[Congressional Record Volume 151, Number 104 (Wednesday, July 27, 2005)]
[Extensions of Remarks]
[Pages E1633-E1634]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           MEDICAL DEVICE USER FEE STABILIZATION ACT OF 2005

                                 ______
                                 

                               speech of

                          HON. JOSEPH R. PITTS

                            of pennsylvania

                    in the house of representatives

                         Tuesday, July 26, 2005

  Mr. PITTS. Mr. Speaker, before 2002, the government funded the 
approval process for pacemakers, catheters, defibrillators, contact 
lenses, hip prosthetics, and other medical devices using only taxpayer 
funding.
  This publicly funded process was a mess. It significantly delayed 
Food and Drug Administration approval of new, life-saving medical 
devices and prevent patients from benefiting from this new technology. 
To end this delay, Congress unanimously passed The Medical Device User 
Fee and Modernization Act in 2002. MDUFMA overcame obstacles at the FDA 
that prevent timely approval of new life-saving medical technologies 
without compromising the safety of consumers.
  Modeled after a similar program used to approve medicines and 
pharmaceuticals, MDUFMA created a stable funding base for the FDA. It 
combines industry paid user fees and Congressional appropriations. As a 
result,

[[Page E1634]]

the device approval time has been virtually cut in half. The program 
proved very popular among companies making these devices and the 
patients who have benefited from them.
  However, Congress built a trigger into the law. The trigger sun-sets 
the program on September 30, 2005 when Congress fails to appropriate 
the amount authorized under the 2002 law. Congress provided the $216.7 
million required in fiscal year 2005. But in 2003 and 2004, Congress 
shortchanged MDUFMA by $40 million. That shortfall will cause MDUFMA to 
expire on September 30th. We can't allow that to happen. Too much is at 
stake.
  H.R. 3243 renews MDUFMA for two years and brings some much needed 
stability to the program. In 2007 we will revisit a full 
reauthorization of MDUFMA and finetune the program. I urge my 
colleagues to support this bill. I'd like to thank my colleague, the 
gentlewoman from California, Ms. Eshoo, for her hard work on this 
legislation.

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