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Dr. Hamburg’s New Year’s Memo to FDA Staff

January 15, 2010

ADVOCACY

Agriculture Appropriators Meetings

  • The Alliance is set to meet with staff of members of the House and Senate Agriculture Appropriations Subcommittees in the first and second weeks of February.

Alliance Member Meetings

  • The first Alliance member meeting of 2010 is scheduled for Tuesday, February 9th at 2:00 pm.

ANALYSIS AND COMMENTARY

A week ago, FDA Commissioner Hamburg sent FDA employees a memo, expressing her thoughts on the New Year. It is an interesting look at 2009 accomplishments and provides insight on some of her priorities for 2010. A copy of the complete memo is available elsewhere on this web site. Here are some thoughts on the resource aspects of her letter:

Commitment to Resources. Throughout the letter, Dr. Hamburg praises FDA staff for their hard work and commitment. Near the beginning of the letter, she writes: “I recently observed to Secretary Sebelius that I have found FDA’s employees to be a wonderfully talented and dedicated group that I believed, if adequately resourced and supported, could solve virtually any problem that comes [y]our way.”

She follows through with this theme later in the letter, where she commits to getting FDA employees “the resources and staffing necessary to be successful … despite the demands to reduce Federal spending.”

The Alliance recommends that FDA get a $500M increase for FY 11. Of this, about $120M is needed to deal with increased personnel costs and other inflation in FDA costs. While we have worked for a solid Administration request, at some point, the Commissioner may have to defend numbers that are modest compared to these benchmarks.

The Alliance advocates for more appropriated funding for the agency year-round. Our voice becomes even more important a month from now … if the Commissioner is compelled to defend a President’s budget request that is inadequate for her vision of success (or ours).

New Mandates: In the letter, Dr. Hamburg acknowledges the impact of new (sometimes unexpected) program activities: “A cascade of new challenges were thrust upon us [in 2009] – H1N1 influenza, implementation of the new FDAAA and animal drug legislation, new food contamination and drug registration systems, and an entirely new Center to regulate tobacco for the first time in the nation’s history.” She added: “… lurking out there are new requirements in the health care bill moving through Congress (e.g., ‘follow on’ biologics and restaurant menu labeling).” Later in the letter, she references the pending food safety legislation and FDA’s commitment to its passage.

The Alliance has been concerned about the budgetary and resource impact of new mandates. As an appropriation-advocate, the Alliance is neutral as to the content of the mandates. What troubles us is how new mandates can wipe out seemingly large budget increases for the agency. For example, we would (all) be pleased if FDA received a $400M increase. However, if $120M is needed to maintain staffing of current programs and $200M is needed to support new mandates, then only $80M is available to strengthen the agency and offset the continued impact of a decade of lean years.

Regardless of the Administration request, we hope that the Commissioner will still be free to express her concern about the need for new and additional funding to cover the cost of new responsibilities.

Overall, the Commissioner is right to speak out now, as forcefully as she can. The President’s State of the Union address has not yet been scheduled. About 10 days after that, OMB will release the President’s request for FDA. Once that occurs, the Commissioner will have to stick to the script she is given.

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

MEDIA/NEWS

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