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.

Because FDA has been shortchanged for so long, it is almost unfair to expect results in anything less than 3 to 5 years. However, Congress will only be patient for so long. FDA and Dr. Hamburg don’t have much time to produce serious improvements.

Even acknowledging that a vastly larger appropriation is still needed, it is understandable why Congress won’t wait very long before expecting results:

• In the past two fiscal years (since FY 08), the budget for food programs has increased by more than 50%. Much of the extra money is allocated for field activities (inspections and enforcement).
  
• Budgets for CDER, CBER and CDRH have all grown by more than 30% in the last two fiscal years.
  
• The overall agency appropriation has increased by $776 million over the last three fiscal years (since FY 07). The represents a 50% increase in funding.
  

Dr. Hamburg and Dr. Sharfstein are responsible for moving the agency forward. Congress and the American people will hold them accountable.

They can’t do it alone. FDA staff is smart, committed and largely effective. Yet, territorial behavior is fairly common and creates multiple problems. The Commissioner must create a vision of the agency that gives FDA employees a reason to work for the entire agency, not just for their own division or unit.

“To whom much is given, much is expected” applies to all of FDA. It will take a team effort to meet the lofty, but legitimate, expectations that have been created.

——————

In prior columns, I have focused on other aspects of the appropriation process. Here is an update:

• FDA’s Office of Regulatory Affairs (ORA) receives more appropriated funding (about 1/3 of the total) than any other part of FDA. For FY 10, appropriated funding directed to ORA increased by 20% to $847 million. This situation led me to dub the head of ORA as The Uncrowned Prince of FDA, at http://www.fdamatters.com/?p=499.
  

• Unfunded mandates are a continuing concern for FDA, threatening the funding progress that has been made over the few years. Pending legislation (e.g. food safety reform) has not advanced since I last wrote on this topic. On a smaller scale, the FY 10 conference report adds $7 million to cover some new program requirements, in effect acknowledging that these would otherwise be unfunded mandates. My column, Unfunded Mandates Threaten FDA, is at: http://www.fdamatters.com/?p=375.
  

Steven

The House-Senate conference report can be found on pages 210 to 216 at: http://appropriations.house.gov/pdf/Ag_Conf_Rpt_FY2010.pdf.

FY 10 Appropriations for the Food and Drug Administration

Compared to Earlier Years (based on Conference Agreement)

Budget Authority Appropriations (does not include user fees)

(Prepared by the Alliance for a Stronger FDA)

* The $7 million increase is intended to pay for some of the additional costs that CDER will bear as a result of Conference report language that contains increased financial commitments to the Critical Path program, generic drug reviews and other CDER programs.

This entry was posted on Tuesday, October 6th, 2009 at 8:24 pm and is filed under FDA and Congress, FDA Appropriations, FDA Leadership. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.