This week, the Food and Drug Administration (FDA) officially approved a generic version of the abortion pill mifepristone, a move set to increase the supply of this medication. This approval comes at a time when the Trump administration is under significant pressure from abortion opponents who seek to severely restrict access to abortion pills.
Issued on Tuesday, this latest approval means that a total of three American companies are now authorized to produce mifepristone for abortion. The FDA originally approved the brand-name pill 25 years ago and later gave approval in 2019 for a different company to launch its generic version.
This critical decision coincides with heightened efforts by anti-abortion advocates. These groups have been actively urging both the FDA and the Department of Health and Human Services (HHS) to take action that would curtail access, particularly by reversing recent agency steps that permit pills to be prescribed without an in-person doctor’s visit and mailed directly to patients.
“This reckless decision by the F.D.A. to expand the availability of abortion drugs is unconscionable,” declared Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, in a statement released Thursday following the new pill’s approval.
Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary have both stated that the agency will conduct a study into the safety of mifepristone. However, medical experts and supporters of abortion rights have already submitted numerous letters and briefs, emphasizing that a multitude of studies consistently demonstrate mifepristone’s safety and the rarity of serious complications.
On Thursday, Andrew Nixon, a spokesman for HHS, issued a statement clarifying 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.”