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Contacts:
Pitts,
Eshoo bill renews program for life-saving medical devices Legislation
fixes “trigger” that endangers popular program “Congress unanimously passed the
Medical Device User Fee and Modernization Act (MDUFMA) in 2002,” said
Congressman Pitts. “The law
overcame obstacles at the FDA that prevented timely approval of new medical
technologies. However, because
Congress has not fully funded the program a ‘trigger’ in the original
bill has slated it for expiration. We
can’t allow that to happen. It’s
simply too important and too effective in getting patients life-saving
medical devices.” Original enactment of this legislation
spurred from concerns over the pace of the Food and Drug Administration’s
lengthy review process and the need for consumers to have more access and
choice in a shorter period of time. This
law replaced the entirely government-funded device review process with a
system partially funded with fees paid by the manufacturers of the new
technologies. Because of this legislation, the device approval time has been
virtually cut in half. “This program has significantly
reduced 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.” In response to complaints that the Food
and Drug Administration (FDA) did not have the resources to approve the sale
of medical devices in a timely fashion, Congress unanimously passed the
Medical Device User Fee and Modernization Act (MDUFMA) in 2002.
Modeled after a similar program used to
approve medicines and pharmaceuticals, the program became become popular
among medical device manufacturers. Before
MDUFMA, applications for approval often languished at the FDA with no
indication as to when they might be reviewed.
MDUFMA changed that by injecting resources into the FDA, enabling the
agency to review and respond to these applications. MDUFMA provided these resources by
creating a stable funding base for device review programs through a
combination of industry-paid user fees ($150 million) and increased
appropriations for the Agency ($75 million) over five years.
To ensure that fees are additive and
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 is $40 million below the MDUFMA target due to shortfalls
in FY03 and FY04. To prevent the
“trigger” from sun-setting the program in September, Congress must amend
MDUFMA to reduce the appropriations target for the program over the five
year period. The Medical Device User Fee
Stabilization Act of 2005 amends Section 738 of the Food, Drug and Cosmetic
Act (Authority to Assess and Use Device Fees), by, among other things:
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