”

but, Costco It announced in August that it would no longer sell mifepristone in its store pharmacies due to decreased demand from members and other sick customers.

Within the industry, pharmaceutical companies, such as Danco Laboratories, GenBioPro, and Evita Solutions, appear to be taking steps that will likely soften 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 secondary or tertiary use, because to do that, you have to undergo another set of incredibly expensive clinical trials,” Charo said. “But if they do, they will have an advantage.

GenBioPro also remains involved 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 approval authority, a concept known as “federal preemption.” The case is still under appeal but more litigation is likely to follow if future federal guidance restricts telehealth access to mifepristone.

“There’s been a lot of litigation around mifepristone in the last few years, and there’s a lot of unease by drug companies about the court telling the FDA how to act,” Carolyn Sacerdote, a litigator at the Center for Reproductive Rights, told CNBC. “That’s not protocol.”

As drugmakers evaluate potential federal changes, they must navigate a wide range of state policies.

The number of abortions in states that imposed outright bans or early pregnancy limits saw a sharp decline immediately after the Supreme Court’s Dobbs ruling in 2022, but has seen a slight decline since Trump took office, according to the Guttmacher Institute. Nationally, the number of abortions rose in 2023 and 2024 even as the surgical procedure was banned in dozens of states.

No state has enacted new medical abortion bans 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 pre-existing abortion bans has been tightened.

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 — even by providing counseling or mailing pills.

These measures are the subject of a number of ongoing lawsuits. However, a ban on mail-order pills has proven difficult to implement, Charo said. The USPS does not proactively help states enforce embargoes 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 help.

However, the mere possibility of legal action has had a chilling effect on providers who are afraid to prescribe mifepristone, via telehealth or by mail, to patients across state lines where the drug is legal but surgical abortion is not.

“Louisiana charged a New York doctor with providing a remote medical abortion to someone in Louisiana. Texas sued a New York doctor for doing the same thing,” O’Connor said. “That in itself has a very chilling effect on doctors who are comfortable prescribing the drug.”

Meanwhile, states like California and New York have strengthened “shield laws” that protect providers who treat out-of-state patients. However, funding cuts, staffing shortages and high out-of-state demand 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 cuts funding for Planned Parenthood and funding for other family planning methods…And the limitations on federal funding are impacting the capacity of clinics that regularly see Medicaid patients as well.”