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“Please Congress, We Want Some More!”

March 14, 2014

The Office of Management and Budget was created more than 90 years ago. Its early development was guided by President Calvin Coolidge, an ardent supporter. He had three goals: a unified federal budget, focusing federal departments on limiting expenditures, and pushing the then-new concept that departments had an obligation to advocate what was allotted to them in the President’s budget request rather than use their own calculations.

I mention this history for a reason. FDA’s budget request — no matter how ardently they advocate for it — is not necessarily a reflection of what the agency needs. Rather, what emerged from OMB last week as the FDA’s FY 15 budget request is the culmination of an 18-month process. It starts at the office level and works its way up to the centers and then to the Commissioner’s office. There is then a negotiation with HHS and a further negotiation (through HHS) with OMB.

What results from this process may be close to what the FDA actually thought it needed, but it is generally safe to assume it is significantly less. The agency’s 200-page, detailed budget justification notwithstanding, what emerges each year from FDA (and every other federal agency) is the result of a needs-based program assessment that has been wrung several times through a political process.

So, when the Alliance decides that the President’s budget request for FDA is too small, we are not being critical of the agency. To ask for more when it is needed … is respectful of the agency and the excellent work it does.

Yesterday’s announcement of the Alliance’s FY 15 budget request — $200 million more than the President’s request — needs to be seen in this light. Almost by definition, Alliance members are supporters of the FDA and agree that its vital purposes needs be better funded.

Our primary concern about the President’s request is that it is essentially flat funding:

  • 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. Existing user fees would increase by $57 million, but this is spread across eight programs and such monies are dedicated  to specific purposes. User fees are in no way a replacement for appropriated funds.
  • FDA proposes $24 million more for food safety (FSMA) and $25 million for pharmaceutical compounding (Drug Quality and Security Act), neither of which can be fully funded without undercutting the existing base of activities.
  • Nothing in the budget accounts for the increasing responsibilities of the agency: new mandates, food and medical product safety, globalization, increased scientific complexity, stimulating innovation, and larger industries generating more reviewable/inspectable items.

In sum, the President’s FY 15 budget request will leave FDA programs with more responsibility and less money than it had in FY 14.

This cannot go unchallenged. We ask all Alliance members to make increased FDA funding part of their advocacy this year. Further, we need your support for our collective activities, such as participating in our Hill Lobby Day and submitting written testimony to the House and Senate subcommittees (details are given in this week’s Advocacy at a Glance).

An essential part of our credibility is that we represent the broad cross-section of FDA stakeholders. Not only is there no similar organization working on FDA’s behalf, there is no federal public health or regulatory agency with the same breadth of support. Together, we can turn that into more funds and a stronger FDA.

Note: This week’s analysis and commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA

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