Additional Investment = Substantial Added Value

Commissioner Gottlieb has repeatedly said: FDA can do more if given more resources. The Alliance has said something very similar: there are multiple opportunities for FDA to be a more effective protector of the public health, as well as a fairer and more efficient regulator. We are at a point where additional investment in FDA will result in substantial added value to the American public.Consistent with both of these sentiments, the President’s FY 19 budget request includes new medical product initiatives that would require more than $400 million dollars in additional taxpayer funding for FDA. The Alliance supports the request and is also asking for an additional $50 million for food safety programs.FDA would use the additional $400 million in medical product funding proposed by the President to strengthen the systems that guide and support agency decision-making and stimulate innovation. Among the items proposed:

• Improvements in drug and device manufacturing,
• Advances in the use of real world evidence in medical product development
• A knowledge management system to improve regulatory decisionmaking
• A new regulatory framework for digital health technology,
• Enhancements to research on rare diseases, and
• New systems to speed the introduction of cost-saving generic drugs.

The Alliance has met with Center directors to gain their understanding of what is planned. Our summaries of each meeting are here: CBER, CDER, CDRH,There are also opportunities -- not realized in the Administration’s budget proposal -- to do more to enhance the safety of our nation’s food supply. For this we recommend an additional $50 million above the FY 18 appropriated level for the food safety programs at FDA. Among other purposes, monies are needed for:

• Technical assistance for growers and other regulated parties,
• Strengthening the states’ ability to function as partners in FSMA implementation, an
• Advancing import safety and foreign and domestic port inspections to ensure that consumer health and safety is protected and U.S. producers enjoy a level playing field.

A recent meeting with Dr. Ostroff and the directors of CFSAN and CVM is described here: CFSAN/CVM.Finally, the Alliance’s “ask” includes $70 million in 21st Century Cures funding. We treat it as separate from our request for BA funding. When Congress adopted the 21st Century Cures legislation in December 2016, it set aside funds to pay for very specific projects detailed in the legislation. The funds came from savings from changes in mandatory programs and were put in a trust fund-type structure. The funds need to be appropriated but do not count against discretionary budget ceilings.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.