The Food and Drug Administration (FDA) has officially approved a new generic version of mifepristone, a key medication used in abortions. This move significantly increases the supply of the pill at a time when the Trump administration faces immense pressure from abortion opponents seeking to heavily restrict access to such medications.
This approval, quietly issued, means that a total of three American companies are now authorized to produce mifepristone for abortion care. The FDA originally approved the brand-name pill 25 years ago, with the first generic version receiving approval in 2019.
This decision arrives amidst fervent calls from anti-abortion activists urging the FDA and the Department of Health and Human Services (HHS) to limit the availability of abortion pills. Notably, these medications have seen a surge in prescriptions since the Supreme Court’s 2022 decision to overturn the national right to abortion.
Today, medication abortion accounts for nearly two-thirds of all abortions performed nationwide. The accessibility of these pills, particularly through telemedicine, has been a critical factor in preventing a more significant decline in abortion rates following the Supreme Court’s ruling.
Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, condemned the approval in a statement, calling it a “reckless decision by the F.D.A. to expand the availability of abortion drugs” that is “unconscionable.”
However, an HHS spokesman, Andrew Nixon, clarified 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.”
Despite strong anti-abortion sentiments among many of President Trump’s supporters and within his administration, his second term has notably refrained from taking the drastic measures some opponents desired. While some family planning funds have been cut and certain policies, like emergency abortion access, rolled back, major steps to curtail access, such as a federal ban on mailing abortion pills, have not been implemented.
The FDA’s core mission remains apolitical, grounded in scientific evidence. Drug application reviews are conducted by the agency’s scientists and technical experts, involving thorough examinations and ongoing communication with pharmaceutical companies seeking approval.
“This is exactly how our system is supposed to work, and it has worked this way for decades,” stated Mini Timmaraju, president and chief executive of Reproductive Freedom for All. She added, “Career scientists and civil servants at the F.D.A. did their jobs — evaluating the evidence and approving a safe, effective medication.”
Under pressure from anti-abortion groups and Republican politicians, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary have indicated that the agency will conduct its own safety study of mifepristone.
In a letter to Republican state attorneys general last month, Kennedy and Makary confirmed that “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 emphasized 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.”
Conversely, medical experts and supporters of abortion rights have submitted extensive documentation, including numerous studies, affirming that mifepristone is safe and that serious complications are exceptionally rare.
Mr. Nixon from HHS reiterated that generic drug applications are subject to a different process than initial drug approvals. “Generic applicants are not required to submit independent evidence proving safety and effectiveness,” he noted.
Evita Solutions, the company behind the latest approval, issued a statement Thursday, highlighting that “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 being available by January.
Medication abortion typically involves a two-drug protocol: mifepristone is taken first to halt pregnancy development, followed 24 to 48 hours later by misoprostol, which induces contractions akin to a miscarriage. This regimen is approved for use in the United States for pregnancies up to 12 weeks.
The FDA confirmed that the same stringent standards and regulations applied to existing mifepristone manufacturers will also govern the new generic version.
Supporters of abortion rights broadly applauded the FDA’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, director of the Expanding Medication Abortion Access Project. She asserted, “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.”
Meanwhile, anti-abortion advocates have pledged to redouble their efforts to influence the administration.
“President Trump believes states have the right to pass and enforce pro-life protections,” Ms. Dannenfelser stated, lamenting that “Yet every day this right is being trampled upon by the abortion industry.”