The Food and Drug Administration has given its nod to a generic version of the abortion pill mifepristone. This move significantly boosts the availability of the medication, arriving at a critical juncture as the Trump administration faces mounting pressure from abortion opponents to severely limit access to such pills.
The approval, quietly granted on Tuesday, expands the number of U.S. companies authorized to manufacture mifepristone for abortion to three. The FDA first approved the original medication a quarter-century ago, with the initial generic version following in 2019.
This decision emerges amidst intense lobbying from anti-abortion activists, who have been pressuring both the FDA and the Department of Health and Human Services to curb the availability of abortion pills. Prescriptions for these medications have surged since the 2022 Supreme Court ruling that eliminated the national right to abortion.
Medication abortion currently accounts for almost two-thirds of all abortions performed nationwide. The continued availability of abortion pills, particularly through telehealth services, is a key factor in why the overall number of abortions in the U.S. has not declined following the Supreme Court’s landmark decision.
“This reckless decision by the F.D.A. to expand the availability of abortion drugs is unconscionable,” Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said of the approval of the new pill in a statement.
In response, Andrew Nixon, a spokesperson for the Department of Health and Human Services, clarified that the FDA operates with “very limited discretion” when evaluating generic drug applications. He stated that federal law mandates the Secretary of Health and Human Services to approve an application if it proves the generic drug is chemically identical to its brand-name counterpart.
Despite strong anti-abortion sentiments among many of President Trump’s supporters and within his administration, his second term has not enacted the sweeping restrictions that abortion opponents desire. While funding for family planning has been reduced and certain policies, like emergency abortion access, have been scaled back, no significant measures, such as a ban on mailing abortion pills, have been implemented to broadly restrict access.
The F.D.A.’s core mission is designed to be non-political, founded on rigorous scientific evidence. Its drug application review process involves thorough scrutiny by agency scientists and technical experts, often including extensive communication with applicant companies.
“This is exactly how our system is supposed to work, and it has worked this way for decades,” Mini Timmaraju, the president and chief executive of Reproductive Freedom for All, said in a statement. “Career scientists and civil servants at the F.D.A. did their jobs — evaluating the evidence and approving a safe, effective medication.”
Facing continuous pressure from anti-abortion organizations and Republican lawmakers, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary announced that the agency plans to conduct a safety study of mifepristone.
In a recent letter addressed to Republican state attorneys general, Mr. Kennedy and Dr. Makary stated that the H.H.S., via the F.D.A., “is conducting its own review of the evidence, including real-world outcomes and evidence relating to the safety and efficacy of the drug.”
They further noted that, “The concerns you have raised in your letter merit close examination. This administration will ensure that women’s health is properly protected by thoroughly examining the circumstances under which mifepristone can be safely dispensed.”
Medical professionals and advocates for abortion rights have submitted numerous letters and briefs, consistently highlighting that extensive research confirms mifepristone’s safety and the rarity of serious complications.
Mr. Nixon, the H.H.S. spokesman, reiterated that companies applying for generic drug approval are not subject to the same stringent process as those seeking initial drug approval. He clarified, “Generic applicants are not required to submit independent evidence proving safety and effectiveness.”
Evita Solutions, the company granted the recent approval, announced on Thursday that the “availability of our product will expand patients’ options for medication abortion with an affordable product backed by decades of safe use.” They anticipate the product will be on the market by January.
Medication abortion typically involves a two-step process: first, mifepristone to halt pregnancy development, followed 24 to 48 hours later by misoprostol to induce contractions similar to a miscarriage. This regimen is approved for use in the U.S. for pregnancies up to 12 weeks.
The F.D.A. confirmed that the new generic version of mifepristone will be subject to the identical standards and regulations already applied to the other two authorized manufacturers.
Advocates for abortion rights largely lauded the F.D.A.’s recent decision.
“The F.D.A.’s approval of a generic mifepristone for early medication abortion care is welcome news for patients, providers, and the public,” said Kirsten Moore, the director of the Expanding Medication Abortion Access Project. “Despite ongoing attempts by anti-abortion activists to spread fear and misinformation, the F.D.A. continues to do its job of following the science, ensuring safety, and expanding access to essential health care.”
Conversely, anti-abortion proponents pledged to maintain pressure on the administration.
“President Trump believes states have the right to pass and enforce pro-life protections,” Ms. Dannenfelser said. “Yet every day this right is being trampled upon by the abortion industry.”
Research for this report was contributed by Susan C. Beachy.