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Trade Groups Gain Feds' Ear

Trade Groups Gain Feds' Ear [Boston Herald]

From Boston Herald (MA) (July 11, 2011)

July 10--CEOs of Massachusetts biotech and medical device companies who have had issues with new federal policies will gain direct access to the commissioner of their chief regulatory agency today.

U.S. Sen. John Kerry (D-Mass.) will accompany Food and Drug Administration Commissioner Dr. Margaret Hamburg to two roundtables in Boston.

"Massachusetts isn't just the industry leader in medical devices and biotech, but the policy leader as well," Kerry said in a statement. "There are a host of issues before the FDA that our industry leaders are watching closely, because they directly affect their ability to create jobs, spur innovation and help patients."

Kerry and Hamburg first will meet with 50 CEOs and senior managers from companies that are members of the Massachusetts Medical Device Industry Council. Their discussion will center on future changes to the 510(k) medical device clearance process, the upcoming reauthorization of the Medical Device User Fee Act and building a more productive relationship between the industry and the FDA's Center for Devices and Radiological Health.

Kerry's Hub invitation to Hamburg follows a series of conference calls and meetings that he had with biotech and medical device leaders in the last several months, according to his office.

Kerry's Republican counterpart, U.S. Sen. Scott Brown, harshly criticized the FDA last month in a Hub speech, saying it is "throwing a wet blanket" over innovation in the biotech and medical device industries.

This afternoon, Kerry and Hamburg will meet with executives from Massachusetts Biotechnology Council companies for a roundtable talk about best practices for drug development, biosimilars (follow-ons to biotech drugs), personalized medicine and spurring innovation.

In a statement, MassBio CEO Robert Coughlin thanked Kerry for bringing biotech leaders together with Hamburg to discuss "how we can continue to thrive and improve lives."

"The FDA has long played a vital role in the research, development and commercialization of the life-changing therapies and technologies that Massachusetts life sciences companies work on every day to improve the lives of patients around the world," Coughlin said.


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Posted: July 2011