Wednesday, October 07, 2009
Fallout from NJ Democrat meddling at the FDA will hold up medical device approval. Thank you very much New Jersey!
Thanks to the intervention of 4 New Jersey Democrats in the FDA approval process for one of their constituents, all medical devices are on the sloooooow track for approval. An editorial in the New York Times summarizes this nicely here.
In short: A New Jersey orthopedic medical device firm, ReGen turned to four Democrats to lobby on their behalf for approval of an orthopedic knee device — Sen Robert Menendez and Sen. Frank Lautenberg, as well as Congressmen Frank Pallone and Steven Rothman. According to the Washington Post, Regen paid Sen Mendez's former chief of staff nearly $300,000 for lobbying services, and Hutton contributed nearly $40,000 to Menendez and the three other Democrats who wrote a letter to the FDA urging the agency to make a decision on the company’s application.
This kind of "pay for play" is par for the course for New Jersey Democrats, but not as appreciated by federal regulators. The blowback from the intervention of theses pols and former FDA head, Andrew von Eschenbach, has reignited scrutiny of the FDA's practices and procedures.
Caught up in this are hundreds of devices in final stages of approval, including the next generations of silicone (and saline) breast implants. I wrote about this last April in a post called "An Exercise in Clock Watching" talking about the bureaucracy of FDA device approval in re. to breast implants. It's amazing and frustrating to think that improved devices used world-wide (US excepted) for 15+ years are still clinically unavailable here.