Weak Aftermarket Review Effort at FDA

A recent New York Times article that draws attention to the fact that up until 2002, it was a common practice for the pharmaceutical industry to ply physicians with free dinners, tickets or other high priced swag-- and that FDA Officers allegedly have proof that this practice has not stopped, but continues unabated.

That's really bad, but hardly unexpected. Expect corporations to behave poorly. It's not like the government was working in conjunction with drug companies to approve unsafe drugs.

Ahem.

There is a much more interesting factoid further down in the article. It seems the FDA has 1000 staff members working to approve new drugs but only around 100 working on making sure existing drugs are safe.

Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington, told the panel that the agency had become too focused on approving new drugs at the expense of making sure that approved ones were safe. This could make the upcoming Vioxx class action much more interesting.

"In the office of new drugs, more than 1,000 employees work to review a few dozen new drugs per year," Dr. Psaty said. "In the office of drug safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market."

He described the agency's structure as "just what the drug industry desires: a powerful engine to approve new drugs and a weak effort to investigate safety in a postmarketing center."

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