NYT April 16 2008
Panel's Bipartisan View: F.D.A. Is Underfunded
A recent Senate Resolution increasing the FDA's $1.8 Billion budget by another $375 Million from Govt. revenues speaks of "User Fees" paid in to the FDA from drug and medical device manufacturers. Note the word "User" as in drug and device manufacturers "Using" the FDA. What are they "Using" it for?
FDA Commissioner Dr. von Eschenbach seemed hesitant to accept this $375 Million. Does a Govt. Agency turning Down another $375 Million strike anyone else as low budget sci-fi? Claims were advanced last month from outside the agency that without additional funds American lives were at risk, and Dr. von Eschenbach warned that "peril exists."
In a later speech, Dr. von Eschenbach about faced with the pronouncement that the FDA has been "eminently successful up to this period of time", and that it remains "the world's gold standard."
The FDA has been eminently successful, at approving atypical antipsychotics for children for "irritability": atypical antipsychotics which shorten people's lives by decades.
It occurs to us that if those drug and device co. "User" fees were taken out of FDA hands [the very hands regulating those same "User" fee paying drug and device cos.] that those FDA hands could do their job just fine, Without having to be called onto the carpet in the US House of Representatives to explain themselves.
$1.8 Billion is one heck of a pile of everybody else's money, in exchange for an FDA that tells Congress that from their own "eminently successful world's gold standard, peril exists."
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