Congress has passed the FDA Amendments Act (FDAAA) of 2007 which reauthorizations of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA)-- two programs accounting for nearly one quarter of FDA's annual budget.

"Over the past years, the PDUFA and MDUFMA programs have resulted in significant public health gains by making safe and effective, yet increasingly complex, medications and medical devices available to patients faster than was previously possible," said FDA Commissioner Andrew C. von Eschenbach. The FDAAA broadens FDA's drug safety protection authority and provides for fuller disclosure of drug risks and side effects information.

FDAAA contains no major setbacks for the medical device industry's research, development and marketing of new technologies. It had been proposed that the FDA toughen pre- and post-market review of implantable devices, but that provision is not in the final bill. Device makers will pay higher user fees to the FDA, but these are aimed at speeding the review process for new technology.
"The passage of the FDA Amendments Act of 2007 is good news for patients, the FDA, and for medical technology. It will ensure patients continue to have access to safe and effective medical devices without unnecessary delays," said AdvaMed President and CEO Stephen J. Ubl. "This legislation also enhances patient safety by providing FDA's device program with the financial resources it needs to meet its medical technology review commitments, while protecting future FDA appropriations and providing manufacturers with predictability regarding user fee rates."

The new bill appropriates funds earmarked for pediatric device development. The legislation includes the reauthorizations of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act--two statutes that have provided invaluable information to the agency about medical products' interaction with pediatric populations. These programs are vitally important to the agency and its continued ability to protect and promote the public health, according to the commissioner.

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