Gunning for FDA Changes

FDA Leader Criticized

We wrote the "State of the FDA" about a couple of reports documenting FDA management shortcomings compounded by budget shortfalls that compromise the health and safety of US citizens. Now Rep. Bart Stupak (D-MI), who heads the Subcommittee on Oversight and Investigations in the House Energy and Commerce Committee has called for FDA commissioner Andrew von Eschenbach to be replaced. Eschenbach has been in the post a little over a year.

In a press release Feb. 1, 2008 on the FDA, Stupak said the agency was no longer a "pending" crisis, but rife with problems and fresh off a formidable record of "378 recalls last year on everything from peanut butter to pet food to drugs". Stupak's goal "is to help identify what went wrong and implement changes to minimize negative health effects on the American people." Stupak even has a replacement candidate in mind according to the Wall Street Journal.

Firecracker Appointees

However some politicians see the Michigan Democrat as a little too aggressive. Rep. Joe Barton (R-TX) says that firing the commissioner is a bad idea and told the journal that Dr. von Eschenbach is a "dedicated public servant," who has "certainly not done anything unethical or illegal". (Gold Star commendable these days, but shouldn't we be throttling for a higher standard?)

Some news agencies scurvily suggest that the death of Stupak's son from suicide, a reaction to the acne drug Accutane, motivates his attention to the FDA's problems. However the congressman points out that while the incident gave him insight into the FDA, if people knew how little oversight the agency had on some products they'd be "marching in the streets." (like the Sixties?)

It's too bad Stupak wasn't in on the Senate confirmation hearings in August, 2006, since perhaps he could have guided the leadership choice at the beginning of the process. The Senate deliberated during von Eschenbach's confirmation hearings, voicing reservations about his suspected attention to politics over science. The commissioner is a family friend of President Bush's who had what Newsweek at the time called "a history of generating controversy".

Prior to his FDA tenure he worked at the National Cancer Institute (NCI), where he "introduced prayer to commission meetings", unrealistically set a goal of eliminating death from cancer by 2015, and was called a "disaster" by some staffers. Senators Murray and Clinton balked on his confirmation over the stance the FDA was taking on Plan B, the birth control pill. In what seemed like a sort of a quid pro quo deal, once Plan B got passed von Eschenbach got confirmed.

The interesting thing about Bush's political appointees to science agencies is that the lifecycles between Senate confirmation and given appointees' agencies' disasters has become quite short, in a way that nicely matches the current pace of news. The predictability and familiarity of it all gives us a sense of reassurance in a day when little else is predictable. Reporters aren't like - von Eschenbach who? It's just - oh yeah, that guy everyone worried about a year and a half ago.

But again, as with many of the science agencies it's not all about the commissioner. Stupak acknowledges that the FDA has entrenched problems that preceded Eschenbach's short tenure.

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Acronym Required wrote about von Eschenbach's confirmation hearings in "The FDA'S 'Medical Ideology'"

We wrote "Resuscitating The FDA", about the FDA in the wake of various fiascoes.

"FDA -- Calling Off The Dogs", is about Plan B and FDA staff turnover.

"Ethics- The NIH and FDA", discusses conflicts of interests among scientists in these two agencies.

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