Congress Passes Bill to Reauthorize MDUFMA

The House and Senate last week passed a bill reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA), as well as a similar program for prescription drugs.
    The Senate passed the bill, H.R. 3580, Sept. 20 without amendment through unanimous consent procedure. H.R. 3580, the FDA Amendments Act, passed the House Sept. 19 by a vote of 405-7. The legislation now moves on to President Bush’s desk for approval.
    Without the bill, the user-fee program expires on Sept. 30, and FDA Commissioner Andrew von Eschenbach recently had informed FDA staff that if the bill did not pass before Sept. 21, 2,000 agency employees could be affected.
    “We are particularly pleased that Congress has completed the reauthorizations of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act—two programs accounting for nearly one quarter of FDA’s annual budget,” von Eschenbach said in a statement. “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.”
    According to Steve Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), in Washington, DC: “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. 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.”