This past week saw the Food and Drug Administration (FDA) grant approval to a new generic version of the abortion pill mifepristone.
While some have accused Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. of betraying conservatives, Kennedy insists that his hands were tied.
HHS secretary posts statement to social media
As the Washington Examiner reported, Kennedy responded to criticism with a statement he released via social media on Friday.
“The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap,” Kennedy began.
“Last month, I joined [FDA Commissioner Marty Makary] in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on the safety of this drug,” he continued.
Kennedy points to 41-year-old law
“Recent studies already point to serious risks when mifepristone is used without proper medical oversight,” DHS secretary pointed out.
Kennedy concluded by stating that the FDA “only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”
The Examiner noted how the FDA’s approval process for generic drugs is regulated by U.S. Code 21.9.A. Sec. 355, which was established by the Hatch-Waxman Act in 1984.
It requires the FDA to find that a generic drug is the “pharmaceutical equivalent” of a name-brand drug which has already undergone a review process.
Josh Hawley accuses FDA head of lying to lawmakers
HHS spokesman Andrew Nixon was quoted as telling the Examiner that the FDA “has very limited discretion in deciding whether to approve a generic drug.”
“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 insisted.
Nixon went on to add that HHS is “conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”
Meanwhile, Missouri Republican Sen. Josh Hawley accused Makary of having “misled” senators during his confirmation hearing, asserting, “I don’t think [Kennedy] has to do with this, but the commissioner, yeah, I do.”
