FDA abortion pill review angers GOP lawmakers

FDA abortion pill review angers GOP lawmakers

Congressional Republicans have some pointed questions for the Food and Drug Administration (FDA), following the agency’s recent disclosure that a safety review of the abortion drug mifepristone won’t be public until March .

The FDA said in a court filing last week that it expects to complete a safety study of the pill by mid-December this year . A report on the findings is expected “no later than March 2027,” after which the agency will decide whether to impose new restrictions or other changes on the drug’s use.

The two-drug regimen of mifepristone, combined with a second drug misoprostol, is the most common form of abortion in the U.S.

Sen. Josh Hawley (R-Mo.) in a letter said he was concerned the FDA wasn’t reviewing enough relevant data about potential adverse events.

He asked acting FDA Commissioner Kyle Diamantas to confirm that the review will include data from the period after the Biden administration loosened restrictions to make mifepristone more widely available in 2023, to make sure it covers data from women who have received the drug by mail.

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

In January 2023, it formally modified the mifepristone REMS (Risk Evaluation and Mitigation Strategy) to eliminate in-person dispensing and to allow certified retail pharmacies to dispense the drug.

Rep. Chip Roy (R-Texas) sent a much more strongly worded letter Wednesday, demanding Diamantas release the study as soon as it is completed , rather than waiting until March to write a formal report. He also called for FDA to commit to say in advance whether intends to reinstate the in-person dispensing requirement.

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

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

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Local and state headlines on healthcare:

California’s billionaire tax promises healthcare relief. The fine print is murkier ( KFF Health News )

Texas woman uses state law to sue anti-abortion group that allegedly ordered abortion pills online ( Texas Tribune )

Idaho moms and grandmothers are taking the fight for abortion rights to their neighbors’ doors ( The 19th)

Health news we’ve flagged from other outlets:

Guinea-Bissau denies it has approved controversial vaccine trial in newborns ( The Guardian )

Walmart to cover some GLP-1s, inhalers and insulin for employees at no cost as it expands benefits ( CNBC )

Lobbyists and trade groups fight to shape how states regulate medical AI ( Stat )

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