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Robert F. Kennedy Jr., President-elect Donald Trump’s nominee for Secretary of the Department of Health and Human Services, has made bold statements regarding the Food and Drug Administration (FDA) and its alleged corruption. Kennedy, who heads the Make America Healthy Again movement, aims to clean up what he perceives as conflicts between public health agencies and the pharmaceutical and food industries. He advocates for a return to a gold standard of scientific review within these agencies.
Kennedy’s stance on the FDA’s drug review process is unclear, but there are concerns that he may seek to roll back certain approaches that have been implemented in recent years to expedite the review process. This could include requiring at least two randomized controlled trials for drug approval and potentially limiting the use of accelerated approval mechanisms and emergency use authorizations.
President-elect Trump has also nominated Marty Makary to lead the FDA, with a focus on evaluating harmful chemicals in the food supply and drugs given to the nation’s youth. Makary shares Kennedy’s concerns about overmedication and the rising rates of chronic diseases in the U.S. Both nominees have been critical of the FDA’s ties to the pharmaceutical industry and could potentially push for changes to reduce the agency’s dependence on user fees paid by industry manufacturers.
The Prescription Drug User Fee Act (PDUFA), which provides funding for FDA drug review processes, could be a point of contention for Kennedy and Makary. While they may not have the power to unilaterally repeal PDUFA, they could advocate for changes to reduce the agency’s reliance on industry funding.
It remains to be seen how Kennedy and Makary’s leadership at the FDA could impact the drug approval process and public health agencies. Their potential focus on reducing industry influence and promoting a more rigorous scientific review process could have far-reaching implications for the future of healthcare in the United States.
