Healthy Skepticism Library item: 5265

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Harris G.
Top Democrat Finds F.D.A.'s Efforts Have Plunged
New York Times 2006 Jun 27
http://www.nytimes.com/2006/06/27/health/policy/27fda.html?_r=1&th=&oref=slogin&emc=th&pagewanted=print

Notes:

Ralph Faggotter’s comments:

The health authorities of most countries look to the FDA to take the lead in determining which medicines are safe and effective, and for what conditions it is reasonable to prescribe them, and with what provisos.

By lowering their standards, the FDA is doing the entire world a disservice.

Full text:

June 27, 2006
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.”

David 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.

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.

Several former top officials of the agency attributed the decline in
enforcement actions to budget problems.

“This is a tragedy,” said Peter 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.”