The Senate is under threat of  “no days off” until healthcare reform legislation passes.

ADVOCACY

Metrics Project. We are working to identify dates to hold the next Drugs/Biologics, Food, and Device Metrics Sub-Group calls sometime in December.  Dates and times for each Sub-Group call will be provided in the near future.

THE GROSSMAN ANALYSIS

Tradition says that 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. The Senate is under threat of  “no days off” until healthcare reform legislation passes. The Executive Branch is working full-tilt to complete work on the President’s Budget Request for FY 11. The President has  chaired a day-long meeting on how to create new jobs in the American economy. Then there is Afghanistan, Iran, Iraq, financial reform, tax issues and global warming. We can only hope some people will get their anticipated vacation and family time.For the Alliance for a Stronger FDA, the critical December event is the President’s Budget Request. It will be mentioned a number of times in the State of the Union address. Then the details will be released about a week later by the Office of Management and Budget (OMB).  Given the long-lead time for final adjustments, compilation, and publication, the key decisions are being made now and over the next few weeks.The week after Thanksgiving is when OMB gives each federal department it’s “passback number,” the amount allocating to each agency and function for the following year’s budget request. Secretary Sebelius has received the DHHS passback and will need to decide on a few priority items to appeal. This will go to OMB for consideration. Final decisions are likely to be made before Christmas.In prior columns, I have discussed how the President’s FY 11 budget request is likely to be deeply constrained. Having successfully advocated for a number of expensive initiatives, President Obama will need to show that he can also reduce the deficit. He asked Cabinet secretaries to submit their budget requests on the assumption that their Department will not grow next year and may be reduced by 5% overall. With mid-term Congressional elections less than a year away, Congress will also be feeling pressure to reduce government spending.It is likely that  much of the government will be flat-funded in the President’s budget. Agencies are being hit hard, regardless of merit. For our special cause—strengthening FDA through increased appropriations -- it is critical that HHS, OMB and White House know how important FDA funding is. The time to engage them is now.

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

MEDIA/NEWS

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The Alliance for a Stronger FDA has recommended that FDA receive a $500M increase for FY 2011.