[Congressional Record (Bound Edition), Volume 151 (2005), Part 13]
[Senate]
[Pages 18196-18197]
[From the U.S. Government Publishing Office, www.gpo.gov]




           MEDICAL DEVICE USER FEE STABILIZATION ACT OF 2005

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of H.R. 3423 which was received 
from the House.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The assistant legislative clerk read as follows:


[[Page 18197]]

       A bill (H.R. 3423) to amend the Federal Food, Drug, and 
     Cosmetic Act with respect to medical device user fees.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. ENZI. Mr. President, I rise today to voice my support for the 
Medical Device User Fee Stabilization Act of 2005. This legislation 
preserves a valuable program for the review of innovative medical 
technologies.
  This bill, H.R. 3423, is identical to S. 1420, which was reported 
last week by the Committee on Health, Education, Labor, and Pensions. 
It represents a bipartisan, bicameral compromise that had unanimous 
support when it was reported out of the committee. It keeps an 
important Government program going, while providing more stability for 
the industry. We have considered the needs of small and large 
businesses, all while ensuring that FDA has enough resources to 
maintain a high level of effectiveness.
  This compromise results in an 8.5 percent increase in user fees for 
each of the next 2 years. This is a significant reduction from the 20 
percent annual increases these companies have been seeing. We have also 
raised the small business threshold more than threefold, from $30 
million to $100 million. This means that additional companies will be 
able to take advantage of reduced fees for the review of new devices. 
This bill will result in an average increase to FDA of 6 percent in 
user fee revenues over the next 2 years, which means FDA will be able 
to continue reviewing new devices and will not be forced to lay off 
experienced FDA staff or wind down a program that has been successful.
  Finally, this compromise clarifies a provision in the 2002 medical 
device law regarding the marking of reprocessed devices. I know that 
this provision, and any change to it, is controversial. However, we 
have found a fair way forward. The bill we are considering today would 
require reprocessors to mark the device to identify the reprocessor, if 
the original manufacturer has marked the device. If the original 
manufacturer has not marked the device, the reprocessor must still mark 
the device but has more flexibility in how to do so. This is workable, 
and it is even-handed.
  My colleagues, Senators Burr, DeWine, Mikulski, Dodd and Murray, have 
had great interest in the medical device user fee program, and I thank 
them for cosponsoring the Senate bill.
  I would also like to thank Senator Hatch for his attention and input 
into this issue. He is a strong defender of the small, entrepreneurial 
companies in this industry. We worked together before committee 
consideration of this bill to address his concerns about the impact of 
user fees on the innovative companies in his home State of Utah. I 
welcome his support and cosponsorship of the Senate bill.
  Of course, I want to thank our staff for laboring so diligently to 
find a workable, reasonable compromise and doing so under difficult 
time constraints. In particular, I want to thank Jennifer Hansen, Abby 
Kral, Ellen-Marie Whelan, Ben Berwick, Anne Grady, Patricia Knight, and 
Patricia DeLoatche. I also want to thank my committee staff Amy 
Muhlberg and Stephen Northrup.
  Finally, I must express my deep appreciation and thanks to the 
ranking member, Senator Kennedy, and his staff, David Bowen and David 
Dorsey, for their hard work and support during this process. We have 
produced a fair deal, and I urge my colleagues to lend it their strong 
support.
  Mr. McCONNELL. Mr. President, I ask unanimous consent that the bill 
be read a third time and passed, the motion to reconsider be laid upon 
the table, and any statements relating to the bill be printed in the 
Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (H.R. 3423) was read the third time and passed.

                          ____________________