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The Friday Update — October 23, 2009

November 27, 2009

UPCOMING MEETINGS

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 Director of FDA Center for Veterinarian Medicine Bernadette Dunham: October 28.

RECENT MEETINGS

  • Meeting with HHS Secretary Sebelius:  Monday, October 19. (Please see below for more details on the meeting).

THE GROSSMAN ANALYSIS

On Monday of this week, the Alliance met with Secretary of Health and Human Services Kathleen Sebelius and some of her top staff.  This was a “get-acquainted” meeting at which we were also given an opportunity to explain our views on FDA and its resource needs. We received a very positive response. The Secretary is fully aware that FDA is underfunded. She recognizes that far more is expected of FDA than it has resources to accomplish. We delivered the message that: even with a 50% increase in appropriations in 3 years, FDA still needs substantial increases to offset years of neglect.

We will be following up with members of her staff who were at the meeting. Our goal is to lay the groundwork for FDA receiving another hefty increase, which it badly needs. This will require HHS to decide on positive numbers for FDA., then fight for it when/if OMB wants to cut. We have the good arguments and data. We have something to offer that is just as important: the strong, united support of a broad range of FDA stakeholders.

Our visit was timely because the next set of critical FY 11 budget decisions will be made at HHS.

By way of background, here is a description of the process:

The appropriations cycle is a year-round activity. The visible Hill process goes from the release of the President’s budget in early February until final passage, hopefully on or before October 1. During October, November and December, appropriations staff work on program oversight, field hearings, research, meetings with the agency and preparation for the next fiscal year.

While  the FDA is spending FY 09 money and waiting for Congress to decide upon FY 10 monies, the planning cycle for FY 11 appropriations is already underway. Every unit at FDA prepares their requests for their staffing and budget for the fiscal year starting 15 months later (FY11). These requests are eventually consolidated at the Center level. Since requests usually exceed what is possible, there is prioritizing and economizing that takes place.

Subsequently, this process is repeated again with Centers submitting staff and budget requests to the Commissioner’s office. Once FDA has its all-agency request ready, it is submitted to the Secretary’s office. There it is consolidated, prioritized and pruned as part of a process by which the Secretary determines the total HHS request for each of its operating divisions (NIH, CMS, CDC, etc.).

A similar process is repeated at the Office of Management and Budget (OMB), creating the President’s request for FY 11. HHS and other departments will get a proposed final number from OMB around Thanksgiving time. They will have part of December to formulate and negotiate for items/programs that OMB has proposed to cut from the department’s request. Then the President talks about the budget in his State of the Union speech and details are delivered to the Congress about 10 days later, usually in the first week of February.

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

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