Budget Accord Should Increase FDA Funding, Free Up User Fees
This article was originally published in The Gray Sheet
The deal, which sets total FY 2014 discretionary spending at $1.012 trillion, leaves specific appropriations up to congressional committees and frees up user fees from sequestration for two years, both positive developments for FDA’s financial health. Device groups also tout a non-binding provision to repeal the device tax.
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Senate Finance and House Ways and Means Committee lawmakers issued a revised proposal to overhaul the physician payment sustainable growth rate formula in advance of a Dec. 13 markup. In response to public comment, lawmakers included more restrictions on which imaging services might be subject to appropriate-use criteria requirements.
Despite being a factor in lawmaker discussions throughout the shutdown, provisions to delay or repeal the device tax did not survive in the final agreement to reopen the federal government and raise the debt ceiling. But the issue appeared to gain more momentum than ever that companies hope can be maintained into upcoming budget conference talks.
New PMA and 510(k) submissions, and anything else tied to an FY 2014 user fee payment, are not being reviewed by FDA as of Oct. 1. The limited carryover-FY 2013 user fees FDA has are supporting ongoing reviews, while the registration and listing and export certification database entry systems are unavailable.