FDA delays mifepristone safety findings

The FDA said it expects to complete a safety study of the abortion pill mifepristone by mid-December this year. A report on findings is expected no later than March 2027.

What happens after the review

After the March 2027 report, the FDA will decide whether to impose new restrictions or other changes on mifepristone's use.

Hawley questions scope of review

Sen.Josh Hawley of Missouri expressed concern the FDA wasn't reviewing enough relevant data about potential adverse events.He asked acting FDA Commissioner Kyle Diamantas to confirm the review includes data from after 2023 restrictions were loosened.

Hawley wants mail data included

Hawley asked the FDA to ensure the review covers data from women who received mifepristone by mail after the Biden administration loosened restrictions in 2023 to make the drug more widely available.

Background on dispensing changes

In April 2021, the FDA announced it would not enforce its in-person dispensing requirement for mifepristone during the COVID-19 public health emergency.

Roy demands immediate release

Rep. Chip Roy of Texas sent a strongly worded letter demanding acting FDA Commissioner Kyle Diamantas release the study as soon as it is completed, rather than waiting until March to write a formal report.

Roy calls for advance commitment

Roy also called for the FDA to commit in advance to whether it intends to reinstate the in-person dispensing requirement for mifepristone. He threatened to reintroduce an amendment to FDA's appropriations bill.

Roy's threatened amendment

Roy threatened to reintroduce an amendment that would prohibit FDA funding from being used to administer the regulations allowing mifepristone to be mailed and dispensed in pharmacies.

Roy's warning to FDA

Roy wrote that House Republicans cannot be expected to continue funding the implementation of the January 2023 REMS modifications indefinitely while the FDA repeatedly extends its review without committing to corrective action.

“House Republicans cannot be expected to continue funding the implementation of the January 2023 REMS modifications indefinitely while FDA repeatedly extends its review without committing to corrective action.”

Roy on delay tactics

Roy stated that the need to complete a review cannot become a justification for indefinite delay. He is demanding the FDA commit to action before releasing its findings.

“The need to complete a review cannot become a justification for indefinite delay.”

Republicans threaten funding cuts

House Republicans are signalling they may cut FDA funding if the agency does not commit to reinstating in-person dispensing requirements for mifepristone and release its safety review sooner than March 2027.