Originally published October 28 2005
Former FDA commissioner blasts the agency for its poor reputation
by Mike Adams, the Health Ranger, NaturalNews Editor
David Kessler, former FDA commissioner during the Clinton and Bush administrations, spoke harshly on National Public Radio about the agency's current policies and behavior.
The FDA's failure to ensure drugs are properly tested in trials designed to detect serious adverse effects, and the agency's failure to require follow-up post-marketing studies to be reasonably secure in the knowledge that no lethal drugs are unleashed on the public has eroded public trust.
Former FDA Commissioner, Dr. David Kessler (who served under both former President George Bush and Bill Clinton) and is now dean of the University of California at San Francisco, told National Public Radio (on All Things Considered, October 12) that the FDA's credibility is at the lowest level he has ever seen.
A new study to be released on October 18 recommends increasing pharmaceutical user fees specifically to assess the safety of newly marketed drugs: "There is a real, dire need for randomized, clinical trials comparing the safety of drugs for chronic conditions," said Daniel Carpenter, MD, professor and director of graduate studies in Harvard�s Department of Government.
Instead of addressing life-threatening drug safety issues, the FDA has taken steps to protect corporate drug giants.
The FDA has, once again, come to the defense of Pfizer Pharmaceuticals--a clear demonstration of the agency continued disregard for public safety.
The FDA argued that a manufacturer's failure to warn about hazardous, potentially lethal drug effects, is absolved from legal liability if the FDA had not required such warnings.
In the Amicus brief, the FDA counsel SPECULATES that IF Pfizer would have proposed adding a warning (before 2004) about an increased risk for suicide-related behavior in children and adolescents prescribed Zoloft, the FDA would have prevented the company from doing so, arguing--irrationally--that to warn about a safety hazard is to "misbrand" the drug.
Second, FDA's argument is illegitimate because it cannot provide evidence of Pfizer having, in fact, submitted such a request for a change of label.
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