[Congressional Record (Bound Edition), Volume 151 (2005), Part 13]
[Senate]
[Page 17402]
[From the U.S. Government Publishing Office, www.gpo.gov]




           MEDICAL DEVICE USER FEE STABILIZATION ACT OF 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.

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