Connecticut Commentary: Red Notes from a Blue State

The FDA’s philosophy seems to be that the way to protect the public from uncertainty about the safety of new drugs is to stop approving any at all. But who will protect the public from the FDA -- Henry I Miller, M.D. These past several months, the Food and Drug Administration has been under severe attack by former officials, by unfairly treated pharmaceutical companies, and by patients in pain. Let us list a sampling. Avastin, a breast-cancer drug, is delayed a year or more because FDA wants additional data. Moving the goalpost in the middle of the game is vexing for drug-developers, says Henry I. Miller, M.D., FDA official 1979-94. The FDA some times requires testing long after it has approved the therapy. FDA approved doxepin for depression in 1969. Doxepin may be useful as a sleeping pill at very low dosage. FDA has ordered animal testing, a procedure always done prior to use on humans. Vioxx, an arthritis drug for pain was withdrawn by Merck, its maker, when it was found to...