The Food and Drug Administration on Tuesday quietly approved a generic form of mifepristone, one of the two medications used in most U.S. abortions.<\/p>\n
That makes the drug, from the company Evita Solutions, the second generic version to hit the market. The first, from pharmaceutical company GenBioPro, was approved in 2019.<\/p>\n
Mifepristone is typically used in combination with another pill, misoprostol, to induce abortions. Medication abortions account for nearly two-thirds of abortions<\/a> in the U.S. <\/p>\n The FDA wrote in a letter to Evita Solutions<\/a> on Tuesday, the day before the government shutdown began, that its mifepristone tablets were \u201ctherapeutically equivalent\u201d to the brand-name version, Mifeprex, which has been available in the U.S. since 2000. <\/p>\n On its website<\/a>, Evita Solutions describes its mission as normalizing abortion care and assisting \u201cthe medical community in recognizing the utility and freedom that medical abortion provides patients.\u201d<\/p>\n \u201cAvailability of our product will expand patients\u2019 options for medication abortion with an affordable product backed by decades of safe use. The new product is expected to be available in January 2026,\u201d the company said in a statement.<\/p>\n The FDA approval comes less than two weeks after Health and Human Services Secretary Robert F. Kennedy Jr. told Republican state attorneys general in a letter that the FDA would review mifepristone\u2019s safety. <\/p>\n In the letter, Kennedy and FDA Commissioner Marty Makary wrote that the FDA\u2019s past decisions to roll back certain restrictions on mifepristone access had not been given \u201cadequate consideration\u201d at the time.<\/p>\n Andrew Nixon, a spokesperson for the Health and Human Services Department, said the FDA does not endorse drug products and directs prescribers to follow all labeling. <\/p>\n \u201cThe FDA 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,\u201d Nixon said in a statement. <\/p>\n \u201cGeneric applicants are not required to submit independent evidence proving safety and effectiveness,\u201d he added. \u201cHHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA\u2019s risk mitigation program for the drug is sufficient to protect women from unstated risks.\u201d<\/p>\n The FDA often issues a press release after new or significant drug approvals, but did not in this case.<\/p>\n The approval provoked a furious response from Marjorie Dannenfelser, the president of the anti-abortion group SBA Pro-Life America.<\/p>\n \u201cSecretary Kennedy and FDA Commissioner Makary assured Congress and the American people they would conduct a thorough review given credible evidence of the harm inflicted by these drugs,\u201d she said. \u201cThe prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug.\u201d<\/p>\n Sen. Bill Cassidy, R-La., the chair of the Health, Education, Labor and Pensions Committee, which oversees the FDA chimed in on X:<\/a> \u201cI fully support President Trump\u2019s Pro-Life, Pro-Family agenda, but the FDA approving one more tool to kill babies is a betrayal. This is not what Commissioner Makary and Secretary Kennedy indicated they would do in their confirmation hearings.\u201d<\/p>\n Peer-reviewed research has long shown that serious adverse reactions from abortion pills are rare. In combination, mifepristone and misoprostol can be used up to 70 days after the start of the last menstrual period. The former blocks the hormone progesterone, which supports pregnancy, and the latter induces contractions. <\/p>\n Brittany Fonteno, CEO of the National Abortion Federation, the professional association of abortion providers, said in a statement that the approval of a second generic drug for mifepristone \u201cunderscores what research has shown for decades: medication abortion is safe, effective, and essential health care, used by millions with proven efficacy.\u201d <\/p>\n Anti-abortion activists have for years called on the FDA to revoke the approval of the first generic drug for mifepristone, as well as two particular rule changes for the drug\u2019s use. (The first, in 2016, said that mifepristone could be used up to 10 weeks\u2019 gestation instead of seven, and the second, in 2021, eliminated a requirement that mifepristone be dispensed in person, allowing it to be prescribed via telehealth and mailed nationwide.)<\/p>\n In their letter last month, Kennedy and Makary cited an April report<\/a> from a conservative think tank, the Ethics and Public Policy Center, which claimed to find a higher rate of serious complications from mifepristone than reported by the FDA. But that report was not peer-reviewed or published in a medical journal, and reproductive health researchers have said it amounts to junk science<\/a>.<\/p>\n