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Posted by on Dec 10, 2008 in Cardiology, FDA, Pharma

Nissen Maneuvers for FDA Commish?

Nissen Maneuvers for FDA Commish?

Steven_Nissen_thumb.jpg

Like a true politician, cardiologist Steven Nissen appears to talk out of both sides of his mouth.

The Cleveland Clinic doctor recently criticized the FDA for not adhering to the Pharmaceutical Drug User Fee Act (PDUFA), which allows the agency to collect fees from drug companies to support the timely review of new drug applications, reported yesterday’s “Pink Sheet.”  According to the publication, Nissen publicly chastised the FDA for missing PDUFA deadlines for at least 15 drugs, some of which “could be considered major innovations.”

As a remedy, Nissen suggested “limited-term approval” of drugs, with the stipulation that large postmarketing studies would be conducted (which isn’t so different from what occurs now). He also supported pharma’s use of simpler clinical trials, which may provide less information, to lower drug-development costs.

This from a man who is best known for his criticism of Avandia (rosiglitazone; GSK) and Vioxx (Merck), both of which were linked to increased risks of cardiovascular side effects in Nissen’s post-approval meta-analyses (see here and here). As a consequence, Vioxx was famously pulled from the market by Merck in 2004, the Avandia label received a black-box warning, and both drugs have been the focus of a considerable number of safety-oriented lawsuits. The FDA has been criticized at length for its hasty approval of these drugs. 

The “Pink Sheet” suggests that Nissen’s latest push to speed up the drug-approval process is an attempt to curry favor with industry in a thinly veiled bid for FDA commissioner. The doctor’s on the short list of candidates, as least as far as the press is concerned; although Nissen has declined to comment publicly about the position.

HT: Pharmalot

2006 photo of Steven Nissen testifying at the Hearing on Building a 21st Century FDA.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.