Difference between revisions of "Janet Woodcock"
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| + | |title=Director of the Center for Drug Evaluation and Research | ||
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| − | '''Janet Woodcock''' is a | + | '''Janet Woodcock''' is a civil servant in the [[Food and Drug Administration]]. In August 2021 as acting Commissioner of Food and Drugs, she gave the [[Pfizer–BioNTech COVID-19 vaccine]], so far administered under [[ emergency use authorization]], a permanent approval. |
| + | It seems she parachuted into the job only for the purpose of being a fall person for fully approving new COVID drugs and vaccines.<ref>https://www.fiercebiotech.com/biotech/after-aduhelm-fallout-fda-veteran-woodcock-out-running-for-commish-job-report</ref> | ||
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| + | Earlier in her career, she played a big part in the regulatory approval of [[opioids]], including for children ages 11 – 16, [[United States opioid epidemic|a practice that made addicts of and killed several hundreds of thousands Americans]]. | ||
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| + | ==Career== | ||
| + | Woodcock joined the U.S. [[Food and Drug Administration]] (FDA) in 1986. From May 1994 to April 2004 Woodcock served as Director of the Center for Drug Evaluation and Research (CDER) of the FDA, and again from January 2007 until April 12, 2021. | ||
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| + | In 2002, she led the <i>Pharmaceutical Quality for the 21st Century Initiative</i> using a risk based approach to "modernize" pharmaceutical manufacturing and [[regulation]].<ref>http://www.biopharminternational.com/drug-quality-center-stage-fda-and-manufacturers</ref> | ||
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| + | ==Opioids== | ||
As head of the [[Center for Drug Evaluation and Research]], the FDA department responsible for approving new prescription [[opioids]], she was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The FDA leadership has the authority to override the decisions of its advisory committees.<ref name=letter/> | As head of the [[Center for Drug Evaluation and Research]], the FDA department responsible for approving new prescription [[opioids]], she was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The FDA leadership has the authority to override the decisions of its advisory committees.<ref name=letter/> | ||
| − | A letter from | + | A January 2021 letter from a coalition of [[nonprofit]] advocacy groups stated that “recent reports that the [[Big Pharma|pharmaceutical industry]] enthusiastically supports Dr Woodcock’s candidacy for FDA Commissioner do not surprise us.”<ref name=letter/> |
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| + | She “consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis”.<ref name=letter>https://www.theguardian.com/us-news/2021/jan/28/fda-janet-woodcock-opioids-biden</ref> | ||
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| + | The letter accused Woodcock of “dereliction of duty” for allowing opioid manufacturers to spend years disseminating false claims that narcotic painkillers were less addictive and more effective than they really were, contributing to the rise of mass opioid prescribing.<ref name=letter/> | ||
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| + | It has earlier been revealed that FDA-officials responsible for opioid approvals were taking part in “pay to play” schemes where manufacturers paid tens of thousands of dollars to attend meetings to draw up the criteria for approving prescription narcotics.<ref name=letter/> | ||
==Pfizer–BioNTech COVID-19 vaccine== | ==Pfizer–BioNTech COVID-19 vaccine== | ||
Latest revision as of 11:42, 23 August 2021
 Janet Woodcock    (civil servant, health bureaucrat, Big pharma/Lobbyist) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
 | ||||||||||
| Born | August 29, 1948 | |||||||||
| Nationality | US | |||||||||
| Alma mater | Bucknell University, Northwestern University | |||||||||
| Spouse | Roger Miller | |||||||||
| Member of | Operation Warp Speed | |||||||||
Big Pharma civil servant responsible for the approval of opioid drugs, creating the United States opioid epidemic killing hundreds of thousands. In August 2021, responsible for giving permanent US approval of COVID-19 vaccines.
| ||||||||||
Janet Woodcock is a civil servant in the Food and Drug Administration. In August 2021 as acting Commissioner of Food and Drugs, she gave the Pfizer–BioNTech COVID-19 vaccine, so far administered under emergency use authorization, a permanent approval.
It seems she parachuted into the job only for the purpose of being a fall person for fully approving new COVID drugs and vaccines.[1]
Earlier in her career, she played a big part in the regulatory approval of opioids, including for children ages 11 – 16, a practice that made addicts of and killed several hundreds of thousands Americans.
Career
Woodcock joined the U.S. Food and Drug Administration (FDA) in 1986. From May 1994 to April 2004 Woodcock served as Director of the Center for Drug Evaluation and Research (CDER) of the FDA, and again from January 2007 until April 12, 2021.
In 2002, she led the Pharmaceutical Quality for the 21st Century Initiative using a risk based approach to "modernize" pharmaceutical manufacturing and regulation.[2]
Opioids
As head of the Center for Drug Evaluation and Research, the FDA department responsible for approving new prescription opioids, she was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The FDA leadership has the authority to override the decisions of its advisory committees.[3]
A January 2021 letter from a coalition of nonprofit advocacy groups stated that “recent reports that the pharmaceutical industry enthusiastically supports Dr Woodcock’s candidacy for FDA Commissioner do not surprise us.”[3]
She “consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis”.[3]
The letter accused Woodcock of “dereliction of duty” for allowing opioid manufacturers to spend years disseminating false claims that narcotic painkillers were less addictive and more effective than they really were, contributing to the rise of mass opioid prescribing.[3]
It has earlier been revealed that FDA-officials responsible for opioid approvals were taking part in “pay to play” schemes where manufacturers paid tens of thousands of dollars to attend meetings to draw up the criteria for approving prescription narcotics.[3]
Pfizer–BioNTech COVID-19 vaccine
In August 2021, it was reported she as acting head of the Food and Drug Administration, will give the Pfizer–BioNTech COVID-19 vaccine, so far administered under emergency use authorization, a permanent approval, making the push for mandatory vaccinations far more intensive.[4] She will not be nominated permanent head of the Food and Drug Administration.[5]
References
- ↑ https://www.fiercebiotech.com/biotech/after-aduhelm-fallout-fda-veteran-woodcock-out-running-for-commish-job-report
- ↑ http://www.biopharminternational.com/drug-quality-center-stage-fda-and-manufacturers
- ↑ a b c d e https://www.theguardian.com/us-news/2021/jan/28/fda-janet-woodcock-opioids-biden
- ↑ https://www.nytimes.com/live/2021/08/20/world/covid-delta-variant-vaccine
- ↑ https://www.bloomberg.com/news/articles/2021-08-19/janet-woodcock-ruled-out-for-permanent-fda-commissioner-post
