FDA commissioner predicts ‘record’ drug approvals this year
The FDA Commissioner, Marty Makary, stated that drug approval processes this year are moving at a record pace despite layoffs at the Department of Health and Human Services. Speaking on CNBC’s Squawk Box, Makary assured that the FDA is on track to meet its review targets and may achieve a record number of drug approvals. He emphasized that over 1,000 scientists in the FDA’s research division remain strong and committed,with no layoffs affecting scientific reviewers or inspectors. Makary also addressed the recent resignation of Vinay Prasad, the top vaccine official, affirming that no single individual determines the success of the FDA’s scientific divisions. Since his appointment, Makary has accelerated the National priority Voucher program, reducing drug approval times significantly from 10-12 months to 1-2 months.
FDA commissioner predicts ‘record’ drug approvals this year
Food and Drug Administration Commissioner Marty Makary said approving drugs for human consumption is moving at a “record” pace.
Makary confirmed that the FDA’s review process will not slow down despite layoffs at the Department of Health and Human Services. During a Wednesday appearance on CNBC’s Squawk Box, he assured the public that the administration is approving products “on target” and could set a record.
“There’s over 1,000 scientists in that [research] division,” Makary said. “They’re phenomenal. They’re going to be strong. The FDA is going to meet all of its targets for review decisions this year. I think that we’re going to reduce the average time. We may hit a record number of approvals this year.”
Makary also responded to top FDA vaccine official Vinay Prasad’s resignation. Prasad was the director of the Center for Biologics Evaluation and Research and the administration’s chief medical and science officer, overseeing vaccine and gene therapy regulation.
FDA’S TOP VACCINE OFFICIAL VINAY PRASAD RESIGNS AFTER LOOMER CAMPAIGN AGAINST HIM
“To be clear, there were no reductions in force or layoffs of scientific reviewers or of inspectors at the FDA,” Makary said. “I think the FDA does not rest on any one individual, and no one person makes or breaks a scientific division.”
Since starting at the FDA this year, Makary has quickened the pace of the Commissioner’s National Priority Voucher program, reducing approval times from a 10- to 12-month wait to only one or two months.
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