STAT News, John Wilkerson & Ed Silverman, November 16, 2023
WASHINGTON — Principal Deputy FDA Commissioner Janet Woodcock will retire early next year from the Food and Drug Administration after helping steer the agency through an historic period of medical advances during nearly four decades in key leadership positions, she confirmed to STAT Thursday.
Woodcock, a doctor with a chemistry degree, joined FDA in 1986 at its biologics center, where she oversaw the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis. In 1994, she was named director of the drug center, where she played a key role in guiding some of the most impactful changes to the regulation of medicine, according to Trump administration FDA Commissioner Scott Gottlieb.
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But her time at the FDA was not without controversy. She was at the head of the agency for the controversial approval of the Alzheimer’s drug Aduhelm over the agency’s scientific advisers. A STAT investigation found that Aduhelm’s maker Biogen used an FDA backchannel to win approval. Government watchdog Public Citizen called for9 Woodcock’s resignation over it.
Diana Zuckerman, president of the National Center for Health Research, said Woodcock has been the most powerful person at the FDA for most of the last 15 years, and incoming commissioners have long relied on her deep knowledge of the agency. But Zuckerman also said approval standards have fallen too low under Woodcock’s leadership, tarnishing the FDA’s reputation.
“[H]er legacy also includes several disastrous decisions resulting in misinformation about oxycontin and other opioids,” she said. “She will definitely be remembered for insisting on unbelievably low approval standards for Exondys 51.”
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