The Food and Drug Administration on Tuesday has discreetly approved a generic form of mifepristone, one of the two drugs used in most American abortions.
This makes the drug, the company Evita Solutions, the second generic version to arrive on the market. The first, from the pharmaceutical company Genbiopro, was approved in 2019.
Miffepristone is generally used in combination with another pill, misoprostol, to induce abortions. Drug abortions represent almost two thirds of abortions in the United States
The FDA wrote in a letter to Evita Solutions on Tuesday, the day before the start of the government’s closure, that its Mifepristone tablets were “therapeutically equivalent” to the brand version, Mifeprex, which has been available in the United States since 2000.
On its website, Evita Solutions describes its mission as helping “the medical community to recognize the usefulness and freedom that medical abortion provides to patients”.
“We are looking to normalize abortion care, and we are committed to making care accessible to everyone,” he adds.
The company did not immediately respond to a request for comments.
FDA approval comes less than two weeks after the Secretary of Health and Social Services, Robert F. Kennedy Jr.
In the letter, Kennedy and the FDA commissioner, Marty Makary, wrote that the past decisions of the FDA to make some restrictions back on access to mifepristone had not been “considerable” at the time.
Andrew Nixon, spokesperson for the Department of Health and Social Services, said that the FDA does not approve of drug products and orders prescribers to follow any labeling.
“The FDA has a very limited discretion to decide to provide a generic drug. According to law, the secretary of health and social services must approve a request if it demonstrates that the generic drug is identical to the brand medication,” Nixon said in a statement.
“Generic candidates are not required to submit independent evidence proving security and efficiency,” he added. “HHS is studying the reported side effects of mifepristone to ensure that the FDA risk attenuation program for medication is sufficient to protect women from unconcluded risks.”
The FDA often issues a press release after new or important drug approvals, but has not done in this case.
The approval caused a furious response from Marjorie Dannenfelser, president of the SBA Pro-Life America anti-abortion group.
“Secretary Kennedy and the FDA commissioner Makary assured the Congress and the American people, they would carry out an in-depth examination given the credible proof of the damage inflicted by these drugs,” she said. “The rapid completion of the examination is made more urgent given this approval to flood the market of a cheap abortion drug.”
Research by peers has long shown that serious adverse reactions of 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 first blocks the progesterone hormone, which supports pregnancy, and the second induces contractions.
Brittany Fonteno, CEO of the National Abortion Federation, the professional association of abortions suppliers, said in a statement that the approval of a second generic drug for mifepristone “underlines what research has shown for decades: the drug abortion is safe, effective and essential of health care, used by millions of people with proven effectiveness.
Anti-abortion activists have called for years the FDA to revoke the approval of the first generic medication for mifepristone, as well as two changes of specific rules for the use of the drug. (The first, in 2016, said that mifepristone could be used up to 10 weeks of gestation instead of seven, and the second, in 2021, eliminated a requirement according to which the mifepristone was dispensed in person, which allows it to be prescribed via the TV and sent by La Poste nationale.)
In their letter last month, Kennedy and Makary cited an April report by a conservative reflection group, the Center for Ethics and Public Policy, which claimed to find a higher rate of serious mifepristone complications that the FDA declared it. But this report was not evaluated or published in a medical journal, and reproductive health researchers said it was equivalent to junk food sciences.
In recent months, many conservatives have cited the report as a reason why the FDA should take a closer look at the security of Mifepristone. In July, the 22 Public Prosecutor General sent a letter to Kennedy and Makary for this purpose; The letter that the two sent last month was an answer to this request.
The anti-abortion groups have been skeptical in the past with Kennedy, a former democrat who presented himself to the presidency in 2023 as a supporter of abortion rights. He later declared that he had supported the restrictions after a certain point in a pregnancy. Kennedy’s position on abortion was a source of dismay for certain preservatives during his confirmation audience of the Senate.
