Tuesday, June 27, 2006

Food and Drug Administration: The Agency Industry Is Paying To Get

Well this is certainly a shocker:
A 15-month inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration.

For instance, the investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000.

The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Representative Henry A. Waxman of California, the senior Democrat on the House Government Reform Committee.
And the decline in enforcement is not a result of does not a result of goo behavior:
The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the F.D.A. continued to uncover about the same number of problems at drug and device companies as before, Mr. Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations.
But on't worry, say industry representatives, these are only paperwork violations.

In one prominent case, in December 2000, a worker at a nursing home in Xenia, Ohio, mistakenly hooked up a tank of nitrogen gas to the home's oxygen delivery system. Four residents died.

In the months that followed, investigators for the agency concluded that the company that delivered the tanks, BOC Gases, was partly to blame for the mix-up, given what they deemed inadequacy of the company's own controls and employee training. Indeed, BOC had a "corporate-wide problem," F.D.A. documents at the time said. The investigators recommended prosecution, but the agency took no enforcement action.

Kristina Schurr, a spokeswoman for BOC, said that the company's controls had not been to blame but that in any case it had improved its procedures since then.
We're innocent and we promise not to do it again.

Aside from this administration's well-known closeness with the industries it's supposed to be regulating, there may be another cause of this problem:
Dr. Sidney M. Wolfe, director of the Health Research Group at the watchdog organization Public Citizen, noted that the agency now received about $380 million a year in fees from drug makers.

"The public," Dr. Wolfe said, "is getting the kind of F.D.A. that the industry is paying for them to get."
Full report here.