Title: White House wants to control the FDA
Post by floridian on Jan 14th, 2004, 4:25pm
This could impair the FDA's ability to warn the public about newly discovered side effects of medicines.
Quote: WASHINGTON - Under a new proposal, the White House would decide what and when the public would be told about an outbreak of mad cow disease, an anthrax release, a nuclear plant accident or any other crisis.
The White House Office of Management and Budget is trying to gain final control over release of emergency declarations from the federal agencies responsible for public health, safety and the environment.
The OMB also wants to manage scientific and technical evaluations - known as peer reviews - of all major government rules, plans, proposed regulations and pronouncements. ...
"Speaker after speaker warned that implementation of this proposal would lead to increased costs and delays in disseminating information to the public and in promulgating health, safety, environmental and other regulations, while potentially damaging the existing system of peer review," the letter said. ...
They offered examples of recent events from one agency - the Food and Drug Administration - where a delay caused by the OMB could have been dangerous. Among them:
An emergency termination of a clinical trial of anti-arrhythmic drugs "that was not beneficial, but in fact dangerous."
An announcement that hormone replacement therapy for post-menopausal women was causing adverse effects.
Last October's halting of a clinical trial of a cancer drug to reduce the rate of breast cancer recurrence.
"We see no public benefit from mandating an additional layer of OMB interposition, peer review and public comments that, at best, would have delayed these announcements for untold months," said the comments from the groups, which represent more than 100 medical and scientific societies.
Michael Taylor, former deputy commissioner at the FDA under the first Bush administration, warned that the OMB's involvement in the dissemination of information on "imminent health hazards" is dangerous.
Taylor cited the severe November hepatitis outbreak from contaminated green onions at a Mexican fast food restaurant near Pittsburgh.
http://www.stltoday.com/stltoday/news/stories.nsf/News/189564E117AF585586256E17007E600A?OpenDocument&Headline=White+House+seeks+control+on+health,+safety
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Why replace the judgement of scientists with the judgement of bean counters and politicians??
(sarcasm deleted) |