MEDICAL DEVICE USER FEE STABILIZATION ACT OF 2005 -- (Extensions of Remarks - July 27, 2005)
HON. JOSEPH R. PITTS
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, 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.