FDA "Has Harmed Public Health"

Under David Kessler, the US Food and Drug Administration wielded itspower in making decisions that harmed rather than helped the public health, claims a study from the Institute for Policy Innovation.

For example, says the study, prescribing drugs for off-label uses is perfectly legal and widely accepted, yet the FDA banned companies from sharing the finding that aspirin can prevent heart attacks because it had not approved aspirin for this off-label use. "Never mind the fact that sound science" had made this discovery, it says, "the FDA wanted to be the decision maker, and made off-label uses more dangerous by squelching even information about safe dosage levels."

Citing other examples in the silicone breast implant and home HIV test area, study author Robert Goldberg concludes: "it would be a mistake to assume that it would be possible to reinvent the FDA by appointing a new commissioner. Kessler's use of power set a standard and transformed the way the FDA operates."