Nissen takes a stand with the FDA

Steve Nissen (photo) knows how to attract attention. Most recently, he criticized the FDA regarding the Pharmaceutical Drug User Fee Act (PDUFA), which he isn't too fond of in the first place.

Nissen says FDA misses drug approval deadlines frequently when it accepts industry fees to review drugs more expediently.  "If you take the money, and you agree to perform based upon the money, you've got to perform," he said at a conference. He emphasized the point by saying that the agency did not make the deadline for at least 15 drugs in 2008.

Some see the public commentary as a possible ploy to show some empathy to big pharma in light of the opening at the FDA for a new commissioner. For its part, FDA claimed the slips were a result of diminished resources and a shift toward implementing newer safety legislation. Nissen did acknowledge the agency was short on resources, particularly when it comes to technology. 

Many consider the cardiologist as an industry watchdog, yet regard him as a top contender to fill Andy von Eschenbach's commissioner shoes at the FDA.

- see the Pharmalot blog entry 

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Pharma's love/hate relationship with Dr. Nissen (July 2007)