The bill revises user-fee programs for prescription drugs and medical devices, and strengthens the role of the FDA with respect to postmarket safety of drugs and devices, and for other purposes.
Regarding devices in particular, the bill appropriates an additional $7,100,000 for fiscal years 2008-2012, plus an inflation adjustment. The resources are aimed at collecting, developing, reviewing, and evaluating postmarket safety information on medical devices.
The FDA's traditional role in safeguarding drugs and devices had focused on approval, with rigorous pre-market regulation to ensure safety and efficacy before products are prescribed and sold in the U.S. However, recent cases have called drug safety into question after approval and marketing, most notably in the case of Merck's VIOXX, pointing to the need for the agency to strengthen its role throughout the product lifecycle. VIOXX was voluntarily withdrawn from the market by Merck in 2004 following safety questions raised about its cardiovascular risk in a study of arthritis drugs.
Industry advocates applaud the PDUFA legislation. "House passage of this important piece of legislation is a victory for American patients as they will continue to have timely access to the latest medical technology advancements. HR 2900 will enhance 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," said AdvaMed President and CEO Stephen J. Ubl. "AdvaMed encourages the House and Senate leadership to quickly name members to a conference committee so that differences between the two chambers' versions of the legislation can be reconciled and a final bill sent to the President before the current user fee program expires on September 30, 2007." (AdvaMed, the Advanced Medical Technology Association, is a professional organization of medical device makers.)
A summary of selected provisions follows:
-Food and Drug Administration Amendments Act of 2007 - Prescription Drug User Fee Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize the collection of prescription drug user fees for FY2008-FY2012.
-Requires the Secretary of Health and Human Services to assess and collect fees for advisory review of direct-to-consumer television advertisements of prescription drugs.
-Medical Device User Fee Amendments of 2007: Reauthorizes the collection of medical device user fees for FY2008-FY2012. Sets forth provisions governing the inspection of medical device establishments by accredited persons.
-Pediatric Medical Device Safety and Improvement Act of 2007: Requires a person that submits an application for approval of a medical device to provide information on pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure.
-Provides special rules (Section 103) for positron emission (PET) drugs to be exempt from the annual establishment fee for some not-for-profit medical centers.
-Encourages the FDA to reconsider the termination of the Medical Imaging Drugs Advisory Committee (MIDAC).
-Requires the Secretary of HHS, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database for drugs and devices.
-Authorizes the Secretary to require a responsible person for a drug to conduct a post-approval study on the basis of scientific information.
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