F.D.A. Approves a New Generic Abortion Pill
The decision enraged opponents of abortion, who have been pressuring the administration to restrict access to abortion medication.
By Pam Belluck
Oct. 2, 2025, 4:46 p.m. ET
The Food and Drug Administration this week approved a generic version of the abortion pill mifepristone, expanding the supply of the medication 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, means that three American companies can now produce mifepristone for abortion. The F.D.A. approved the original pill 25 years ago and gave approval in 2019 for another company to produce a generic version.
The decision comes at a time when anti-abortion advocates have been urging the F.D.A. and the department of Health and Human Services to take action to curtail access, especially by rolling back steps the agency took in recent years to allow the pills to be prescribed without an in-person doctor visit and sent to patients by mail.
“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 Thursday.
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. 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.
On Thursday, 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.”
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