The two-year budget deal that has passed both the House and Senate will have positive financial impact on the FDA. The bill prevents another government shutdown this fiscal year and provides some relief from sequestration of government funds over the next two years.
Importantly, the bill will allow FDA full access to company-paid user fees in fiscal years 2014 and 2015, rather than having a percentage of the fees sequestered. The deal will leave it up to congressional appropriation to distribute the funding to different agencies and activities, which is good for the FDA, according to Steve Grossman, executive director for the Alliance for a Stronger FDA. “The most important thing for the FDA was for the process to go back to the appropriations committees,” says Grossman.
The bill also contains language that supports the repeal of the 2.3% medical device tax. This language is non-binding and does not repeal the tax. However, it does provide the medical device industry with another opportunity to build a bipartisan coalition to repeal the tax. The challenge remains finding a budget offset to pay for the loss of revenue from the medical device tax.
The bill supporters underscore the importance of creating some stability to government funding, which has been lacking. This should help prevent future government shutdowns, which had a significant impact on FDA operations.
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