Quote:
Originally Posted by digger
FDA, Industry Reach Generic Drug Fee Agreement
The New York Times, Published August 16, 2011
U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals.
The Food and Drug Administration has been in negotiations with the generic drug industry since February to establish a user-fee program similar to one in place for brand-name drugs and medical devices.
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I first heard about the user-fee arrangement between Big Pharma and the FDA at the first International Parkinson's Congress in DC in 2006. The context was a panel discussion about the Parkinson's Pipeline in which our own Perry Cohen and Peggy Willocks were participants. The subject under discussion, as I recall, was the length of time required for trial drugs to pass through the process to final FDA approval. When I heard this arrangement described, it sounded so blatantly corrupt that I stood up and asked, "How long has this been going on?" It was then patiently explained to me by someone, maybe it was Perry, that the extra administrative load on the FDA created by the approval process required the hiring of additional personnel, and that the drug companies agreed to "help out" by paying a user fee to facilitate speeding up the flow through the pipeline. I was also assured that this practice had been going on for a number of years.
This arrangement probably makes perfectly good business sense, but the potential for serious conflict of interest seemed then, and still does to me, to be obvious.
Now we find that the generic drug manufacturers will be ponying up for the same scam, and the cost will, as with the brand name drugs, be passed on the patients.
What a world!
Robert