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The Friday Update — November 13, 2009

November 28, 2009

ADVOCACY

Metrics Working Group Teleconferences. This past week the Alliance Drugs/Biologics, Food, and Device Subgroups held working group teleconferences.  Each group will reconvene in two weeks.  Details regarding each working group teleconference will be provided early next week.   

  • E-mail Ballots for Directorships. Members have been sent e-mail ballot forms to elect the directors of the Alliance for 2010.  For those who have not done so, please cast your vote by responding either “yes” or “no” to the proposed slate of directors.

THE GROSSMAN ANALYSIS

FDA is definitely on a roll.  Thanks in part to our efforts, its budget has grown from $1.57 billion to $2.35 billion. The Alliance is recommending another $500 million increase for  FY 11 for FDA.  Our advocacy will be aided by a new appreciation for the agency on Capitol Hill, at the White House and in the media.

Still, we expect to face a difficult year as the FY 11 budget moves from OMB to the Congress. Here are at least three challenges we will have to overcome:

Unfunded mandates are moving forward. A regulatory pathway for follow-on-biologics (FOB) is likely to be in the final version of health reform legislation. Separately, it looks like food safety legislation will be passed and become law in the next few months. There is a problem with “mission creep” at FDA — new assignments for the agency that come without new funding to pay for them. At least for FY 10, this seems to involve incremental items. In contrast, FDA costs for implementing FOB or food safety improvements are likely to be enormous. CBO estimated that the House-passed food safety legislation would cost $1 billion per year in its fifth year and that figure is net of new user fees. We will need to advocate for food safety and FOB funding above our requests for monies to strengthen the agency.

We could get lost in the implementation of health care reform. Other important legislation was put aside this year because of the urgency and comprehensiveness of the health reform legislation. Once the President signs final legislation, a similar effect is going to happen in the Executive Branch as it works to implement an overhaul of our entire health care system. In general, FDA is getting more attention and more appreciation. Post-health care reform, it  may get less.

FY 2011 will be a year of budget-cutting. Here is a key item from this morning’s Politico: “President Barack Obama plans to announce in next year’s State of the Union address that he wants to focus extensively on cutting the federal deficit in 2010 – and will downplay other new domestic spending beyond jobs programs.” Further, the Wall Street Journal reported that Cabinet agencies are being asked to submit two budgets to the White House: one to freeze spending at current levels, the other to trim total spending by 5%.

The Alliance has done well so far, but it will take more than momentum to increase the appropriations for FDA in the FY 11 budget cycle.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance.

MEDIA

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