RFK Jr.: FDA has opened a ‘real-world’ safety review of abortion drug mifepristone

Health and Human Services Secretary Robert F. Kennedy Jr. told governors of conservative-leaning states that the Food and Drug Administration is conducting a safety review of the abortion drug mifepristone after reports of serious adverse effects.

Mr. Kennedy and FDA Commissioner Marty Makary wrote to 22 Republican attorneys general informing them of the review, which they said will examine “real-world outcomes and evidence, relating to the safety and efficacy of the drug.”

Mr. Kennedy is under pressure from Republican governors and lawmakers to increase restrictions on the drug and even pull it off the market.

Removing the drug, which is generally considered safe, would undermine President Trump’s campaign pledge to leave abortion access decisions up to the states.

Critics of the review say the Trump administration is hunting for a reason to restrict mifepristone, not out of safety concerns but to placate pro-life groups that want to block its use. It’s the most widely used method of abortion in the country.

“Let’s be clear: This is not about safety — this is the first step in banning abortion nationwide, even in states where it is currently protected,” said Mini Timmaraju, president of Reproductive Freedom for All. “Donald Trump, Robert F. Kennedy Jr. and Martin Makary are hijacking our government agencies to push a backdoor abortion ban. They are lying about their agenda, and this is proof. Mifepristone is safe, effective and essential. This is political interference designed to rip away our freedoms.”

Those pushing for the safety review say the government has gone too far in loosening restrictions on the drug.

Doctors began prescribing the mifepristone pill in 2000 to end early pregnancies and to manage miscarriages.

The FDA initially approved the drug for pregnant women up to seven weeks of gestation and added a list of safety requirements. The drug had to be prescribed and dispensed directly by a physician, and follow-up appointments with a doctor were required.

Doctors had to report adverse reactions.

By 2016, all the safety and reporting requirements had been dropped and the drug’s approval had been extended to include telehealth prescriptions for women up to 10 weeks of gestation.

Now, many women obtain the drug without seeing a doctor in person.

The drug works by blocking progesterone, a hormone necessary to support pregnancy, and is prescribed in combination with a second pill, misoprostol.

In July, attorneys general from 22 Republican-led states wrote to Mr. Kennedy and Dr. Makary, asking them to reinstate the dropped safety requirements and to consider “withdrawing mifepristone from the market until it completes its review and can decide on a course of action based on objective safety and efficacy criteria.”

The letter cited studies published in April and May by the conservative Ethics and Public Policy Center that reported “serious adverse events” for more than 1 in 10 women who took the drug, which is more than 22 times the rate that appears on the drug label and a failure rate double the reported rate on the drug label.

Adverse effects included sepsis, infection, hemorrhaging and surgery after failed abortions, as well as complications from ectopic pregnancies.

Abortion rights advocates say serious adverse effects are rare and that reinstating the safety requirements would significantly restrict access to the drug because it would require in-person doctor visits. About 25% of women who use the drug obtain it via telehealth.

In their letter sent Friday to the 22 attorneys general, Mr. Kennedy and Dr. Makary cited the Ethics and Public Policy Center study that found “potential dangers” associated with prescribing the drug “without sufficient medical support or supervision.”

Dr. Makary and Mr. Kennedy said the FDA collected data from 2000 to 2012 that found 2,740 adverse effects, among them 416 incidents that required blood transfusion.

“This administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” they wrote.