Journalists, bloggers and academics are weighing in on the FDA advisory panel that begins on Tuesday.
The single best thing I’ve read on the hearing is by Daniel Carpenter, a professor of government at Harvard who has a new book out about the FDA: Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Carpenter’s guest post on Pharmalot is a long, thoughtful analysis of the important issues that will be coming into play at this panel.
There’s no point in summarizing his ideas: Carpenter’s piece deserves to be read in its entirety. He eschews rhetoric and polemics in favor of a careful examination of the briefing documents in the light of a broader historical perspective on the FDA.
In the absence of technical problems CardioBrief is planning to live-blog and live-tweet the FDA hearing– or at least the more interesting parts. We’ll also keep you informed of other useful coverage of the hearing.
More reading:
- Glaxo on red alert as FDA scrutinises diabetes drug Avandia (The Guardian)
- Glaxo Withheld Avandia Study, Ex-Regulator Said to Testify (Bloomberg)
- FDA Faces Avandia Decision (Wall Street Journal)
- Six Reasons Avandia Could Stay On the Market (Forbes)
- Three Things To Remember During The Avandia Panel (Forbes)
- Avandia: When does a drug’s harm outweigh its benefit? (L.A. Times)
- A Guide to the Competing Storylines at the FDA’s Hearing on Glaxo’s Diabetes Drug (BNET)
CardioBrief invites readers to send links to other useful stories on the panel hearing, either via e-mail or the comments section.
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