Presentation to the RDLA April 23, 2014

Alliance for a Stronger FDA Nearly 200 members Patient and consumer groups Health professional and research advocacy groups Industry groups and individual companies Individuals, including former commissioners Members are interested in every part of FDA, including drug development, medical devices, food safety, animal food and drugs and more Started in 2006 Primary Goal: increasing appropriated funding for FDA because “a strong, well-funded FDA is in the interest of all stakeholders.” 1

The FY 14 Baseline BA appropriations of $2.552 billion (S&E) and $9 million (B&F) House/Senate provided largest numbers under consideration Tops FY 12 by $55 million Appropriation of all user fees, totally $1.795 billion. Restoration of sequestered FY 13 user fees, totaling $79 million (non-BA, one-time funds) Acceptance by the appropriations committees that: : The agency’s mission and responsibilities are not static. New laws to implement and continued growth in globalization, scientific complexity and regulated industries. 2

The Administration FY 15 Request Mostly preserves the FY 14 base Claims 8+% increase that is mostly proposed user fees that no one thinks will become law FDA’s food safety activities would gain $23 million in appropriated funding, but have about $15 million less from existing (current law) user fees than in FY 14. FDA’s medical products programs would receive no net increase in appropriations. Even the Administration’s proposal for $25 million to implement regulation of pharmacy compounding is coming from other program activities, not new monies. 3

Budgetary Gauntlet, FY 15 Version March 2014: President Submitted FY 15 Budget Request March/April 2014: Appropriations Committee Hearings May-July 2014: Committee Mark-ups FY 2015 Appropriations: Complete or CR by September 30 Within this overall schedule, Agricultural Appropriations likely to go early: committee mark-ups in May; target completion before August recess

Prospects for FY 15 Overall non-defense budget virtually level (no growth) 302(b) allocation not yet set—primary determinant of whether Ag approps has any new monies to spend House/Senate will not preconference allocations House/Senate may have different ag allocations If House allocates money away from HHS (seen as likely), then Ag subcommittee may have more to spend that it will in the Senate Possibility that House might produce higher FDA numbers Relative to FY 14 base, ag approps expects to have mandatory, formula and technical reasons why some programs will automatically cost more in FY 15 Strong sentiment to preserve FDA’s gains, but staff mostly non-committal about more until allocations are made 5

Consequences of a Resource-Limited FDA FDA’s vital, complex world-wide public health responsibilities cannot be accomplished within its existing budget FDA is a staff-intensive organization. More than 80% of its budget is devoted to staff-related costs. If the agency budget fails to grow over the next few years: problems with imports and globalization will become more numerous, drug and device reviews will be slower, conflicting with promises made to consumers and companies, critical efforts to modernize the agency and improve its support for innovation will stall, and food will be less safe and consumers put at risk. 6

Our Work and Results Successful advocacy for more FDA resources Consistent and organized advocacy for FDA resources The definitive source for information on FDA’s budget: Congress and the Administration look to the Alliance for one-stop shopping on budgetary impact on FDA The press counts on the Alliance for quick and accurate analysis Industry, Patient and Consumer Groups trust the work they do together with the Alliance Working to create a long-term well-educated constituency for FDA in Congress 7

A strong FDA benefits all Americans Patients, consumers, health professionals, industry....and the whole world benefits, too. For more information, contact: Ladd Wiley, Executive Director Steven Grossman, Deputy Exec. Director