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Colorado Sen. to FDA: Regulatory science isn't enough

August 23, 2011 by MassDevice staff

The FDA's recent efforts to revamp the science behind developing and evaluating products are great, says Colo. Sen. Michael Bennet (D), but what is the agency doing to drive the global economy?

 

The FDA's newly minted plan to revamp its scientific methods isn't enough to ensure that the watchdog agency is doing its part in driving the global economy, according to junior Senator Michael Bennet (CO-D).

"I applaud the FDA's efforts to advance regulatory science through the recent release of the Agency's "Strategic Plan for Regulatory Science" but believe there is much more to be done," Bennet wrote in a recent letter to FDA head Dr. Margaret Hamburg.

The agency's strategic plan update its scientific foundations aimed to "foster innovation through better science," but Bennet urged the FDA to lay out a plan to ensure that the agency's review process is transparent and easy to navigate.

Specifically, Bennet asked the FDA to take steps to simplify its review process, incorporate modern tools, consider other countries' methods and incorporate public-private means to ease investment.

"At a time when our nation's drug, biotechnology, and medical device startup companies are struggling to access capital, we must strive to provide them with regulatory clarity and predictability in a way that is safe for patients but also meets their expectations regarding innovation," Bennet wrote in the letter. "It is time to take the next big step in that direction by mapping a clear path forward," Bennet.

The FDA's newest report focuses more on regulatory issues surrounding manufacturing and quality, outlining the agency's implementation strategy and expected public health impact.

Defined priority areas were:

·  Modernize toxicology to enhance product safety

·  Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes

·  Support new approaches to improve product manufacturing and quality

·  Ensure FDA readiness to evaluate innovative emerging technologies

·  Harness diverse data through information sciences to improve health outcomes

·  Implement a new prevention-focused food safety system to protect public health

·  Facilitate development of medical countermeasures to protect against threats to U.S. and global health and security

·  Strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products

"The breadth and scope of FDA's regulatory oversight is extraordinary, touching the lives of every American, through the food they eat, the medicines they take, and the medical devices they use," FDA Commissioner Dr. Margaret Hamburg said in prepared remarks. "As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard."

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