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January 20, 2010

Is the FDA FUBAR*?
Journalist Merrill Goozner highlights some commentary from an FDA Insider who claims that the FDA is "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.

It's hard to talk about the creeping takeover of the federal government by corporate interests without sounds like a conspiracy-minded crackpot. And yet, when presented with evidence like this, what other conclusion can you draw? There's no question that the "collaboration" Dickinson refers to continues to this day -- and not just for drugs. It's an established fact that the FDA relied heavily on chemical industry lobbyists to draw up the (hopefully) now infamous 2008 FDA bisphenol-A report that declared the plastics ingredient totally safe, despite all evidence to the contrary. And with concerns over the budget deficit now front and center any attempt to eliminate what is a legitimate funding source (by that I mean those drug company fees) will likely fail. In a word: Ugh.

*Y'all know what FUBAR means, right?

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Anonymous Anonymous said...

A friend said that the changes began during the Reagen era. She had been visiting the FDA, researching on breastfeeding topics in the library. While walking the corridors she came across a name she knew on a door. She went in to say hello, and asked about some of the research the woman had published. All of the updated research on bottle feeding had been published, but not the beneficial findings of breastfeeding. She asked why. The FDA woman didn't know who she was, assuming she was one of them. The answer she gave was that if women in the USA went back to breastfeeding, US industry would lose it's cheap labour force - bottle feeding women can be easily separated from their babies.

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