RFK Jr. Pledge to Review Abortion Pill Draws Quick Criticism (1)

Health Secretary Robert F. Kennedy Jr.'s call to review a decades-old drug used for abortion received swift pushback from critics who say the effort is based on bad information and is a threat to an increasingly endangered reproductive rights landscape.

Kennedy agreed with a senator on Wednesday that a recent study from a conservative think tank, the Ethics & Public Policy Center, warrants a review of the abortion drug mifepristone.

The fight around mifepristone sits at the center of the reproductive rights landscape. Anti-abortion advocates have fought in courts and on the policy front to have the Food and Drug Administration revisit its safety determination of the drug.

The EPPC bills the study as the “largest-known” on the abortion pill and says it found that one in 10 users had a significant adverse health event from the drug. But Kennedy’s remarks spurred quick responses from abortion activists, health experts, and others who say the study is methodologically flawed, goes against long-accepted science on the drug, and is merely another tool in the ongoing effort to block access to medication abortion.

“The obvious goal is to change FDA policy to make it even harder for people across the country to get an abortion,” said Julia Kaye, senior staff attorney with the ACLU’s Reproductive Freedom Project, during a Thursday press call.

“We know this review is not about science or safety because the safety of medication abortion has already been proven by more than a hundred high-quality studies and data from millions of patient uses over decades,” Kaye said.

But Ryan Anderson, the policy center’s president, said in a statement, “We encourage the FDA to conduct its own study to best ensure that women are given an honest and clear presentation of the dangers of the abortion pill.”

Legal Efforts

Kennedy’s announcement to consider a review comes as over 40 states have put into effect abortion bans with limited exceptions, according to a Guttmacher Institute update from late March. Medication abortion is likely under threat in states as well; as of late April, Guttmacher data shows 28 states restrict medication abortion access.

“We are encouraged that the Trump administration will review the poor safety record of mifepristone, and we hope that the FDA will change course for the sake of all women,” Erik Baptist, senior counsel at the Alliance Defending Freedom, said in a statement.

ADF, a Christian legal group, backed a lawsuit against the Biden administration’s FDA over safety decisions on mifepristone. After a trip to the US Supreme Court, where the justices ruled the groups behind the case didn’t have standing to sue, the fight went back to a lower court, where conservative states are currently trying to curtail access to the drug.

“Since 2016, the FDA’s own label has warned that roughly 1 in 25 women who take abortion drugs will end up in the ER. But the Biden FDA’s politically motivated decision to create a nationwide mail-order abortion drug regime has put women in even more danger,” Baptist said.

“The FDA anticipated that even more women and girls would end up in the ER upon authorizing mail-order abortion drugs, while also acknowledging that the studies on which it relied were ‘not adequate’ to show it was safe to mail these drugs without an office visit,” he said.

Earlier this month, the Trump administration filed an update in the mifepristone litigation, arguing that the battle should be tossed or transferred to a different court as the states now fighting over mifepristone—Idaho, Missouri and Kansas—don’t have ties to the Texas jurisdiction.

In the filing, however, the Trump administration didn’t put forth its views on mifepristone access. Observers say the Trump administration is trying to keep its options open on how to handle the politically sensitive issue of medication abortion.

Need for Review

Kennedy’s Wednesday remarks came as part of a Senate Health, Education, Labor and Pensions Committee hearing over the Trump administration’s budget request for the Department of Health and Human Services.

Sen. Josh Hawley (R-Mo.), whose wife was an ADF attorney in the mifepristone case before the Supreme Court, told Kennedy that the “new data” from the EPPC “indicates that at very least the label should be changed” for mifepristone.

In April, FDA Commissioner Marty Makary said he didn’t have plans to change government policy on mifepristone, though he noted he would reconsider if new data emerged.

Kennedy on Wednesday responded to Hawley that he’d asked Makary to do the “complete review and to report back.”

Health and policy experts argue the review is unnecessary.

“More than seven and a half million patients have used mifepristone to end pregnancy since the FDA first approved the medication in 2000, and more than a hundred high quality studies confirm its safety and efficacy,” Ushma Upadhyay, public health scientist and professor at the University of California, San Francisco, said at the Thursday press conference.

Upadhyay also noted that the EPPC report “was neither peer reviewed nor published in a scientific journal,” and that her own review found “that they used flawed methodology which artificially and inaccurately inflated the risks of mifepristone,” such as counting any emergency room visit, even if a patient was fine and released without treatment.

Dale Cecka, director of the Family Violence Litigation Clinic at Albany Law School, echoed this sentiment in a statement to Bloomberg Law. She said Kennedy was “hucking junk science and using fear mongering to perpetrate lies about one of the safest drugs on the market in women’s reproductive health.”

“Mifepristone is a crucial medication for treating unexpected complications from pregnancy, not just prevention, and without it, more women will die,” Cecka said.