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FDA rule would limit role of industry advisers
Doctors taking more than $50,000 from a drug or medical device company would be banned from voting on approval for that company's products if a new FDA rule becomes final. Physicians with such strong financial ties to a company whose products are under consideration--or ties to a competitor--would not be allowed to serve on the committees that make approval decisions. This represents a significant change from existing rules which, while they bar advisers holding $100,000 or more of stock in the company being discussed, could otherwise have accepted essentially unlimited funds. Agency officials have said that the new rules will affect a "significant number" of its current advisers. The new rules are intended to respond to charges that the agency's approval process is unduly influenced by the drug and device manufacturers it regulates.
To learn more about the proposed rules:
- read this article from The New York Times
Related Articles:
Pharma disclosure laws not working. Report
FDA boosts reviews for new drugs. Report
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