onestepahead and Evil Rabbit,
You wrote about Dr. Woodcock's podcast and whether or not she should discuss Leronlimab. While I was looking for info on her podcast, I found this writeup which pointed out how naming a new FDA commissioner has become contentious. Expedited approval of Leronlimab should be a strong factor in her favor since the Biden administration has placed so much emphasis on Covid.
Link and excerpts below.
https://www.pharmexec.com/view/new-leadership...n-politics
The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. Consumer representatives have pressed to name Joshua Sharfstein to the job, a step up from serving as FDA principal deputy commissioner during the Obama administration; research and patient organizations seek to retain acting commissioner Janet Woodcock as permanent head of the agency. The administration’s inaction so far has set up the current situation as an unofficial trial period for Woodcock to display her leadership ability and political savvy as pressures continue for resolving the coronavirus pandemic.
A main claim against Woodcock is that she didn’t do enough to keep dangerous opioid treatments off the market in her long stint as director of the Center for Drug Evaluation and Research (CDER), and that she too often champions industry interests. Several leading scientists and consumer groups back Sharfstein as best able to balance public health with industry regulation.At the same time, more than 80 health and research organizations have called on Biden to name Woodcock to the top job based on her deep understanding of how the complex and vital agency works after 37 years at FDA. Sharfstein, previously Maryland public health commissioner and now a dean at Johns Hopkins University, appears more of a reformer, which makes industry nervous but pleases many Democrats.
Meanwhile, Woodcock is busy at FDA preparing policies to facilitate the speedy review and approval of revised vaccines and medical products to address rapidly spreading COVID-19 variants. FDA also is readying its analysis of the new COVID-19 vaccine from Johnson & Johnson in preparation for the upcoming advisory committee review hearing in two weeks, and more new coronavirus vaccines and therapies are moving through clinical testing. The use of Emergency Use Authorizations (EUAs) to permit patient access to these innovative treatments will face further scrutiny as the pandemic winds down.
At the same time, FDA is under continued pressure to meet timeframes for approving the many non-COVID medical products moving through the R&D pipeline and to address shortages in vital ingredients and medicines aggravated by the pandemic. A recent agency decision to put off approval of a controversial Alzheimer’s drug will have to be revisited. FDA also is in the midst of negotiating renewed user fees with industry, which have to be approved by Congress through legislation that regularly provides a vehicle for wide-ranging reforms and new FDA initiatives. Woodcock has long championed policies to modernize drug manufacturing and to create a more efficient and effective clinical research system in the U.S., and these efforts have gained added impetus from pandemic pressures.
You wrote about Dr. Woodcock's podcast and whether or not she should discuss Leronlimab. While I was looking for info on her podcast, I found this writeup which pointed out how naming a new FDA commissioner has become contentious. Expedited approval of Leronlimab should be a strong factor in her favor since the Biden administration has placed so much emphasis on Covid.
Link and excerpts below.
https://www.pharmexec.com/view/new-leadership...n-politics
The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. Consumer representatives have pressed to name Joshua Sharfstein to the job, a step up from serving as FDA principal deputy commissioner during the Obama administration; research and patient organizations seek to retain acting commissioner Janet Woodcock as permanent head of the agency. The administration’s inaction so far has set up the current situation as an unofficial trial period for Woodcock to display her leadership ability and political savvy as pressures continue for resolving the coronavirus pandemic.
A main claim against Woodcock is that she didn’t do enough to keep dangerous opioid treatments off the market in her long stint as director of the Center for Drug Evaluation and Research (CDER), and that she too often champions industry interests. Several leading scientists and consumer groups back Sharfstein as best able to balance public health with industry regulation.At the same time, more than 80 health and research organizations have called on Biden to name Woodcock to the top job based on her deep understanding of how the complex and vital agency works after 37 years at FDA. Sharfstein, previously Maryland public health commissioner and now a dean at Johns Hopkins University, appears more of a reformer, which makes industry nervous but pleases many Democrats.
Meanwhile, Woodcock is busy at FDA preparing policies to facilitate the speedy review and approval of revised vaccines and medical products to address rapidly spreading COVID-19 variants. FDA also is readying its analysis of the new COVID-19 vaccine from Johnson & Johnson in preparation for the upcoming advisory committee review hearing in two weeks, and more new coronavirus vaccines and therapies are moving through clinical testing. The use of Emergency Use Authorizations (EUAs) to permit patient access to these innovative treatments will face further scrutiny as the pandemic winds down.
At the same time, FDA is under continued pressure to meet timeframes for approving the many non-COVID medical products moving through the R&D pipeline and to address shortages in vital ingredients and medicines aggravated by the pandemic. A recent agency decision to put off approval of a controversial Alzheimer’s drug will have to be revisited. FDA also is in the midst of negotiating renewed user fees with industry, which have to be approved by Congress through legislation that regularly provides a vehicle for wide-ranging reforms and new FDA initiatives. Woodcock has long championed policies to modernize drug manufacturing and to create a more efficient and effective clinical research system in the U.S., and these efforts have gained added impetus from pandemic pressures.
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