FDA Asks Congress To Renew Medical Device User Fees

FDA on Monday issued a proposal to Congress urging the reauthorization of the Medical Device User Fee and Modernization Act that would include increases in the fees the agency charges companies seeking federal approval for medical devices, the AP/Albany Times Union reports.

FDA says it needs the fees for its medical device review program to keep pace with the growing industry and changes in technology. Under the proposal, which the agency negotiated with the medical device industry, companies would pay 31% more in fees in 2008 and 8.5% more each subsequent year through 2012.

The $287 million in industry fees collected during that five-year period would account for about 23% of the more than $1.2 billion FDA estimates it needs to adequately review medical devices. Government funding would make up the difference (AP/Albany Times Union, 4/16). Additional fees would be charged for a variety of services, including the processing of applications for premarket approval of medical devices (Wall Street Journal, 4/17).

Fees also would be assessed on facilities that register with FDA as a medical device manufacturer.

In an effort to boost transparency, FDA said it would continue to encourage informal communication with companies and expand the kind of information it releases to the public. The proposal also would streamline the third-party inspection program and promote the development of in vitro diagnostic tests.

The proposal includes a set of specific performance goals that FDA would evaluate and report on each quarter.

The agency would make decisions on 50% of expedited premarket applications and supplement applications that are presented before an FDA advisory committee within 180 days. Ninety percent of those applications would receive decisions within 280 days.

FDA would decide on 60% of conventional premarket and supplement applications within 180 days and 90% within 295 days. In addition, FDA would decide on 90% of 510(k) applications for lower-risk devices within 90 days and 98% within 150 days.

Businesses with $100 million or less in annual sales or receipts would receive additional benefits under the proposal, including fee reductions for 510(k) applications and for premarket approvals and related supplement fees.

In February, FDA and AdvaMed -- the medical device industry's lobbying group -- reached an agreement in principle to reauthorize the act. FDA will take public comments on the regulation over the next 30 days and will hold a public meeting on April 30.

FDA Commissioner Andrew von Eschenbach in a statement said, "The proposal would give companies predictable fees and improved review times as well as provide FDA with a steady source of additional funding for its device review program."

AdvaMed President and CEO Stephen Ubl said, "This agreement is rightly focused on public health and safety first, while providing for improved agency performance goals to ensure timely and efficient patient access to lifesaving and life-enhancing medical technologies." He added, "Innovation in the medical technology is rapid, and this user fee agreement will provide FDA the resources it needs to prepare for the coming wave of 21st century medical technology" (Carey, CQ HealthBeat, 4/16).

In related news, Senate Health, Education, Labor and Pensions Chair Edward Kennedy (D-Mass.) has no plans to include a generic biotechnology drug bill (S 623) in his committee's consideration of the reauthorization of the Prescription Drug User Fee Act, according to an aide, Congress Daily reports.

Meanwhile, Sen. Hillary Rodham Clinton (D-N.Y.), a committee member who is sponsoring the measure with Sen. Charles Schumer (D-N.Y.), has not said whether she will offer the bill as an amendment to PDUFA at the markup scheduled for Wednesday (Johnson, CongressDaily, 4/17).