House approves Pitts bill to preserve popular, effective device program

Legislation fixes “trigger” that endangers program

Washington—The House of Representatives today approved legislation written by Congressman Joe Pitts (R, PA-16) and co-sponsored by Congresswoman Anna Eshoo (D, CA-14) that makes key changes to the Medical Device User Fee and Modernization Act (MDUFMA).  H.R. 3243, the Medical Device User Fee Stabilization Act of 2005, ensures MDUFMA is funded through its original authorization (2007) and continues to get life-saving medical devices into the hands of patients in timely fashion.

“MDUFMA is a necessary and effective program that gets life-saving medical devices to patients.  We’ve been working for more than a year now to get this issue taken care of.  I’m glad the House has acted so quickly on our bill.  I look forward to the Senate taking up this legislation soon,” said Congressman Pitts, whose district includes Reading-based Arrow International, Inc. and Medartis, Inc. in Kennett Square , both medical device manufacturers.

Original enactment of MDUFMA stemmed from concerns over the pace of the FDA’s lengthy review process of medical devices and the need for consumers to have more access and choice in a shorter period of time.  Before MDUFMA, applications for approval often languished at the FDA with no indication as to when they might be reviewed.  MDUFMA replaced the entirely government-funded device review process with a system funded with fees paid by the device manufacturers and congressional appropriations.  Since 2002, device approval time has been virtually cut in half.

“This program significantly reduces the time it takes to get life-saving medical technologies to the market without compromising safety," said Eshoo.  “Though this legislation only authorizes the program for two more years, it’s a significant accomplishment and allows us to now concentrate on making the device approval process even better in 2007.”

To ensure that the Agency receives all of the funding envisioned over the five year period, a “trigger” in MDUFMA terminates the user fee program on September 30, 2005 if the resources prescribed in the law are not realized.  While Congress provided the $216.7 million required by MDUFMA for FY05, the funding for fiscal years 2003 and 2004 is $40 million below the MDUFMA target. 

To prevent the “trigger” from sun-setting the program in September, H.R. 3243 amends MDUFMA to reduce the appropriations target for the program over the five year period.  It also brings added stability to fee increases and revenue thresholds until the original authorization expires in 2007, when MDUFMA must be reauthorized.

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