Why doesn't the FDA have a permanent commissioner?

"The FDA has played a critical role in this overdose epidemic by overseeing continuous approvals of stronger and more addictive opioids since the initial approval of OxyContin in 1995 - and Dr. Woodcock has been there for all of it" Manchin wrote in an open letter in June. In the 1960s, Fr...

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Veröffentlicht in:Managed Healthcare Executive 2021-11, Vol.31 (11), p.23-25
1. Verfasser: Kaplan, Deborah Abrams
Format: Artikel
Sprache:eng
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Zusammenfassung:"The FDA has played a critical role in this overdose epidemic by overseeing continuous approvals of stronger and more addictive opioids since the initial approval of OxyContin in 1995 - and Dr. Woodcock has been there for all of it" Manchin wrote in an open letter in June. In the 1960s, Frances Oldham Kelsey, an FDA reviewer, was responsible for keeping thalidomide, a morning sickness drug that caused birth defects, off the market in the U.S. But the agency started to work more closely with the pharmaceutical industry in the early 1990s partly because of the 1992 Prescription Drug User Fee Act, which, among other changes, set up a system of industry fees to support the agency's drug approval process in exchange for speeding up that process and setting deadlines. Aaron Kesselheim, M.D., J.D., M.P.H., a professor at Harvard Medical School and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women's Hospital in Boston, called the Aduhelm approval "probably the worst drug approval decision in recent U.S. history" in his resignation letter from the advisory committee that had recommended against approval. After the approval, Woodcock requested an investigation from the U.S. Department of Health & Human Services' Office of Inspector General, citing concerns about those contacts.
ISSN:1533-9300
2150-7120