Friday, September 25, 2009
FDA admits to something we already knew...
In a story published today by the New York Times, the FDA admits that it has made decisions based on influence from outside sources. This is should not be news to anyone who has followed the FDA over the years but the more information comes to light about the deficiencies of one of the agencies that are supposed to be protecting us from dangerous products, the better.
The NYT story, which is available here, specifically refers to the integrity of the FDA’s decision-making process for the approval of a device known as Menaflex. The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device was unsafe, but after receiving what an FDA report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey agency managers overruled the scientists and approved the device for sale.
Labels:
FDA,
Legislation and regulation,
Products liability
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