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.”

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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.

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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.

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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

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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

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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.

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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

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A strong FDA benefits all AmericansPatients, consumers, health professionals,

industry....and the whole world benefits, too.

For more information, contact:

Ladd Wiley, Executive Director Steven Grossman, Deputy Exec. Directorlwiley@StrengthenFDA.org sgrossman@StrengthenFDA.org 202-887-4083 301-539-9660