(Reuters) -The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the agency under the Trump administration, its chief said. In an interview posted on a prominent industry blog, FDA commissioner Martin Makary also said there were no plans for major reorganization at the agency, […]
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US FDA chief says firings won’t hinder agency’s target dates for drug reviews
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(Reuters) -The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the agency under the Trump administration, its chief said.
In an interview posted on a prominent industry blog, FDA commissioner Martin Makary also said there were no plans for major reorganization at the agency, unlike those planned by Health and Human Services Secretary Robert F. Kennedy Jr. at its other health counterparts.
The FDA has laid off 3,500 employees under Kennedy’s massive restructuring of U.S. health agencies, raising questions over its impact on drug reviews.
“On the question of productivity, my center leaders have assured me that the FDA will reach its PDUFA (goal date) targets,” Makary said in an interview posted on the Inside Medicine Substack.
Reuters reported in early April that mass firings at the agency have removed employees critical to reviewing new medicines, including all staff responsible for managing records such as new product applications.
Makary also said that he could make independent decisions at the agency.
“No one above me has been or will be making decisions on products. Secretary Kennedy may have strong recommendations, which he has a right to, but I make my decisions based on the two guiding principles of gold standard science and common sense,” Makary added.
(Reporting by Manas Mishra in Bengaluru; Editing by Anil D’Silva)