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President Comments on Need for FDA Modernization

February 26, 2011


  • The House and Senate return next week after spending President’s day week working at home.  Looming large – the end of the current CR on March 4.
  • Today, the House proposed a two-week-long Continuing Resolution to begin once the current CR expires on March 4.  The House plans to take it up next week Tuesday.  While there are cuts in the proposed CR, the FDA is funded during that two week period at current levels.
  • Meetings with Senate Agriculture Appropriators:  The Alliance is meeting with the offices of Senate Agriculture Appropriators next week.
  • What can you do to help prevent the FDA budget from being cut?
  1. Plan to come to Alliance for a Stronger FDA Hill day on March 16.  It is less than a month away.  Please put it on your calendar – we need all the help we can get.
  2. Help us on our messaging.  We need alliance members to tell us: what good things has FDA been able to do with increased funding the last few years.


The short-term FY 11 CR/What happens in a shutdown?  Next week’s headlines will be about the short-term FY 11 Continuing Resolution (probably to fund government until March 18). Congress has until March 4 to pass something or the government shuts down at 12:01 a.m. on Saturday, March 5. If there is a shut-down, Congress will work all weekend and probably come up with a compromise before Federal workers are due at work on Monday morning. Rhetoric aside, no political leader wants to be responsible for telling more than a million workers to stay home.

If the government were to shut down, only essential personnel would be permitted to enter government buildings and perform work. Government-wide, as well as at FDA, a lot of government employees will be shocked (and their egos deflated) when they discover that they are not essential personnel. At FDA, there would probably be more security guards, maintenance engineers and people to keep lab animals alive, than there would be employees with clinical, regulatory or inspection responsibilities.

The other question we have been asked is whether FDA would be able to spend user fee dollars and thus maintain a decent-sized staff during a shut-down. Our best thinking is: user fees cannot be disbursed except through an appropriations bill, so these funds are not available in the absence of an appropriations bill. However, FDA is not revealing any aspect of its contingency plans, including the status of user fees. So, we have no definitive answer on user fees.

The short-term FY 11 CR/Latest maneuvering. At 5 p.m. this evening (Friday), House Republican leadership has announced their plans for the short-term CR extension. It will be taken up on the House floor Tuesday. They propose an extension to March 18, but want agreement on $4 billion in cuts/savings locked into this CR.  The package includes $1.2 billion in saving from ending programs in FY 11 that President Obama proposed for termination in FY 12. Also, they would cut $2.7 billion in earmarks. The House Appropriations Committee press release and summary is at: The CR bill text is at:

This proposal is much less (in total dollars and breadth of programs affected) than what we expected from the House as a condition of passing the short-term CR. If a government shut-down occurs, the House does not want to be seen as the unreasonable party. It is too soon for any response from Senators, but we think the House package, or something like it, will be the basis of an agreement before the March 4 deadline.

FDA is untouched by the cuts in the House proposal for the short-term CR.

The long-term FY 11 CR. While the issues surrounding the short-term FY 11 CR are being resolved, Congress will still be struggling with how to resolve the longer-term CR (presumably March 19 to September 30). The House already has a well-defined position, having adopted HR 1 with $61 billion in cuts/savings below the FY 10 funding level.  FDA is very vulnerable; it would sustain a loss of $241 million below its FY 10 spending level. This is not just a 10%, but the savings will need to be found in the remaining 6 to 7 months of FY 11, suggesting a higher level up to 20% reduction.

Unlike the House, it is hard to imagine the Senate voting on straight party lines on the long-term FY 11 CR. There are at least 65 to 70 votes (maybe more) in the Senate for serious deficit reduction (divided only by “how much?”). There is also a core of Republican and Democratic centrists who can deny either party a majority.

Media has reported that Senate Democrats are looking at $33 billion in FY 12 cutbacks and program terminations proposed by President Obama … to see if accelerating them into FY 11 is feasible. While the House has grabbed $1.2 billion of these for the short-term CR, that might still leave room for enough early program terminations to fund a bi-partisan FY 11 deficit reduction bill in the Senate. Any attempt by the Senate to build FY 11 on the President’s request for FY 12 would be good for the FDA, since the President proposed a significant increase for FDA.

As is to be expected, FDA’s fortunes look up one day, then down another. The Alliance will keep you apprised, but more importantly, we will be working with Congress to get the largest appropriations possible for FDA in FY 11 and FY 12.

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


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