RFK Jr. tells governors he’s reviewing abortion pill’s safety

Health and Human Services Secretary Robert F. Kennedy Jr. told red-state governors the Food and Drug Administration is conducting a safety review of the abortion drug mifepristone following reports of serious adverse effects in women who took the drug.

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 GOP governors and lawmakers to increase restrictions on the drug and even pull it off the market entirely.

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 anti-abortion groups that want to block its use. It’s the most widely utilized 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 drug was initially approved by the FDA for pregnant women up to seven week of gestation and came with a list of safety requirements. It had to be prescribed and dispensed directly by a physician, and follow-up appointments with a doctor were required for those who took the drug.

And doctors had to report adverse reactions.

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

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 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 one 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 advocates say serious adverse effects are rare and that reinstating the safety requirements will significantly restrict access to the drug because it would require in-person doctor visits. Currently, 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 also cited the EPPC study that found “potential dangers” associated with prescribing the drug “without sufficient medical support or supervision.”

The FDA, Mr. Makary and Mr. Kennedy said, collected data between 2000 and 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.