Senate Democrats warned the Trump administration that they’ll be watching closely to ensure that the Food and Drug Administration doesn’t “cherry-pick junk science serving an anti-abortion agenda” as it reviews access to abortion pills.
In a letter sent Thursday and obtained by NOTUS, the Senate Democratic Caucus called on the administration to follow a recent court order that found restrictions on the abortion medication mifepristone to be unlawful.
“We are alarmed by the Department’s obvious attempts to politicize the review, regulation, and approval of mifepristone at the FDA,” the senators, led by Sen. Patty Murray, wrote in the letter to Health and Human Services Secretary Robert F. Kennedy and FDA Commissioner Marty Makary.
Sign Up for NOTUS’ Free Daily Newsletter
Trending
A federal court in Hawaii ruled last month that the current conditions to obtain mifepristone are “burdensome” and “unwarranted” because abortion pills are safe and effective. Providers must be certified to dispense mifepristone, patients and providers must sign documentation to access it and pharmacies must be qualified to sell it — all of which can make it more difficult to access.
Mifepristone is considered safe and effective by leading medical organizations. The conditions on its distribution are rare: 99.5% of drugs regulated by the FDA do not have similar conditions imposed on them, according to the American College of Obstetricians and Gynecologists.
U.S. District Judge Jill A. Otake said the FDA acted “arbitrarily and capriciously” when it failed to consider a prominent Canadian study published in The New England Journal of Medicine, which found that no increase in abortion-related complications resulted from removing restrictions from mifepristone and allowing it to be available as a normal prescription.
The judge said the FDA must reconsider the restrictions attached to its authorization of mifepristone.
The Senate Democrats wrote that the administration “must instead look at the full body of evidence both confirming mifepristone’s safety and underscoring the harms of the FDA’s onerous restrictions.”
Democrats fear that the Trump administration will instead rely on a report by the conservative Ethics and Public Policy Center that says nearly 11% of women experienced sepsis, infection, hemorrhaging or “another serious adverse event” within 45 days of having an abortion using mifepristone.
Anti-abortion leaders are aggressively backing that report, which was not peer-reviewed or published in a scientific journal. Kennedy cited it in September to say that there were “potential dangers” when “offering mifepristone without sufficient medical support or supervision.”
“The FDA should be using gold-standard science and evidence when making decisions about medication access for the American people,” Senate Democrats wrote in their letter. “FDA relying on a partisan, sham report as part of the evidence review for any drug is deeply concerning.”
Democrats are demanding that the Trump administration respond by Nov. 28 and explain what evidence prompted the FDA to conduct a new review of mifepristone, how the review will be conducted, under what standards they’re reviewing assessing data, whether HHS has additional data on on adverse events and how the agency plans to follow Otake’s court order.
Author
