FDA advisory committee meetings fade as controversial decisions grow
WASHINGTON — On Thursday, the Trump administration organized a private press conference so that a senior Food and Drug Administration official could anonymously criticize an experimental Huntington’s disease treatment made by the company UniQure.
In the past, when faced with a controversial regulatory matter, the agency would often organize public gatherings with an independent panel of advisors, known in industry parlance as an advisory committee meeting, or adcomm. Patients, doctors, and other interested parties were given an opportunity to comment. They gained a transparent look inside the scientific dialogue between company leaders and regulators, who would present their own analysis of applications for medical product approvals.
UniQure announced last fall that a clinical trial showed its treatment dramatically slowed the progression of Huntington’s disease. The company seemed confident it could apply for approval. Then, the FDA said it wasn’t convinced.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
To read the rest of this story subscribe to STAT+.
First Appeared on
Source link
