US EditionPublished • loading... • Updated
House lawmaker raises new concerns over FDA’s ultra-fast drug review program
Rep. Auchincloss demands transparency on financial disclosures for eight senior FDA officials amid concerns over legal authority and conflicts of interest in the expedited drug review program.
- In a letter Tuesday, Rep. Jake Auchincloss of Massachusetts questions whether the FDA had the legal authority to establish the voucher program without Congress, instructing the agency to `affirm or refute` his findings.
- The voucher program offers expedited reviews of one to two months for medicines supporting national interests, aligning with FDA Commissioner Marty Makary’s push to cut red tape and challenge assumptions.
- Auchincloss highlighted missing disclosures for eight senior FDA officials who vote on vouchers, noting financial disclosure forms are collected annually by the Office of Government Ethics.
- An FDA town hall was held Tuesday with three agency staffers, but the agency did not respond to Auchincloss’s new letter, and a Department of Health and Human Services spokesperson didn’t immediately answer questions; Auchincloss says FDA officials ignored two letters sent last year.
- In November, senators and representatives asked about 15 questions on the voucher program, while Rep. Jake Auchincloss says the FDA legal office `was not consulted nor provided findings` and calls for transparency due to political leadership at the FDA.
Insights by Ground AI
52 Articles
52 Articles
Auchincloss raises new concerns over FDA’s ultra-fast drug review program - The Boston Globe
Representative Jake Auchincloss of Massachusetts took issue with the agency’s handling of the program and questioned its legal underpinnings, noting that Congress did not sign off on the plan.
·Boston, United States
Read Full Article
Associated Press News+50 Reposted by 50 other sources
House lawmaker raises new concerns over FDA's ultra-fast drug review program
A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs.
·United States
Read Full ArticleCoverage Details
Total News Sources52
Leaning Left8Leaning Right4Center35Last UpdatedBias Distribution74% Center
Bias Distribution
- 74% of the sources are Center
74% Center
L 17%
C 74%
Factuality
To view factuality data please Upgrade to Premium
