FDA’s Abortion Pill Review Raises Concerns Among GOP Lawmakers

Congressional Republicans are questioning the Food and Drug Administration (FDA) following its recent disclosure regarding a safety review of the abortion drug mifepristone. The FDA has indicated that the review will not be publicly available until March.

The agency stated that the safety study should be completed by mid-December this year. The findings will be reported by March 2027, after which decisions regarding new restrictions on the drug’s use might be considered.

Mifepristone, paired with another drug, misoprostol, represents the most prevalent method of abortion in the U.S. Senator Josh Hawley (R-Mo.) expressed concerns in a letter that the FDA might not be examining enough relevant data, especially relating to adverse events. He queried if the review would include data gathered after the Biden administration loosened restrictions, making mifepristone available by mail in 2023.

In April 2021, the FDA announced it would not enforce the in-person dispensing requirement for mifepristone amid the COVID-19 emergency. By January 2023, modifications were made to the drug’s Risk Evaluation and Mitigation Strategy (REMS), allowing certified retail pharmacies to dispense it.

Representative Chip Roy (R-Texas) penned a strongly worded letter demanding quicker release of the study following its completion. He urged the FDA to clarify if it plans to reinstate the in-person dispensing requirement and threatened to reintroduce an amendment to restrict FDA funding for mailing and pharmacy dispersion regulations.

Roy underscored the urgency, stating, “The need to complete a review cannot become a justification for indefinite delay.”

Welcome to The Hill’s Healthcare newsletter. Each week, Nathaniel Weixel and Joseph Choi examine how Washington’s decisions impact your health.

Essential Reads

The healthcare sector faces significant impacts from policy changes this week and beyond:

• ObamaCare and other individual market health insurance plans saw a 4.5 million enrollment drop over the past year, marking an 18% decrease.
• Texas Attorney General Ken Paxton is suing Gerber Products Co. and Nestlé USA Inc., citing dangerous levels of toxic metals in Gerber baby food products.
• Senator Bill Cassidy (R-La.) criticized the Trump administration for not promoting vaccinations enough amidst a large measles outbreak, emphasizing the importance of measles vaccinations.

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Other News

In other news, Senator Thom Tillis (R-N.C.) is questioning Elon Musk regarding Ukraine’s restricted Starlink access.

Around the Nation

Key healthcare headlines from local and state news:

• California’s billionaire tax outlines healthcare relief amidst complicated details.
• A Texas woman is using state law to sue an anti-abortion group over allegedly ordering abortion pills online.
• Idaho advocates take the fight for abortion rights directly to their communities.

What We’re Reading

Highlighted health news from various outlets:

• Guinea-Bissau denies approval for a controversial vaccine trial in newborns (The Guardian).
• Walmart to offer benefits covering some GLP-1s, inhalers, and insulin for employees at no cost (CNBC).
• Lobbyists and trade groups seek influence over state regulations on medical AI (Stat).

You’re all caught up. See you tomorrow!