Overview
- In a letter sent Thursday, the entire Senate Democratic Caucus urged HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to follow a federal court order and avoid “cherry-picking junk science.”
- The Democrats warned against relying on a report from the Ethics and Public Policy Center that claims nearly 11% serious adverse events, noting it was not peer-reviewed and was authored by individuals without medical training.
- A U.S. District Court in Hawaii last month found the FDA’s mifepristone safety rules unlawful, calling them burdensome and unreasoned, and ordered the agency to reconsider after it failed to weigh a NEJM Canadian study showing no increase in complications when restrictions were lifted.
- The letter requests an explanation by Nov. 28 of what evidence prompted the FDA’s new review, how the assessment will be conducted, what standards will apply, and whether HHS has additional adverse-event data.
- Republicans and anti-abortion groups continue to push for tighter controls, including reinstating in-person dispensing, following the FDA’s recent approval of another generic version of mifepristone.