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Author: Guest Contributor

Date: November 14th, 2011

Last month, the FDA published a long awaited report on biomedical innovation, their only course of defense in the recent onslaught against the agency. Historically, the FDA has played a significant role in the protection of our health, assuming sole responsibility for the approval of medical products, but it appears that congressional confidence in the agency is waning.

The FDA fell under fire during a House Republican Forum on Jobs and Innovation in late September, a forum communicated through a series of aggressive tweets from @HouseCommerce.

“#FDA 's #reg delays harmful #4jobs, #4patients, & to #MedInnovation by hindering future investment in #MedTech. #2futures 1.usa.gov/psYYnf”

“#MedTech companies report European #regulatory authorities more predictable & transparent than #FDA. #MedInnovation bit.ly/qcXTRo“

Leaders of the medical device industry openly criticized the FDA review process for devices; claiming the agency’s practices are ineffective and hindering innovation, and becoming incentive for them to move operations abroad. Forum attendees blame the stagnation of medical product development on FDA delays, an issue potentially attributable to the agency’s limited resources. Despite this, Congress awarded medical product review centers within the FDA with none of the funding hikes proposed by President Obama for FY 2012. While the Senate approved a $50 million boost in the FDA’s budget, the funding will be exclusive to the implementation of a food safety initiative.

In their report on biomedical innovation, the FDA outlines a ‘blue print’ to spur biomedical innovation, promising to standardize the review process and streamline regulations, a report publicly endorsed by PhRMA. The FDA appears confident that internal restructure will meet the demands of industry. Dr. Elizabeth Mansfield of CDHR defensively touted during a briefing last week, “We [FDA] aren’t dumb.” in response to questions of how the FDA will accommodate emerging technologies like personalized medicine. While the report promises the FDA’s intent to harbor, not hinder, medical innovation, industry will want to see improvements in the process before FDA can leave the hot seat.

FDA Report on Innovation

PhRMA Press Release

Key Points of PDUFA V Reauthorization Technical Letter

--Steffanie Bezruki, University of Illinois at Urbana-Champaign, Class of 2012. Contact her at [email protected]






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