Sen. Manchin to Biden: Don't nominate Woodcock for FDA commissioner
While Sen. Joe Manchin’s opposition to Janet Woodcock as Biden’s choice for FDA commissioner has been known for months, the West Virginia Democrat spelled out more detailed concerns in a new letter to President Biden on Thursday.
“Dr. Woodcock is not the right person to lead the FDA,” Manchin, an influential centrist, writes, while noting the agency has been without permanent leadership for about five months.
Manchin raises the example of the recent accelerated approval for Biogen’s Alzheimer’s drug, which Woodcock has since said she was not a part of, and how the agency has yet to explain why it went against its advisory committee’s near-unanimous recommendations to reject the drug, while noting that three of those adcomm members have since resigned.
Woodcock has remained mostly silent on the approval, although she told BioCentury recently that she thought the data on amyloid clearing “were quite solid.” The nonprofit watchdog Public Citizen has called for Woodcock to resign over the approval.
The opioid epidemic and Covid-19 are also top of mind for Manchin as he raises concerns that without a permanent, Senate-confirmed FDA commissioner, important decisions that impact the country’s response to Covid-19 “will be slowed and prevent additional work to combat the ongoing drug overdose epidemic.”
Manchin makes clear that the FDA has played a critical role in this overdose epidemic, but not in a good way. “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. Dr. Woodcock has repeatedly ignored public health concerns and shown a dereliction of duty by not working to end this epidemic,” Manchin writes.
The decision for Manchin, who has deep ties to the biopharma industry as his daughter served as CEO of Mylan, to be more public about his concerns with Woodcock comes as at least three other Senate Democrats – Maggie Hassan of New Hampshire, Ed Markey of Massachusetts, and Catherine Cortez Masto of Nevada – have pre-empted Biden’s nomination and voiced their opposition to Woodcock, who by all indications is still the leading contender for the job.
Those Democrats voting against a potential Woodcock nomination may not end up mattering much because she may win over some Republican votes, not only because of the approval of Biogen’s Aduhelm, which several Republicans have since praised, but also because of her experience working for the Trump administration’s Operation Warp Speed as head of therapeutics.
When exactly Biden’s nomination may occur remains unknown. HHS Secretary Xavier Becerra told Bloomberg Law Wednesday that Biden will make the nomination once the busy president finds time.
https://endpts.com/sen-manchin-to-biden-dont-...missioner/
While Sen. Joe Manchin’s opposition to Janet Woodcock as Biden’s choice for FDA commissioner has been known for months, the West Virginia Democrat spelled out more detailed concerns in a new letter to President Biden on Thursday.
“Dr. Woodcock is not the right person to lead the FDA,” Manchin, an influential centrist, writes, while noting the agency has been without permanent leadership for about five months.
Manchin raises the example of the recent accelerated approval for Biogen’s Alzheimer’s drug, which Woodcock has since said she was not a part of, and how the agency has yet to explain why it went against its advisory committee’s near-unanimous recommendations to reject the drug, while noting that three of those adcomm members have since resigned.
Woodcock has remained mostly silent on the approval, although she told BioCentury recently that she thought the data on amyloid clearing “were quite solid.” The nonprofit watchdog Public Citizen has called for Woodcock to resign over the approval.
The opioid epidemic and Covid-19 are also top of mind for Manchin as he raises concerns that without a permanent, Senate-confirmed FDA commissioner, important decisions that impact the country’s response to Covid-19 “will be slowed and prevent additional work to combat the ongoing drug overdose epidemic.”
Manchin makes clear that the FDA has played a critical role in this overdose epidemic, but not in a good way. “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. Dr. Woodcock has repeatedly ignored public health concerns and shown a dereliction of duty by not working to end this epidemic,” Manchin writes.
The decision for Manchin, who has deep ties to the biopharma industry as his daughter served as CEO of Mylan, to be more public about his concerns with Woodcock comes as at least three other Senate Democrats – Maggie Hassan of New Hampshire, Ed Markey of Massachusetts, and Catherine Cortez Masto of Nevada – have pre-empted Biden’s nomination and voiced their opposition to Woodcock, who by all indications is still the leading contender for the job.
Those Democrats voting against a potential Woodcock nomination may not end up mattering much because she may win over some Republican votes, not only because of the approval of Biogen’s Aduhelm, which several Republicans have since praised, but also because of her experience working for the Trump administration’s Operation Warp Speed as head of therapeutics.
When exactly Biden’s nomination may occur remains unknown. HHS Secretary Xavier Becerra told Bloomberg Law Wednesday that Biden will make the nomination once the busy president finds time.
https://endpts.com/sen-manchin-to-biden-dont-...missioner/
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