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Former FDA head says biotech business model ‘is basically falling apart’

 BioFlash Editor-Boston Business Journal

A former head of the U.S. Food and Drug Administration who will help lead a discussion at Tufts University today says that the agency is holding back, rather than encouraging, the creation of groundbreaking new drugs.

Andrew von Eschenbach, commissioner of the FDA for more than two years until January 2009, said in an interview Friday that as a result of FDA demands, drug trials have become too large and expensive. He said the FDA has become too “risk-averse” at a time when scientists in the pharmaceutical industry are moving forward like never before.

“The business model is basically falling apart at a time when the scientific possibilities are unbelievable,” he said.

Von Eschenbach now leads the effort to reform the FDA at the Manhattan Institute, a New York-based public policy group that runs Project FDA. The group is co-hosting a symposium today at the Tufts Center for the Study of Drug Development that will involve biotech leaders, congressmen and policy experts to discuss the 21st Century Cures Initiative, an effort by the House Energy and Commerce Committee to speed up the innovation and commercialization of new treatments.

Von Eschenbach said that while the initiative is looking at tax policies and ways to fund research into new drugs, “one of the areas that’s crucial to accelerate R&D is regulatory policy.”

He said the FDA needs to allow for more drugs to be approved conditionally based on evidence from measurable substances in the body that show they work, called biomarkers. He also said the agency needs to do a better job laying out the approval process for new products that combine drugs with medical devices or diagnostic tests.

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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