Article: User Fees and Medical Device Reviews

By Carol Lewis

For the past decade, manufacturers of drug and biologics products have been required to pay a user fee to the Food and Drug Administration when applying for approval of new medicines and treatments. The additional resources, in turn, have been used to improve the efficiency and quality of product reviews. The success of the law, called the Prescription Drug User Fee Act (PDUFA), prompted Congress to approve similar legislation that requires user fees to be paid by medical device manufacturers.

"FDA's successful user fee program for pharmaceuticals has shown that a good user fee program can reduce time to market for safe and effective products without compromising safety and effectiveness," Health and Human Services Secretary Tommy G. Thompson says of the program.

Passed by Congress in October 2002, the Medical Device User Fee and Modernization Act (MDUFMA) amends the Federal Food, Drug, and Cosmetic Act, improving the FDA's ability to provide access to safe and effective medical devices. With the fees authorized by the new law, the FDA will hire more reviewers, make greater use of expertise outside the FDA, and streamline product review processes, particularly for breakthrough technologies. In return, manufacturers must ensure that premarket applications are complete and contain the data needed for a thorough product review.

The user fees provided by MDUFMA, and the additional appropriations that go with the new law, will provide three significant benefits:

• Safe and effective medical treatments will reach patients more rapidly.
• Medical device approval applications will receive timely, high-quality reviews.
• Devices marketed in the United States will continue to meet high standards for safety and effectiveness.

User Fee History

Concerns about the FDA's lengthy and thorough approval processes date back to the 1980s, when some critics complained that long review times were denying the American public the benefits of new drugs that were available in other developed nations months--or even years--earlier. To address concerns about the timeliness of reviews, the FDA, the drug industry, consumer groups, and Congress worked together to develop PDUFA. Enacted in 1992, the law replaced the entirely government-funded drug review process with a system partially funded by fees paid by the pharmaceutical industry. The resources provided by PDUFA have given the FDA the capability to more quickly decide whether new drugs and biologics should be approved for the marketplace.

While drug and biologics review budgets increased in recent years and review times decreased due to funds from user fees, resources for the FDA's medical device program have been reduced, and there have been indications that review performance has declined, even as the volume of work grew substantially.

PDUFA's example convinced medical device firms that user fees will provide the FDA with the additional resources and capabilities needed to deliver timely decisions in an era of rapidly advancing medical technology.

Improved Performance

Both consumers and the medical industry will benefit from MDUFMA. A stable source of funding will enable the FDA to expedite review of medical devices, and thus reduce time to market for industry. It also will give consumers earlier access to innovative treatments, with greater choice among products. User fees will foster innovation in medical technology by providing FDA reviewers the tools and skills they need to keep pace with rapid developments and innovations by the medical device industry.

MDUFMA has three particularly significant provisions:

• User fees for premarket reviews
  Revenues from these fees will allow the FDA to pursue a set of ambitious performance goals. Improvements in the review process will allow earlier and more effective interaction with product sponsors and greater understanding of new product technologies. These improvements are expected to speed the review of product applications. The performance goals FDA will pursue are set out in letters from HHS Secretary Thompson to Congress. A small business (for fiscal year 2003, sales and receipts of $30 million or less) may pay a reduced fee. The payment of a premarket review fee is not related in any way to the FDA's final decision on a submission.
• Third-party inspection program
  Manufacturers with a good compliance history would be permitted to select an FDA-accredited, non-government entity to perform some quality systems inspections. The FDA currently performs all of these inspections. The program is expected to help multinational firms meet their inspection requirements by using accredited third parties. This will permit the FDA to focus more of its own inspection resources on firms with greater problems and devices that pose greater risks. The new law contains stringent conflict-of-interest standards to ensure that third-party inspectors have no financial interest in the firm, the products being inspected, or any product that the FDA regulates.
• New regulatory requirements for reprocessed single-use devices
  New procedures will ensure that a reprocessed medical device--a device that has been cleaned, sterilized, and made ready for another use--will be safe and effective. The requirements are intended to provide users with information about whether the devices they use are reprocessed, and to provide the FDA with adequate information about whether a medical device can be cleaned, sterilized, and reused without adversely affecting its performance.

For more information on MDUFMA, see:

• Medical Device User Fee and Modernization Act of 2002
• Information on the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 (Center for Devices and Radiological Health)
• Medical Device User Fee and Modernization Act of 2002 (Center for Biologics Evaluation and Research)
• Chart describing the MDUFMA fee structure and initial fees