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Paul Kiesel
Paul Kiesel
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Henry Waxman vs the FDA?

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Will incoming House Energy and Commerce Committee chairman Henry Waxman take on the FDA like his predecessor, John Dingell?

Rep. Dingell (D-Mich), unfortunately, was very conservative when it came to energy and auto emissions (and it’s likely that’s one of a handful of reasons why Waxman was able to take Dingell’s chair), but, fortunately, he had been a big supporter for change at the FDA and the industries it regulates.

The House Energy and Commerce Committee has currently more than a dozen ongoing investigations of issues drug, food and FDA-related issues that have made their targets sweat, according to The Wall Street Journal. In May, a hearing went so poorly for Merck, Schering-Plough and Pfizer that PhRMA’s chief Billy Tauzin warned his members to volunteer DTC restrictions or they’d have to face the hand Dingell and his committee deal them.

The HEC committee pointed to, in that May hearing, a number of bad decisions that were made at the FDA involving food and drug safety, and, as well, the committee put FDA executives under a microscope, lambasting their ill-advised handling and regulation of medical devices, such as the wide-spread problems with contaminated heparin from 2007 and early 2008.

FDA executives may feel they can breath a sigh of relief now that Dingell isn’t barking them up a tree, however, they need to first wisely look at two recurring factors:

1. Bart Stupak, the tough-as-nails chair of the Investigations Subcommittee, formerly under Dingell and now Waxman, will stay in that positions, meaning those investigations that were taking place last spring will continue and, if the FDA doesn’t get its act together in regards to tougher regulation, accelerate;

2. "Waxman is in the middle of pending legislation that would allow lawsuits against medical device makers, which would undo this year’s Supreme Court preemption decision affecting them," (online.wsj.com, 11/20/2008).

Therefore, the FDA can and should work to strengthen its ability to regulate the industries it oversees, and the agency should do what it can to work with Waxman to help keep Americans safer.