FDA – another example of “soft corruption”
Just how does the Food and Drug Administration decide what drugs or devices to approve for use by the public?
These decisions are made by FDA Advisory Committees made up of experts in the field.
Today’s New York Times (22 March, 2007) has an article F.D.A. Rule Limits Role of Advisors Tied to Industry which says that advisory committee members will (for the first time) be barred from voting on approval for a company’s product if they have received money from that company or a competitor. And if they have received more than $50,000 from that company or a competitor within the last 12 months then they cannot serve on a committee judging that company’s products (less than $50k is just hunky dory 
).
FDA Acting Deputy Commissioner Randall W. Lutter stated that a “signficant number” of the agency’s current advisers would be affected by this policy.
What that means, of course, is that up until now, many of the people responsible for approving drugs and medical devices have been routinely accepting tens of thousands of dollars a year from the company’s whose products they were approving. Smells a just a bit, don’t you think?
The article describes a situation in 2005 where 10 of the advisers who voted for Bextra to remain on the market and Vioxx to return to the market had accepted tens of thousands of dollars from the manufacturers. If the tainted advisors had not been allowed to vote, the products would not have been allowed back on the market since the majority of advisers who had not accepted money had voted against approval.
Other little tidbits from the article; under FDA rules an adviser cannot vote if they hold more than $100,000 in stock in the manufacturer (but holding $99,000 or less is hunky dory ).
One needs to remember that the previous FDA Commissioner, Lester Crawford, recently pleaded guilty to charges of filing false financial disclosure forms and conflicts of interest. The government had charged that Crawford and his wife owned stock in several companies that fell under FDA regulation, and failed to fully disclose that information as required by federal law. The court papers also charge that Crawford assured federal ethics officers that he and his wife had sold stock in those companies, when they had not.
Crawford’s attorney, Barbara Van Gelder, said that under a plea agreement, her client would not dispute the government’s charges, and would likely face fines and a possible prison term of up to two years.
Click here to read the Department of Justice news release on the case’s outcome.
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