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

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

Eschenbach 2Former FDA head says biotech business model ‘is basically falling apart’ (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.

The rise of so-called “precision medicine” is increasing creating drugs that are aimed at smaller and smaller subsets of patients, and the agency needs to develop ways to arrive at “a level of comfort and confidence” in them more quickly, he said.

“You want to get the right drugs to the right patients at the right time,” he said. “We have the tools to do that, but we need to regulatory environment to allow it.”

He said the information gathered from a series of meetings – of which today’s at Tufts is the first – will be used to “inform members of Congress” as to how to bring about changes at the FDA. Other participants at today’s meeting will be Nick Leschly, president and CEO of bluebird bio; Alan Eisenberg, vice president, federal government relations for Celgene; and Robert Popovian, senior director, advocacy and professional relations at Pfizer.

“We don’t want rash decisions (on new drugs),” von Eschenbach said. “(But) the culture and climate at the (FDA) has become more and more risk-averse.”

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