The Food and Drug Administration has approved a generic version of the abortion pill mifepristone, expanding its supply at a time when the Trump administration is under pressure from abortion opponents to sharply restrict access to abortion pills.
The approval, issued on Tuesday without a public announcement, means that three American companies can now produce mifepristone for abortion. The F.D.A. approved the original pill 25 years ago and in 2019 approved the first generic version.
The decision comes as anti-abortion activists have been urging the F.D.A. and the Department of Health and Human Services to curtail access to abortion pills. They have been prescribed in increasing numbers in the years since the Supreme Court overturned the national right to abortion in 2022.
Currently, nearly two-thirds of abortions in the country are carried out with medication. Access to abortion pills, especially through telemedicine, is a major reason that the number of abortions in the United States has not decreased since the Supreme Court 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.
A spokesman for H.H.S., Andrew Nixon, said in a statement that “the F.D.A. has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.”
Although many of President Trump’s supporters, and officials in his government, are strongly anti-abortion, his second administration has said and done much less than abortion opponents want. It has cut funds for family planning and rolled back some policies, including on emergency access to abortion, but has not taken major steps to curtail access, such as banning the delivery of abortion pills through the mail.
The F.D.A.’s mission is intended to be apolitical and rooted in scientific evidence. Reviews of drug applications are conducted by the agency’s scientists and technical experts and often involve detailed examinations and back-and-forth with the companies applying for approval.
“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.”
In response to pressure from anti-abortion groups and Republican politicians, Health Secretary Robert F. Kennedy Jr. and the F.D.A. commissioner, Dr. Martin Makary, have said that the agency will study the safety of mifepristone.
In a letter last month responding to Republican state attorneys general, Mr. Kennedy and Dr. Makary wrote: “H.H.S. — through 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 added, “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 experts and supporters of abortion rights have filed letters and briefs pointing out that scores of studies have documented that mifepristone is safe and that serious complications are rare.
Mr. Nixon, the H.H.S. spokesman, said that companies seeking generic approval do not have to undergo the same process as applications seeking first-time approval of a drug. “Generic applicants are not required to submit independent evidence proving safety and effectiveness.”
The company that received the approval, Evita Solutions, issued a statement on Thursday saying that “availability of our product will expand patients’ options for medication abortion with an affordable product backed by decades of safe use.” The company said it expected the product to become available in January.
Medication abortion is typically a two-drug regimen in which mifepristone is taken to stop the development of a pregnancy and is followed 24 to 48 hours later by another drug, misoprostol, which causes contractions similar to a miscarriage. The regimen is used in the United States up through 12 weeks of pregnancy.
The F.D.A. said the same standards and regulations would apply to the new generic version of mifepristone as are followed by the other two manufacturers.
Supporters of abortion rights welcomed the F.D.A.’s 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.”
Anti-abortion advocates vowed to continue to press 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.”
Pam Belluck is a health and science reporter for The Times, covering a range of subjects, including reproductive health, long Covid, brain science, neurological disorders, mental health and genetics.
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