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Obama Signs FDA User Fees, Modernization Bill into Law

NEW YORK (GenomeWeb News) – US President Barack Obama yesterday signed a bill into law that will expand the amount of user fees that the Food and Drug Administration collects from industry in the coming years, enact measures to shore up the agency's review resources, and streamline and speed up some of its regulatory processes.

The Food and Drug Safety and Innovation Act will enable FDA to raise $6 billion in user fees over the next five years, including $595 million from medical device companies under the Medical Device User Fee Act (MDUFA), compared with $287 million over the past five years.

"This legislation, which passed both the House and Senate with overwhelming bipartisan majorities, will help speed safe and effective medical products to patients and maintain our nation's role as a leader in biomedical innovation," Department of Health and Human Services Secretary Kathleen Sebelius said in a statement.

As GenomeWeb Daily News reported when Congress passed the bill late last month, the extra funding for medical devices will enable FDA to hire more than 200 full-time employees to support the medical devices review program, on top of another 32 it already planned to hired before the end of 2012, and it will provide for enhanced training programs for staff.

The details of the MDUFA expansion were worked out through an agreement between FDA, industry representatives, and members of Congress over the past two years, and it requires FDA to implement new performance goals in its review processes.

The Advanced Medical Technology Association, or AdvaMed, recently said in a statement that the new user fees agreement "includes a series of strong, measurable performance goals and additional funding that should help reverse the decline in performance FDA has experienced in recent years."

Sebelius said that while the bill "marks an important moment for innovators across industry, research and clinical care settings, its most important beneficiaries are the patients and families that will be helped by the next generation of affordable medical products this bill will help to foster."