Monday, June 30, 2008

Drug Companies Lament Stricter FDA Scrutiny

An article in this morning's Wall Street Journal by Avery Johnson and Ron Winslow details the flip-side of increased FDA scrutiny: fewer new drugs in the pipeline. Drug companies such as Eli Lilly & Co, Japan's Daiichi Sankyo Co. and Merck believe that the FDA has become too careful while consumer advocates welcome the FDA's increased warnings and drug withdrawals. Here's an excerpt of the article:

Grousing by drug-industry executives about the FDA is nothing new. It's a product of the perennial tension between regulators and the companies they oversee.

But the Vioxx debacle, which sparked harsh criticism of both drug companies and their chief regulator, appears to have led to a climate shift. The drug industry largely has itself to blame for allegedly manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, which created widespread mistrust. The FDA, for its part, was harshly criticized for its decisions on Vioxx and in a litany of subsequent drug scares.

Outspoken scientists, watchdog groups, medical-journal editors and politicians have fanned worries about safety. The wave of post-Vioxx drug scares included concerns that GlaxoSmithKline PLC's widely used diabetes drug, Avandia, could raise heart-attack risk, and that Pfizer Inc.'s smoking-cessation drug, Chantix, may be connected to suicides. More than 80 U.S. deaths linked to contaminated heparin from China have further ratcheted up public anxiety. The FDA has been battered by criticism that it wasn't vigilant enough, including from Cleveland Clinic cardiologist Steven Nissen, Sen. Chuck Grassley of Iowa and Rep. John Dingell of Michigan.


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