February 25, 2015 by Val Kennedy
Industry trade association AdvaMed applauds a bill introduced into the U.S. House of Representatives that would protect FDA user fees from sequestering cuts.
Industry trade association AdvaMed said Wednesday it applauds a bill introduced into the U.S. House of Representatives that would protect FDA user fees from sequestering cuts.
The bill was introduced by Rep. Leonard Lance (R-N.J.) and Rep. Anna Eshoo (R-Calif.) Under the Medical Device User Fee Amendments of 2012, the FDA is empowered to collect fees from medical device makers to help expedite the product approval process.
“We have long maintained that user fees paid by industry to FDA should not be treated under sequestration the same way as taxpayer dollars. The fees paid by medical technology companies under the 2012 Medical Device User Fee Agreement represent an agreement between industry, FDA and Congress. Under that agreement, industry agrees to supplement FDA’s appropriated budget with user fees, and the agency agrees to performance commitments designed to increase the efficiency and predictability of the review process,” said Stephen Ubl, AdvaMed’s president and CEO, in a statement issued Wednesday.