How is the pharmaceutical industry making its inroads into the FDA?

The pharmaceutical industry's influence gets exerted in a number of ways. One, starting 10 years ago with the Prescription Drug User Fee Act (PDUFA), the influence was exerted by their directly funding, paying cash right up front, for FDA review. So in many ways, the FDA started looking upon the industry as their client, instead of the public and the public health, which should be the client.

A second way in which the industry influence occurs is by having leaders in the drug division who are spineless and gutless, and who don't like controversy. I have heard over and over again, directly from these people, "Why can't this be settled on a scientific and medical basis?" They don't like to take on the very awesome forces of the drug industry and a lot of its indentured servants, so to speak, in academic medicine.

So the attitude by the leaders there is, "avoid conflict" -- and avoiding conflict means doing what the industry wants. A third way in ... more.

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