FDA approves a second generic abortion pill despite opposition
Secretary of Health and Human Services Robert F. Kennedy Jr. speaks about autism with President Donald Trump in the Roosevelt Room of the White House in Washington, D.C., on Sept. 22. Photo by Francis Chung/UPI | License Photo
The Trump administration this week approved a second generic abortion pill despite opposition from Republicans and anti-abortionists.
The Food and Drug Administration approved the mifepristone drug by Evita Solutions on Tuesday, though there was no official announcement.
This is the second generic abortion pill to be approved by the FDA, with Mifeprex, the original brand-name mifepristone pill, receiving approval back in 2000.
Mifepristone has gained more attention in the United States since June 2022, when the conservative-leaning Supreme Court removed federal protections for access to abortion with the overturning of the landmark 1973 Roe vs. Wade ruling.
While President Donald Trump said during his campaign that he would ensure the FDA would not block access to abortion pills, he has been under pressure to restrict access to it by Republicans and anti-abortion activists.
Since returning to office in January, his administration has taken steps critics worry will impose greater restrictions on medication abortions nationwide.
Robert F. Kennedy Jr., secretary of the Department of Health and Human Services, said Thursday on X that the FDA only approved the drug this week “because federal law requires approval when an application proves the generic is identical to the brand-name drug.”
With the statement he published a letter that he and FDA Commissioner Marty Makary had sent last month to 22 Republican attorneys general who had called on the administration in July to conduct another review of the abortion drug. The letter stated that the federal government would do so.
“HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” they said in the letter.
In May, Kennedy directed the FDA to review its regulations for mifepristone.
And during his first few days in office, Trump issued an executive order to prevent federal funding from going toward elective abortions.
Kennedy’s review, which he said is based on reports of adverse effect in patients who took mifepristone, comes despite leading U.S. medical organizations, including the American College of Obstetricians and Gynecologists, stating complications associated with the medication are exceedingly rare, minor and most often easily treated.
The ACOG and other medical organizations have called for FDA approval of mifepristone to reflect “the rigorous clinical evidence that has proven unequivocally that it is safe and effective for use in medication abortion and miscarriage management.”
“Mifepristone is critical to patient care and should be accessible to those whose health and lives will benefit from it,” it said in a May statement following Kennedy’s directive for the FDA to review its regulations of the drug.
“Availability of mifepristone should reflect the overwhelming scientific evidence demonstrating that mifepristone is safe and effective.”
According to Guttmacher, 63% of all abortions provided by clinicians in the United States in 2023 were medication abortions.
The leading sexual health reproductive rights non-governmental organization states that at least 28 U.S. states restrict access to medication abortion, including 12 that also have total abortion bans.
Among those to voice anger over FDA’s approval of the generic abortion pill was Trump’s former vice president, Mike Pence, who said it was “a complete betrayal of the pro-life movement that elected President Trump.”
“Earlier this year, I opposed RFK’s nomination because he was unfit for the role and particularly over the concern that he would expand access to abortion, as he has done today,” he said on X.
“President Trump must immediately reverse this decision. RFK must resign and give President Trump the opportunity to appoint a new secretary of HHS who will protect the sanctity of life.”
Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony Pro-Life America nonprofit, described the FDA approval as “reckless” and “unconscionable,” and called on the Trump administration to end the policy that allows abortion pills to be mailed to patients.
“President Trump believes states have the right to pass and enforce pro-life protections. Yet, every day this right is being trampled upon by the abortion industry,” she said in a statement.