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The Friday Update — October 9, 2009

November 27, 2009


Principal Deputy Commissioner Joshua Sharfstein to Address Alliance Members/Notice of Annual Member Meeting Change to Thursday, October 29.

Dr. Sharfstein will address Alliance Membership at 2:00 pm and the Annual Member Meeting will take place immediately following Dr. Sharfstein’s remarks.  Location:  1333 New Hampshire Avenue, NW, 10th Floor.

Please note that the Alliance Annual Member Meeting which was initially scheduled for October 27th has been changed to the 29th to coincide with Dr. Sharfstein’s address to Alliance Membership.

Other Meetings:

  • Meeting with HHS Secretary Sebelius:  Monday, October 19 at 11:00 AM
  • Meeting with FDA Director of Office of Regulatory (ORA) Affairs Mike Chappell: Tuesday, October 13, at 10:00 AM
  • Meeting with FDA Director of National Center for Toxicological Research Dr. Slikker: Wednesday, October 14 at 2:00 PM
  • Meeting with Director of FDA Center for Veterinarian Medicine Bernadette Dunham: October 28, 2009 at 11:00 AM


The Alliance has been focused on FY 11, even as FY 10 was being completed. It is valuable to see how far we have come with the  FY 10 Ag/FDA appropriations.

The conference report is available on line. The section on FDA is at pages 210 to 216 of the PDF.  Also, we have attached a table that compares the FY 10 final to the President’s request and to FY 09 and 08. Here are some highlights:

  • FDA received $306 million (15%) more to spend this fiscal year. Every center will have more resources to work with.
  • The final conference agreement is $7 million more than the President’s request. The increase is intended to offset some of CDER’s costs for conference report language that increases allocations to the Critical Path and generic drug reviews.
  • By far, CFSAN received the largest increase in FY 10: $134M. Since FY 08, food has grown by more than 50%. Much of the increase has been for field activities (inspections and enforcement).
  • CDER received the next largest increase in FY 10: $52M.
  • CDRH received a $35M increase in FY 10.
  • CDER, CBER and CDRH have all grown by more than 30% since FY 08.

Here is the big picture:

  • The overall agency has grown by $631M since FY 08 (2 fiscal years).
  • The overall agency has grown by $776M since FY 07 (3 fiscal years), more than a 50%  increase in its base appropriations.
  • FDA also received a one-time $150M supplemental appropriation in FY 08, making the total of new funds more than $900 million in 3 fiscal years.

These are the hard numbers. Prior to FY 08, FDA couldn’t even count on a $75 million annual increase. FDA has gotten a decade’s progress in 3 fiscal years and the trajectory of FDA funding has been completely altered.

Every Alliance member should pat themselves on the back for being part of this change. We have truly helped create a stronger FDA.

Now we need to go back to work. Our job is not done. FDA was severely underfunded for so long, that no one really knows how much it will take. Plus, the world grows more complex every day, as does science. New responsibilities are constantly being added; old responsibilities are being re-interpreted.

With new funding comes higher expectations. FDA needs us now, more than ever.

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


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