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Can FDA Withstand the FY 11 Budget-Cutters?

Tradition says nothing happens between Thanksgiving and New Year’s Day.  People check out mentally and, as often as possible, physically. Not this December, not in Washington, DC.

Most attention is on the US Senate, which is working this weekend and remains under threat of “no days off” until healthcare reform legislation passes. Just as intensely, but much less visibly, the Executive Branch is working full-tilt to complete the President’s Budget Request for FY 11 prior to the State of the Union speech in late January.

Of the two December activities, the President’s budget is far more important to FDA.

The President’s FY 11 budget request is likely to be deeply constrained. Having advocated successfully for a number of costly initiatives, President Obama will need to show that he can also reduce the deficit. He asked Cabinet secretaries to submit their budget requests at a no-growth level and an alternative budget on the assumption that their Department might be reduced by 5% overall.

With Congressional elections less than a year away, Congress will also feel pressure to dramatically reduce government spending. This will be particularly acute for Democrats, because the President’s party usually loses a substantial number of seats in the mid-term elections.

Much of the government is likely to be flat-funded in the President’s budget request. Even agencies and programs that advance Democratic policy priorities may not get increases.

There are three other reasons why FY 11 may be a rough year for FDA funding:

  • a number of unfunded mandates (FOB, food safety) in upcoming legislation may consume FDA’s budget increases ($300M is not an increase if the agency gets $400M in new responsibilities),
  • FDA could get lost in the funding and implementation of health care reform, and
  • increases over the last three years may be seen as sufficient to tide the agency over during a difficult budget year.

FDA’s fate on FY 11 appropriations is not sealed. It will require many good arguments and hard work for the agency to get a meaningful increase in the year ahead.

The Alliance for a Stronger FDA will continue to lead the fight to get the agency more funds. Since the Alliance’s founding three years ago, FDA’s budget has increased by nearly $800M, a 50% increase. (FY 10 compared with FY 07).

The Alliance has 180 members, representing all FDA stakeholders: consumers, patients, associations, companies and individuals. They all agree that the agency needs to be better funded. Three former Secretaries of Health and Human Services and 6 former FDA commissioners support the Alliance’s efforts and are honorary members.

If your organization, company, association, law firm or consulting firm are not members of the Alliance, please contact me at sgrossman@StrengthenFDA.org for details about joining. The Alliance also has individual memberships for those not associated with an organization.

The broader and deeper the Alliance membership, the more successful they can be. If FDA matters to you, please act now to help strengthen the agency through increased appropriations.


In the interests of disclosure, I am one of the founders of the Alliance and serve as its Deputy Executive Director. FDA Matters represents only my own views and is a product of my health policy and regulatory consulting firm, HPS Group, LLC. The Alliance and HPS Group are not affiliated in any way.

My last column on appropriations addressed FY 10’s successful efforts…and examined one of the key long-term concerns: FDA’s need to show that new monies have been well-spent in ways that support and promote the public heath:

To Whom Much is Given, Much is Expected
October 6th, 2009

There is good news to report now that House-Senate conferees have finalized work on FDA’s FY 10 budget. FDA received $306 million (15%) more to spend this fiscal year. Every center will have more resources to work with (see table at the bottom of this article).

This is the third good year for FDA, after years of bad ones. The agency is still severely underfunded, but progress is finally being made. Now the hard work begins: spending the new money wisely and showing that it has been used to accomplish important public health missions. Read the rest of this entry »

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