As an 11th-hour budget deal shapes up for votes in the House and Senate this week, AdvaMed president and CEO Stephen J. Ubl lauded parts of the agreement that call for relief of the FDA user fee sequestration.
The negotiated budget, announced late Tuesday by House Budget Committee Chairman Paul Ryan (R-WI) and Senate Budget Committee Chairman Patty Murray (D-WA), would allow the FDA to access full user fees paid by the industry for the next two years. The mandatory budget cuts, which took effect in March this year, have cost the U.S. regulatory authority $2.9 million in user fees already, funds Ubl wants to see returned.
With these fees in place, the FDA maintains part of its overall cost of conducting the regulatory process. Without them, it's likely services would suffer. That could lead to longer waits for new med tech studies and approvals. Overall for fiscal 2014, the agency has proposed a $4.7 billion budget.
"AdvaMed believes user fees paid by industry to FDA should not be treated the same way as taxpayer dollars," Ubl wrote on behalf of AdvaMed. "We urge Congress to advance a permanent solution in January to allow FDA to access all user fees paid by industry, and we support efforts to release those FY 2013 user fees the agency has been unable to utilize."
The Medical Device Manufacturers Association (MDMA) also chimed in, focusing on hitches in the FDA process in their own statement in support of the deal.
"(I)t is crucial that FDA has access to all industry provided user fees so that it can provide a more reasonable and predictable regulatory framework," MDMA CEO Mark Leahey said on the organization's behalf. "Sequestration of these privately paid user fees was an unfortunate consequence that needs to be fully addressed to help ensure America's medical technology industry can continue to be the global leader."
Also called for by the proposed budget deal is a repeal of the 2.3% device tax included in the Affordable Care Act, which both AdvaMed and MDMA have been more than outspoken against in the past.
- here's the AdvaMed release
- and MDMA's statement