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Presentation to the RDLA April 23, 2014

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

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Presentation to the RDLA April 23, 2014

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  1. Presentation to the RDLA April 23, 2014

  2. 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.”

  3. 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.

  4. 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.

  5. Budgetary Gauntlet, FY 15 Version • Within this overall schedule, Agricultural Appropriations likely to go early: • committee mark-ups in May; • target completion before August recess

  6. 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, agapprops 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

  7. 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.

  8. 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

  9. Patients, consumers, health professionals, industry....and the whole world benefits, too. A strong FDA benefits all Americans For more information, contact: Ladd Wiley, Executive Director Steven Grossman, Deputy Exec. Director lwiley@StrengthenFDA.orgsgrossman@StrengthenFDA.org 202-887-4083 301-539-9660

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