“FDA More Pro Industry Than Any Time in 35 Years”


So says Jim Dickinson, editor of FDAWebview, an industry newsletter that closely follows enforcement issues at the agency. After reviewing the deregulatory shifts at the Food and Drug Administration since the Carter administration, he writes:

It has taken almost a generation, but by now, the pro-industry infiltration of FDA’s culture is firmly entrenched. Not only is collaboration in product reviews officially encouraged, but good relationships across the regulatory fence hold the prospect of a possible future career in a well-paid industry job – a connection that is less likely to be publicly noticed in news media that now have to line up for information that has been filtered through agency press offices. The arm’s-length relationship that formerly ruled every contact between agency and industry has become a fading memory.

He says the shift in culture accelerated after the 1992 passage of the Prescription Drug User Fee Act, which made the agency dependent on industry funding. He concludes there’s nothing that Margaret Hamburg, the new commissioner, and Joshua Sharfstein, her deputy, can do about it. Quoting a former chief of enforcement, he writes:

User fees at FDA are the primary villain, because they “allowed the industry to dictate the changes at the FDA in programs, procedures and practices. It will be impossible for the Obama administration to reverse the trend because as long as the user fees are in place the industry has the upper hand.”

Radical stuff from an unexpected source.

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  1. FDA staff analysis
    There are specialists at the FDA who begin to analyze the data provided in the application nearly the instant it comes in the door.
    This is an in-depth analysis. FDA staffers go through the complete case histories of many – if not all – of the patients in each of the Phase I, II, and III clinical trials for the drug. At the end of the process, the FDA staffers assigned to the application create briefing documents. These documents cover every major part of the application. They advocate pro/con on the safety and efficacy of the product, the qualification of the manufacturing facility, and the content of the drug label. These briefing documents are then sent to FDA management.
    FDA management has the option of taking action on their own or forwarding the application and the briefing documents to an advisory committee of industry professionals.
    Creme always rises to the top!