Five Things Industry Can Do to Support True FDA Reform, and Restore Public Confidence Print E-mail
By Staff and Wire Reports   
Thursday, 13 October 2011 15:55
The FDA is one of the easiest punching bags in American politics. Depending on your point of view, it’s either too hard on business with its unreasonable demands, or too soft on those predatory drug companies seeking to profit off Grandma’s illness regardless of whether the products are safe.

 

When it does its job well, the FDA is like an umpire in baseball. Nobody notices. When it screws up, it’s screaming headline news. The polls show various scandals have taken a toll: About half of the U.S. public thinks the FDA is doing a bad job, and the perceptions are that drug companies put profits ahead of patients.

Not surprisingly, the FDA spends most of its time in a defensive crouch, fending off attacks from all angles, generally resisting most change. But last week it did an unusual thing, by sticking its neck out a couple inches. It suggested, in a 40-page strategic outline, a few ideas for how it can do a better job stimulating (not smothering) life sciences innovation in the U.S. It intends to do this while also ensuring the safety and effectiveness of new medical products.

FDA commissioner Margaret Hamburg has been feeling pressure behind the scenes from venture capitalists and their industry allies for the past 18 months or so. Sure enough, a day after she released the FDA report, the National Venture Capital Association released results of a survey that said the FDA—plagued by long delays, unpredictable decisions, poor communication, and excessive caution in new product reviews—has become the No. 1 reason why... (Continue reading this story at Xconomy)



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