FDA okays new generic abortion drug, outraging conservatives

Driving the news: The FDA last month approved a generic version of mifepristone made by Evita Solutions, which promoted it on the company's website this week.

• It's customarily a routine process that involves determining that a copycat drug matches the original version, in which the agency has limited discretion.
• But because mifepristone is used to terminate an early pregnancy, the approval of a new version is fraught with controversy.

What they're saying: Abortion opponents noted the move comes after Health Secretary Robert F. Kennedy Jr. and Makary told GOP attorneys general last month they were studying adding new safety limits to the drug, which had drawn praise from anti-abortion advocates.

• "FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they've just greenlighted new versions of it for distribution," Sen. Josh Hawley (R-Mo.) wrote on X. "I have lost confidence in the leadership at FDA."
• Susan B. Anthony Pro-Life America President Marjorie Dannenfelser called the decision "unconscionable."

The other side: "The FDA has very limited discretion in deciding whether to approve a generic drug," HHS spokesman Andrew Nixon told Axios when asked about the criticism.

• "By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug," he added.
• He also noted the agency is conducting a study of the safety risks of the drug.