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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by honeybee on June 27, 2006, at 10:04:18
From the NYTimes:
Top Democrat Finds F.D.A.'s Efforts Have Plunged
By GARDINER HARRISWASHINGTON, 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."
Posted by zeugma on June 27, 2006, at 12:05:23
In reply to The Embattled (or Dismantled) FDA, posted by honeybee on June 27, 2006, at 10:04:18
The Bush Administration has dismantled the FDA.
Yet, on this site, they are beyond reproach, by administrative fiat. I am experiencing some cognitive dissonance as a result.
-z
Posted by Dr. Bob on June 28, 2006, at 0:19:56
In reply to Re: The Embattled (or Dismantled) FDA » honeybee, posted by zeugma on June 27, 2006, at 12:05:23
> The Bush Administration has dismantled the FDA.
Please be sensitive to the feelings of others (such as supporters of the Bush Administration).
But please don't take this personally, this doesn't mean I don't like you or think you're a bad person.
> Yet, on this site, they are beyond reproach, by administrative fiat. I am experiencing some cognitive dissonance as a result.
I'm sorry about your experience, but the goal of this site is support, not reproach.
If you or others have questions about this or about posting policies in general, or are interested in alternative ways of expressing yourself, please first see the FAQ:
http://www.dr-bob.org/babble/faq.html#civil
http://www.dr-bob.org/babble/faq.html#enforceYou might want to consider asking another poster to be your "civility buddy" and to preview your posts before you submit them.
Follow-ups regarding these issues should be redirected to Psycho-Babble Administration. They, as well as replies to the above post, should of course themselves be civil.
Thanks,
Bob
PS: I'm trying out a new system:
previous block: 4 weeks
period of time since previous block: 7 weeks
uncivil toward a particular individual or group: yes
particularly uncivil: no
different type of incivility: no
clearly didn't understand PBC and made effort to reply: no
provoked: no
uncivil in multiple posts at same time: no
already archived: noIf we take 7 weeks, divide by 10, and round down, that's a reduction of 0 weeks. If we apply that to your previous block, that's 4 - 0 = 4 weeks. And if we triple that, that's 12 weeks.
Posted by teejay on June 29, 2006, at 21:14:38
In reply to Re: blocked for 12 weeks » zeugma, posted by Dr. Bob on June 28, 2006, at 0:19:56
I'm sorry about your experience, but the goal of this site is support, not reproach.
Yes but only the support of people who support Bush it seems.
Posted by Dr. Bob on July 2, 2006, at 4:13:56
In reply to Re: blocked for 12 weeks, posted by teejay on June 29, 2006, at 21:14:38
> > I'm sorry about your experience, but the goal of this site is support, not reproach.
>
> Yes but only the support of people who support Bush it seems.Not just Bush. Have you tried to support someone else?
Bob
This is the end of the thread.
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