Senate Democrats demand answers on FDA abortion pill review

Senate Democrats warned the Trump administration against imposing additional restrictions on access to abortion pills in light of the Food and Drug Administration’s (FDA) "own review of the evidence” on the safety and effectiveness of mifepristone. 

In a letter sent Thursday to FDA and the Department of Health and Human Services, Sen. Patty Murray (D-Wash.) and the entire Senate Democratic Caucus warned the agencies not to “cherry-pick junk science serving an anti-abortion agenda” as they conduct the review.  

“We are alarmed by the Department’s obvious attempts to politicize the review, regulation, and approval of mifepristone at the FDA,” the Democrats wrote. 

The lawmakers in the letter took issue with a recent report put out by the Ethics and Public Policy Center (EPPC), a right-wing think tank, that appears to be the basis for the Trump administration’s announced review of mifepristone. 

“FDA relying on a partisan, sham report as part of the evidence review for any drug is deeply concerning—and in this case, it’s clear that the Trump administration is downright eager to do away with established science if it helps further their extreme anti-abortion agenda,” they wrote. 

That EPPC report, authored by people without medical training, found nearly 11 percent of women experienced sepsis, infection, hemorrhaging or “another serious adverse event” within 45 days of having an abortion using mifepristone. 

Mifepristone, which is taken with a second drug, misoprostol, to end an early pregnancy, was first approved by the FDA in 2000 after "a thorough and comprehensive review" determined it was safe and effective, the agency said. 

Administration health officials are under pressure from Republicans and anti-abortion groups to act on mifepristone access independent of the review, especially after FDA last month approved another generic version of the drug. They want the agency to reinstate an “in-person dispensing” requirement, among other restrictions.  

Democrats in the letter also called on the administration to follow a recent court order that found the current safety rules, such as a requirement for prescriber and pharmacy certification, to be "unreasoned, unsupported, and illogical.” 

A federal court in Hawaii ruled last month that the current risk evaluation and mitigation strategy (REMS) for mifepristone is unlawful because abortion pills are safe and effective. 

"That court order reinforces that, in conducting this new review, FDA may not cherry-pick junk science serving an anti-abortion agenda, but must instead look at the full body of evidence both confirming mifepristone’s safety and underscoring the harms of the FDA’s onerous restrictions,” the lawmakers wrote.