- While Senator Joe Manchin has been vocal on his opposition to Janet Woodcock as Biden’s choice for FDA commissioner, he spelled out detailed concerns in a letter to President Biden.
- “Dr. Woodcock is not the right person to lead the FDA,” Manchin writes, while noting the agency has been without permanent leadership for about five months.
- The senator raises the example of the recent accelerated approval for Biogen Inc’s BIIB Alzheimer’s drug, which Woodcock has since said she was not a part of, and the agency has yet to give reasons on why it went against its advisory committee’s recommendations to reject the drug.
- He also noted that three of those adcomm members have since resigned.
- The nonprofit watchdog Public Citizen has called for Woodcock to resign over the approval in a letter to HHS Secretary Xavier Becerra.
- In 2020, over 90,000 Americans died from drug-related overdoses, which is the highest year of overdose deaths ever recorded.
- Manchin clarifies that the FDA has played a critical role in this overdose epidemic, but not in a good way. “By overseeing continuous approvals of more potent and more addictive opioids since the initial approval of OxyContin in 1995 – and Dr. Woodcock has been there for all of it.
- Dr. Woodcock has repeatedly ignored public health concerns and shown a dereliction of duty by not working to end this epidemic,” Manchin writes.
- When exactly Biden’s nomination may occur remains unknown. HHS Secretary Xavier Becerra told Bloomberg Law that Biden would nominate once the busy president finds time.
- Image Courtesy: Wikimedia
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