Scientific Integrity Policy Updates At FDA, CDC Due For Completion In July
HHS-wide update will address agency integrity improvements in the wake of concerns that political considerations inappropriately influenced regulatory decisions related to COVID-19 during the Trump Administration, the General Accountability Office notes in a new report.
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Former agency heads and outside experts suggest structural reforms in interviews with GAO. Report notes FDA had 10 political appointees in 2020 versus 5 in 2016 and 3 in 2022. House Select Subcommittee on the Coronavirus Crisis describes Trump Administration actions against FDA in its final report.
CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.
Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.