Medical Device User Fee Stabilization Act of 2005

MEDICAL DEVICE USER FEE STABILIZATION ACT OF 2005 -- (Senate - July 26, 2005)

Mr. KENNEDY. Mr. President, I strongly support the Medical Device User Fee Stabilization Act of 2005.

The bill makes needed corrections in the Device User Fee Act we passed in 2002. Most important, it extends this worthwhile program beyond September 30. It ensures stable growth for individual user fees by limiting increases to 8.5 percent a year in 2006 and 2007, and it raises the threshold for businesses to be eligible for the reduced small business fees from $30 million to $100 million.

The user fee program has provided much needed support for the Food and Drug Administration over the past 3 years to expedite its review of medical devices. The FDA has improved its ability to review devices more quickly, and laid the groundwork for further progress as well. Unfortunately, however, fees on individual applications have climbed rapidly in the past 3 years--much faster than anticipated.

Our bill maintains this valuable program and limits the rate of growth in fees. It strikes a fair balance between the competing interests of FDA and the various industries. The agency is not guaranteed the growth in fees that it received under the original legislation to meet the need to expedite its reviews. It makes sense to limit fee increases in response to the concern that the fees have climbed too quickly and are discouraging innovation in these valuable devices. That is why we call the bill the User Fee Stabilization Act.

The bill also clarifies the provision in current law on the identification of the makers of single-use medical devices. Adverse event reports should not be inaccurately attributed to the wrong company, and doctors should not be misled about the source of the device.

Since many so-called single-use devices are often reprocessed and used again, the legislation requires reprocessors of single-use devices to identify their role in preparing the device. When the manufacturer of the original device is identified on the device, the reprocessor must do so as well. When the manufacturer of the original device has not done so, the bill permits the use of detachable labels on the package of the reprocessed device, so that the label can be placed in the patient's medical chart.

These provisions will become effective 12 months after the date of enactment, and they are a reasonable compromise of the interests of the FDA, the original manufacturers, and the reprocessors.

I commend Chairman Enzi for his leadership in producing this much-needed legislation, and I welcome the strong, bipartisan support for the bill in our Health Committee. I urge all my colleagues to support this important legislation, so that this valuable medical device program can continue effectively beyond September 30.

http://thomas.loc.gov/