Reply #15: My mistake. But here's the paragraph in DVM mag [View All]

[CAcyclist]

I thought his pharmacy degree was a veterinary pharmacy degree, not a regular one, so I am mistaken about that. I still think he's a political hack. The below paragraph illustrates to me that the FDA is too involved with industry helping them get drugs ready for approval . That shouldn't be the focus of the FDA - it clearly creates a conflict of interest.

http://dvm.adv100.com/dvm/article/articleDetail.jsp?id=144595

User fees
There was a time in the 1980s, Crawford recalls, that saw far fewer products making their way through FDA to market.

"One year, we saw no new veterinary and only four human new molecular entities. If there was a person with a rare disease that could later be treated with some pharmaceutical or an animal population that need special therapy, they could forget it in the United States. It was a period of time that FDA was very conservative and afraid of being too cozy with the industry."

In 1993, human medicine adopted user fees as a mechanism to spur drug approvals. Congress has approved similar legislation for FDA's Center for Veterinary Medicine, dubbed the Animal Drug User Fee Act (ADUFA), which ultimately will allow CVM to hire 60 new people to review drugs.

Crawford says he originally was opposed to user fees because he thought they might be a conflict of interest, but he's a believer now. The concept gets money into FDA for specific review.

He says it also allows the agency to prepare for new chemicals coming through the research and development pipeline.

"We used to hear things about a new generation of antibiotics coming. But we didn't dare ask industry because that would be a conflict of interest. So we hung around here with the same old tired collection of personnel; there are too few of us and (we're) too inexperienced. And then along came this whole new set of drugs that we were not ready for, nor did we have expertise in. Now we sort of know what is coming, and we can plan for it. I think ADUFA and its descendants have been very good for FDA and good for the country."