FDA chief urges ‘new era of partnership’

By Robert Weisman

 | Globe Staff   April 05, 2014CAMBRIDGE — The head of the US agency that approves medicines Friday called for more regulatory flexibility and “a new era of partnership” with the biopharmaceutical industry in bringing new treatments to patients.
“We see this model emerging where we don’t just wait for an application to come to us,” Food and Drug Administration commissioner Margaret Hamburg told more than 300 drug-making executives at the annual meeting of the Massachusetts Biotechnology Council trade group. “We engage with you early and work with you throughout the development process.”

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Hamburg said the partnership promised “swifter, more efficient product development and product review” after years of criticism from the industry that the drug approval process was too long and cumbersome. FDA officials last year added a “breakthrough therapy” designation to its arsenal of programs meant to accelerate the review of drugs that address pressing unmet medical needs and improve the communications between drug companies and regulators.

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