FDA Enforcement of Health Issues Has Dropped Sharply in First Five Years of Bush Administration

[Guest guest]

I just found this on the New York Times website.I think the situation

with the EPA, CDC, etc. is similar.

Under BushCo, Federal agencies are increasingly are doing whatever the

GOP's corporate masters want them to do, which is often basically

nothing.

http://www.nytimes.com/2006/06/27/health/policy/27fda.html

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Top Democrat Finds F.D.A.'s Efforts Have Plunged

By GARDINER HARRIS

WASHINGTON, June 26 — 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.

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.

The biggest decline in enforcement actions was found at the agency's

device center, where they decreased 65 percent in the five-year period

despite a wave of problems with devices including implantable

defibrillators and pacemakers.

" Americans have relied on F.D.A. to ensure the safety of their food

and drugs for 100 years, " Mr. Waxman said. " But under the Bush

administration, enforcement efforts have plummeted and serious

violations are ignored. "

K. Elder, the director of the agency's Office of Enforcement,

explained that the F.D.A. had increasingly focused on the most serious

violations.

" As a result of F.D.A.'s focus on those firms and those violations

that present the highest risk to consumers and public health, " Mr.

Elder said in a statement, " the agency has taken prompt, targeted and

aggressive action against firms that are in violation of law. "

Jack Calfee, a resident scholar at the conservative American

Enterprise Institute, said the decline in the statistics was

meaningless because most of the violations involved paperwork

problems.

" I doubt that it makes a significant difference in the safety of drugs

or other products, " Mr. Calfee said.

Mr. Waxman began his inquiry after Congressional hearings in 2004

suggested that the agency was partly to blame for a shortage of flu

vaccines. His staff requested thousands of documents from the F.D.A.

The investigation found that by almost every measure, enforcement

actions had significantly declined from 2000 to 2005. The lone

exception was in the number of products that had to be recalled from

the market: that increased 44 percent.

" Since one of the goals of an enforcement system is to deter

violations and keep dangerous products off of the market, " the report

said, " the increase in recalls is not a hallmark of effective

enforcement. "

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.

a 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.

Several former top officials of the agency attributed the decline in

enforcement actions to budget problems.

" This is a tragedy, " said Barton Hutt, a former general counsel

of the F.D.A. who now represents drug companies and teaches food and

drug law at Harvard. " Congress has failed to realize that our single

most important government agency is being systematically dismantled. "

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. "