FDA quietly approved a generic abortion pill ahead of shutdown

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.

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.

Mifepristone is typically used in combination with another pill, misoprostol, to induce abortions. Medication abortions account for nearly two-thirds of abortions in the U.S.

The FDA wrote in a letter to Evita Solutions on Tuesday, the day before the government shutdown began, that its mifepristone tablets were “therapeutically equivalent” to the brand-name version, Mifeprex, which has been available in the U.S. since 2000.

On its website, Evita Solutions describes its mission as assisting “the medical community in recognizing the utility and freedom that medical abortion provides patients.”

“We seek to normalize abortion care, and we commit to making care accessible to all,” it adds.

The company did not immediately respond to a request for comment.

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’s safety.

In the letter, Kennedy and FDA Commissioner Marty Makary wrote that the FDA’s past decisions to roll back certain restrictions on mifepristone access had not been given “adequate consideration” at the time.

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.

“The 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,” Nixon said in a statement.

“Generic applicants are not required to submit independent evidence proving safety and effectiveness,” he added. “HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”

The FDA often issues a press release after new or significant drug approvals, but did not in this case.

The approval provoked a furious response from Marjorie Dannenfelser, the president of the anti-abortion group SBA Pro-Life America.

“Secretary 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,” she said. “The prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug.”

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.

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 “underscores what research has shown for decades: medication abortion is safe, effective, and essential health care, used by millions with proven efficacy.”

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’s use. (The first, in 2016, said that mifepristone could be used up to 10 weeks’ 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.)

In their letter last month, Kennedy and Makary cited an April report 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.

Over the last several months, many conservatives have cited the report as a reason the FDA should look more closely at mifepristone’s safety. In July, 22 Republican attorneys general sent a letter to Kennedy and Makary to that effect; the letter the two sent last month was a response to that request.

Anti-abortion groups have in the past been skeptical of Kennedy, a former Democrat who ran for president in 2023 as a proponent of abortion rights. He later said he supported restrictions after a certain point in a pregnancy. Kennedy’s stance on abortion was a source of consternation for some conservatives during his Senate confirmation hearing.