"New research shows testimony given at those meetings in recent years overwhelmingly supports drug approval, and nearly half of speakers report some kind of conflict of interest. This raises obvious questions about who gets to speak, why, and how much influence these individuals have on final FDA decisions. In a two-year project sponsored by The Greenwall Foundation, researchers affiliated with Brigham and Women's Hospital's Program on Regulation, Therapeutics, and Law (PORTAL) and Harvard Medical School are seeking to answer these questions."
"Why is this topic important to study? We live in a democracy, so it seems important that people participate in regulation. But the FDA is making highly technical decisions, which raises the question of whether there should be public input and what to do with the information that people offer. 'There's a lot of uncertainty about the FDA process and whose voice is weighing in on decisions that affect the public's health.'"
Public input plays a key role in the drug approval process through hearings before FDA advisory committees. Recent research found that public testimony at those meetings has overwhelmingly supported drug approval. Nearly half of public speakers report some form of conflict of interest. These patterns prompt questions about who is permitted to speak, why detracting voices are scarce, and how testimonial input influences FDA decisions. A two-year study by researchers affiliated with PORTAL and Harvard Medical School seeks to investigate these dynamics and the decline in advisory committee meetings.
Read at Harvard Gazette
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