Trump administration approval of new abortion drug infuriates the right

The Trump administration has approved a new generic version of the mifepristone abortion pill, a decision made quietly by the Food and Drug Administration this week that is now prompting uproar among anti-abortion leaders.

The administration’s approval of the drug on Tuesday comes less than two weeks after Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary said the department was conducting a review of the safety of abortion pills, a decision that anti-abortion activists welcomed.

Now, those same leaders are questioning the administration’s commitment to their cause, marking the first significant pushback Trump has received from his otherwise loyal base of socially conservative activists.

“This is a wildly disappointing decision. We are extraordinarily disappointed,” said Kristi Hamrick, vice president of media and policy for Students for Life of America, in an interview with The Washington Post. “This has to be addressed.”

Hamrick referred to the FDA’s decision as “the opposite of the gold standard review” that anti-abortion leaders believed the Trump administration was conducting into mifepristone, and is among the activists questioning why FDA would green-light the approval before launching the safety study.

“This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable,” said Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America.

Sen. Josh Hawley (R-Mo.) said in a social media post about the decision that he has “lost confidence in the leadership at FDA.” Former Vice President Mike Pence said the decision was “a complete betrayal of the pro-life movement that elected President Trump” and called on Kennedy to be fired.

A White House spokesman did not respond to questions about Trump’s position on the drug approval but provided a statement from HHS spokesman Andrew Nixon, who said the FDA “has very limited discretion in deciding whether to approve a generic drug.”

Nixon said the HHS secretary, by law, must approve an application if it demonstrates that the generic drug is identical to the brand-name drug, and generic applications aren’t required to provide evidence proving safety or effectiveness. He noted that 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 does not endorse any drug product and directs prescribers to follow all labeling,” Nixon continued.

The drug application in question was submitted by Evita Solutions LLC on Oct. 1, 2021, and the approval took effect on Tuesday, according to a letter the FDA sent to the company. Anti-abortion activists were quick to note that the company’s mission statement says it exists to recognize “the utility and freedom that medical abortion provides patients” and to “normalize abortion.”

Some top anti-abortion activists in recent days had gotten wind of an expected approval of the drug and had begun sounding alarms on Capitol Hill, according to two people with knowledge of those conversations. It’s unclear whether the White House was aware of the pending approval.

Anti-abortion activists focused in recent years on mifepristone, a drug now used in more than six in 10 of all abortions nationwide. Women have increasingly used it to terminate pregnancies, especially in states that banned abortion after the Supreme Court struck Roe v. Wade in 2022.

Sixteen states have near-total abortion bans, according to the Guttmacher Institute, which supports abortion rights. But groups providing abortion pills still mail them to women in many states with bans, prompting a massive legal battle over whether states can criminalize the mailing of an FDA-approved drug.

The FDA cited a large body of research showing mifepristone is safe and effective when it first approved the drug more than two decades ago.

Conservative activists have pushed the Trump administration to reinstate stricter rules around how and when the drug can be dispensed. The Obama and Biden administrations had relaxed those rules, allowing it to be prescribed later in the pregnancy and without an in-person doctor visit.

Last month, Kennedy and Makary wrote to 22 Republican state attorneys general — who had asked FDA to take another look at mifepristone — saying the agency would conduct a fresh review of the drug’s safety and efficacy.

They cited a study released over the summer by the Ethics and Public Policy Commission, which used insurance claim data to claim more woman are experiencing adverse effects from the drug than previously thought. Abortion rights advocates have noted the study wasn’t peer-reviewed.