FDA User Fee Act Passes Congress, Awaits President’s Approval
Posted on June 27, 2012 @ 10:02 am
U.S. Congress has passed the Food and Drug Administration Safety and Innovation Act (S. 3187), which is intended to improve the efficiency and predictability of the U.S. Food and Drug Administration’s (FDA’s) review process. It remains now only for President Obama to sign and approve the legislation so it can be implemented.
Industry executives are pleased with the result of what has been a long road for this bill:
Housed within the legislation is the Medical Device User Fee Act (MDUFA), effectively a renewal of the Medical Device User Fee and Modernization Act (MDUFMA), originally passed in 2002 and then reauthorized in 2007.
MDUFMA had four main objectives:
One of the main objectives of MDUFA is speeding up the FDA review process via increased user fees, which med tech companies are more than willing to pay if it means faster device approval or clearance times. Some of MDUFA’s new provisions include:
S. 3187 also includes new provisions and rules for the pharmaceutical industry, including directives for the FDA to inspect foreign drug facilities that produce drugs for use in the Unites States.
S. 3187 passed in the House on Tuesday June 26 2012 by a vote of 92-4. Throughout its journey, the medtech industry has been praising the act as a rare example of bipartisanship on Capitol Hill.
“This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency,” said Stephen J. Ubl, Advanced Medical Technology Association (AdvaMed) president and CEO. “That means more American patients will have access to safe and effective treatments and diagnostics sooner, which is the shared goal of both FDA and industry.”
AdvaMed Chairman and Zimmer CEO David Dvorak had a warning for the industry:
“The legislation … is only the beginning. It will require consistent and effective implementation by FDA, which will be held accountable to meeting all of its commitments.”
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