Federal rules for the abortion pill mifepristone have not changed a year after President Donald Trump was elected again. However, a recent FDA safety review has created new uncertainties about the drug’s future.
Lawsuits and state laws are changing how easily people can get abortion pills. The $6.9 billion abortion drug industry in the U.S. depends on telehealth and mail delivery to reach patients.
Drug companies like Danco Laboratories and GenBioPro are now also moving into markets for miscarriage care and hormonal therapies.
More than a year after Donald Trump’s election, the abortion pill industry still operates under the federal rules it inherited from former President Joe Biden. But new threats are rising.
The FDA started a safety review that might change how the drug is distributed. Legal fights question whether the pill should remain on the market. Anti-abortion activists and Trump’s administration add more pressure on drugmakers.
“When it comes to medication abortion, there haven’t been major policy changes yet,” said Katie O’Connor, senior director of abortion policy for the National Women’s Law Center. “But there are signs the administration might act.”
The FDA still allows mifepristone to be prescribed by telehealth and sent by mail. Around half the U.S. states have certified pharmacies that dispense it, depending on local laws.
Mifepristone, taken with misoprostol, is the standard two-drug regimen used in the U.S. for over 20 years. It accounts for about two-thirds of abortions each year, according to the Guttmacher Institute.
Despite Trump’s reelection and the influence of anti-abortion advisors, mifepristone manufacturing has not decreased. In September, the FDA quietly approved a generic version from Evita Solutions, the first new U.S. maker since 2019.
Experts warn even small federal rule changes could disrupt insurance, telemedicine, and pharmacy compliance, affecting how mifepristone makers like GenBioPro, Evita Solutions, and Danco Laboratories operate.
“If the FDA adds warning labels or tighter limits, it affects payers’ policies, Medicaid payments, and the drug’s availability and price,” said Joe Thome from TD Cowen.
The FDA’s quiet approval of Evita’s generic pill surprised some but was expected legally, according to O’Connor. Federal law requires approval if a generic drug proves equivalent to the brand.
Trump has appointed FDA officials who may side with anti-abortion groups. In May, the FDA began a safety review of mifepristone at the request of HHS Secretary Robert F. Kennedy Jr.. This review could lead to stricter telehealth rules, require in-person prescriptions, or remove the drug from shelves.
Critics, including experts like Laurie Sobel at KFF, call the review’s scientific basis “junk science.”
Beyond the FDA, the Trump administration could try to enforce the 19th-century Comstock Act. This law bans mailing “obscene” materials, including abortion drugs. The Biden administration narrowly allowed mail shipments to states where abortion is legal, but the Trump Justice Department could block all mail shipments of mifepristone nationwide.
Mifepristone has 25 years of safety data supporting its use. Since 2021, FDA rules allow telehealth and mail prescriptions, making abortion care more affordable and accessible, especially in states restricting surgical abortion after the Supreme Court overturned Roe v. Wade.
Pharmacies like CVS and Walgreens continue to prescribe mifepristone in legal states but with strict controls to limit risks. However, some pharmacies risk reputational harm by providing the drug.
Costco announced in August it would not sell mifepristone in its U.S. store pharmacies, citing low demand.
Drugmakers are preparing for cracks in access. Danco Laboratories is seeking FDA approval to expand mifepristone use to manage miscarriages. Evita and GenBioPro are exploring hormonal therapy products.
“These companies may not always seek formal approval for new uses because trials are costly, but approval gives them benefits,” said professor emerita R. Alta Charo.
GenBioPro is also involved in a lawsuit challenging West Virginia’s ban on mifepristone, arguing federal approval preempts state laws. More challenges are expected if federal access rules tighten.
Litigation over mifepristone creates uncertainty for pharmaceutical companies and regulators.
State laws vary greatly. Since Trump took office, no new medication abortion bans have been passed, and some states have enshrined abortion rights in their constitutions.
But states like Texas, Louisiana, and Idaho have increased penalties for mailing abortion pills. Texas’s “bounty-hunter law” allows private lawsuits against anyone aiding illegal abortions, including mailing pills.
These laws face ongoing lawsuits and have so far been hard to enforce. The U.S. Postal Service does not assist states in blocking abortion pill shipments.
The threat of prosecution chills doctors from prescribing mifepristone across state lines. “Louisiana indicted a New York doctor for prescribing telehealth abortion pills to someone in Louisiana. Texas sued a similar doctor,” said O’Connor.
Some states like California and New York have “shield laws” protecting providers who treat out-of-state patients. Still, clinics struggle due to funding cuts, staff shortages, and rising out-of-state demand.
“Clinics face challenges staying open regardless of abortion legality,” said KFF’s Sobel. “Funding and federal restrictions impact family planning services and Medicaid patients as well.”
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