Who will watch the watchdogs? (part 3)

Doesn't this really seem whacky to you?

The New York Times reports that Congress has failed to provide the funding that the Food and Drug Administration (FDA) needs to fully and promptly investigate and approve new drugs and medical devices as part of its regulatory responsibility.

Soooo, the companies that make drugs and medical devices volunteered to pay "user fees" to the FDA to help pay for more FDA staff and scientists who would do the testing, evaluation and regulatory approval of new drugs and medical devices. The stated aim of the big drug and device manufacturers was to "speed up" the regulatory review process.

These corporate user fees now pay for 60% of the cost of reviewing and approving new drugs, and about 20% of the cost of reviewing and approving new medical devices.

Almost half of the FDA scientists have publicly said they think these user fees are buying influence in the regulatory process.

Does anyone with clout in the FDA think there is anything wrong about this arrangement?



We could naively hope the FDA scientists are wrong…..

We can also hope that the prescriptions ordered by our doctors aren't for drugs that went through an inadequate, "speeded up" regulatory review…

Quis custodiet ipsos custodes?