Post by icemandios on Jan 12, 2022 16:44:19 GMT
Woodcock defends FDA's response to Omicron before Senate health committee
Zachary Brennan
Senior Editor
In what may be Janet Woodcock’s final congressional hearing as the head of the FDA, she once again offered a candid description of the difficulties of battling the current Omicron outbreak.
Speaking through two masks alongside other CDC, NIH and HHS leaders, Woodcock compared the current pandemic to a natural disaster, adding, “I don’t think it will last a really long time.”
“I think we need to focus on continuity of operations for hospitals,” she said in response to questions from Sen. Mike Braun (R-IN) at the Senate Health, Education, Labor and Pensions Committee meeting on Tuesday. “I think it’s hard to process what’s actually happening right now, which is that most people are going to get Covid.”
She stressed the need to make sure the hospitals, transportation and other essential services aren’t disrupted and after that, she said, it’ll be important to reassess what has been done and needs to be improved upon.
“There’s an extreme unmet medical need for therapeutics at most stages of the disease, particularly in the late stages, where we still don’t have interventions and people are dying, going into the ICU and going on the ventilator,” Woodcock said, noting there are 670 INDs that are ongoing. “Robust development is still ongoing in the therapeutic area.”
In questioning related to the FDA’s authorization of rapid tests, which has come under fire — as many senators lamented the woefully inadequate rapid test supplies — Woodcock said it was more of an issue of manufacturing capacity versus the authorization process.
In her written testimony, Woodcock noted that the FDA’s actions have reduced the review times for tests “from a peak average of 90 days for EUA requests received in September 2020 to approximately 35 days for those received since February 2021.”
“We could do more with more resources,” she said. “It’s an incredible increase in workload,” she said of the tests, while praising the NIH’s standardization work that accelerates the authorization of some new tests, sometimes to as quickly as two days, Woodcock said.
Republicans like ranking member Richard Burr criticized President Biden’s announcement about boosters for all prior to FDA authorization, and then the FDA’s adcomm had to “bend to the whims of the political decision already made,” which he said created skepticism and confusion with the launch of boosters.
“Now we’re begging people to get boosters, which is where we should’ve been on Day 1,” Burr said.
Woodcock testified that the vaccines authorized remain highly effective against preventing hospitalization and death, and an additional booster provides further protection.
As she wraps up her opening statement, @drwoodcockfda says that “FDA is committed to continuing to use every tool in our toolbox to fight this pandemic.” pic.twitter.com/0aSAjxxCHl
— U.S. FDA (@us_FDA) January 11, 2022
Sen. Mitt Romney (R-UT) also criticized the Biden administration for not building enough testing capacity and aggressively ramping up production, while Sen. Susan Collins (R-ME) questioned what ASPR has done with more than $80 billion appropriated for tests, and test production, when “no one can find a rapid test when they need them.”
“This crisis is entirely preventable. The fact is that the administration failed to anticipate our testing needs,” she added.
ASPR head Dawn O’Connell explained that the testing money has been used for testing, and she mentioned that some funds were used to test children crossing the border.
Zachary Brennan
Senior Editor
In what may be Janet Woodcock’s final congressional hearing as the head of the FDA, she once again offered a candid description of the difficulties of battling the current Omicron outbreak.
Speaking through two masks alongside other CDC, NIH and HHS leaders, Woodcock compared the current pandemic to a natural disaster, adding, “I don’t think it will last a really long time.”
“I think we need to focus on continuity of operations for hospitals,” she said in response to questions from Sen. Mike Braun (R-IN) at the Senate Health, Education, Labor and Pensions Committee meeting on Tuesday. “I think it’s hard to process what’s actually happening right now, which is that most people are going to get Covid.”
She stressed the need to make sure the hospitals, transportation and other essential services aren’t disrupted and after that, she said, it’ll be important to reassess what has been done and needs to be improved upon.
“There’s an extreme unmet medical need for therapeutics at most stages of the disease, particularly in the late stages, where we still don’t have interventions and people are dying, going into the ICU and going on the ventilator,” Woodcock said, noting there are 670 INDs that are ongoing. “Robust development is still ongoing in the therapeutic area.”
In questioning related to the FDA’s authorization of rapid tests, which has come under fire — as many senators lamented the woefully inadequate rapid test supplies — Woodcock said it was more of an issue of manufacturing capacity versus the authorization process.
In her written testimony, Woodcock noted that the FDA’s actions have reduced the review times for tests “from a peak average of 90 days for EUA requests received in September 2020 to approximately 35 days for those received since February 2021.”
“We could do more with more resources,” she said. “It’s an incredible increase in workload,” she said of the tests, while praising the NIH’s standardization work that accelerates the authorization of some new tests, sometimes to as quickly as two days, Woodcock said.
Republicans like ranking member Richard Burr criticized President Biden’s announcement about boosters for all prior to FDA authorization, and then the FDA’s adcomm had to “bend to the whims of the political decision already made,” which he said created skepticism and confusion with the launch of boosters.
“Now we’re begging people to get boosters, which is where we should’ve been on Day 1,” Burr said.
Woodcock testified that the vaccines authorized remain highly effective against preventing hospitalization and death, and an additional booster provides further protection.
As she wraps up her opening statement, @drwoodcockfda says that “FDA is committed to continuing to use every tool in our toolbox to fight this pandemic.” pic.twitter.com/0aSAjxxCHl
— U.S. FDA (@us_FDA) January 11, 2022
Sen. Mitt Romney (R-UT) also criticized the Biden administration for not building enough testing capacity and aggressively ramping up production, while Sen. Susan Collins (R-ME) questioned what ASPR has done with more than $80 billion appropriated for tests, and test production, when “no one can find a rapid test when they need them.”
“This crisis is entirely preventable. The fact is that the administration failed to anticipate our testing needs,” she added.
ASPR head Dawn O’Connell explained that the testing money has been used for testing, and she mentioned that some funds were used to test children crossing the border.