(September 9, 2011) The United States Food and Drug Administration (FDA), once the world's "gold standard" for food, drug, and device regulation, has evolved from industry regulator to industry captive.
Political scientists are not surprised. The evolution from tough regulator to passive regulator to industry captive is a pattern in Washington. Unless an agency engages in a major system of reinvigoration, the spiral continues. But the FDA seems comfortable being the hand-maiden for industry; it has brought big bucks to the agency and lucrative jobs after time at the FDA.
The big bucks are in the FDA's pay-to-play approval system. Drug companies pay seven-figure amounts into FDA coffers to gain approval of their drugs.
FDA staff knows that the cash means higher salaries and more perks in the agency budget. The drug companies know the high fees prevent small competitors with good ideas from getting their products to market.
The coziness between the FDA and major drug and device companies gets tighter, while innovative entrepreneurs are shut out and the public loses twice: good drugs aren't being considered, and controversial drugs are rubber-stamped.