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Inside Health Policy – Alliance For A Stronger FDA: FDA Should Receive $2.8 Billion In FY 2018

Inside Health Policy – Alliance For A Stronger FDA: FDA Should Receive $2.8 Billion In FY 2018

An alliance of drug companies and research advocacy groups is calling for Congress to appropriate $2.8 billion for FDA in fiscal 2018 — a $78 million increase from fiscal 2016. The additional funds would help the agency keep up with growing responsibilities and could improve food safety, drug quality and implementation of 21st Century Cures, a spokesperson for the alliance told Inside Health Policy. The White House on Monday (Feb. 27) signaled it will seek deep funding cuts at most government agencies in order to pay for an increase in defense spending.

The request from the Alliance for a Stronger FDA comes as the agency continues to operate under fiscal 2016 funding levels as part of the Continuing Resolution passed in December. The spokesperson for the alliance expressed concern that Congress will further extend the CR, despite pending fiscal 2017 appropriations bills that would give FDA a $35-45 million funding increase.

Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, pointed to food safety, drug quality and further implementation of Cures as areas that would benefit from increased funding levels, but emphasized the alliance does not advocate for specific uses of funding.

“It’s always been our position that where the money specifically goes to is what the agency and Congress have to work out,” Grossman told IHP.

The Alliance pointed to the increasing responsibilities put on FDA by Congress as evidence of the agency’s need for additional funding. “The Congress has enacted a half dozen major laws for FDA to implement, science has grown increasingly complex (requiring more FDA expertise), all FDA-regulated products have become more global (requiring FDA to have an international presence), and the regulated industries have become larger (increasing FDA’s workload),” Grossman wrote.

However, Grossman emphasized that the alliance weighed the current pressure to cut federal spending in formulating its funding request. “Every year, when the Alliance formulates its ‘ask,’ we are put in the position of gauging how much additional funding FDA needs and what, reasonably, the appropriation process is likely to provide,” Grossman wrote. “It means that we usually aren’t asking for all the monies necessary to make FDA ‘whole’ relative to its responsibilities. In most years, that number would significantly exceed what we could credibly ask for.”

“We know that there will be strong and continued downward pressure on non-defense discretionary spending, starting with the remainder of FY 17 and going into the FY 18 funding cycle. At the same time, we know that just a few months ago, in the 21st Century Cures legislation, the Congress expressed its continued support of FDA and gave the agency even more responsibility,” Grossman added.

FDA would get a funding bump as part of the pending 2017 appropriations bill. Grossman hopes Congress will stick to the funding currently included in the bill, but anticipates that the CR could be further extended.

“I would say that we would hope they get to the House and Senate numbers which would give the agency a $35-$45 million dollar increase, which was what was in the House and Senate bills. If they don’t do another CR at the 2016 level, that’s what is reasonable to hope for,” Grossman told IHP.

The Alliance hasn’t received any budget materials from the Trump administration, Grossman told IHP, saying that he would be surprised if anybody has at the current time.

The $2.8 billion ask from the alliance does not include off-budget funding that FDA was promised by legislators to implement the 21st Century Cures Act, Grossman told IHP. “The Cures money is for very specific purposes,” Grossman remarked, saying the money is distinct from appropriations because it is targeted for specific uses.

“In addition to the $2.8 billion, we will also be advocating for the $60 million in off-budget funding for specific provisions of the Cures legislation. The Cures monies are not available for implementation of the rest of the Cures legislation or for other continued and growing needs of the agency in fulfilling its mission and responsibilities,” Grossman wrote.

The alliance’s board includes Pharmaceutical Research and Manufacturers of America, Pew Charitable Trusts, Johnson & Johnson, Advanced Medical Technology Association, Friends of Cancer Research, National Center for Health Research and others.…