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The Rubber’s Getting Closer to the Road

February 18, 2011


  • House FY11 CR Action. We are expecting a final House vote on HR 1 sometime tonight or tomorrow.  See chart at bottom of update with Center-level impacts on FDA based on the version that went to the House floor.  Also, our analysis and commentary section below does an in-depth analysis.
  • House and Senate are out next week. The House and Senate are out for President’s Day week, returning on February 28/March 1.
  • Current FY11 CR Expires on March 4. This leaves less than a week for the Senate to respond to the House proposal before the CR expires. Many insiders are expecting at least one or two short-term CRs until a final compromise is reached  but there is also some talk about a stalemate and shutting down the government.
  • What can you do to help prevent the FDA budget from being cut?
  1. Join us on our Hill meetings. Just e-mail Tony Curry of your interest and availability.  We are focusing our meetings in the next two weeks on the Senate side.
  2. Plan to participate in 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.
  3. Help us on our messaging. We need Alliance members to tell us: what good things has FDA been able to do with increased funding over the last few years.


Topline: The House FY 11 CR would be devastating for FDA. The President’s FY 12 request for FDA keeps building FDA to meet its responsibilities. Both numbers are far from what the agency will actually receive.  And yet, where we start really makes a difference in where we are likely to wind up.

The new House has both the will and the votes to dramatically reduce federal spending. What is surprising is the size of the cuts that are planned for FY 11, despite the limited number of months left in the fiscal year. As recounted last week, FDA did okay in the first round of proposed program reductions. The agency would have been reduced by $220 million from the President’s FY 11 Request, but “only” $62 million below the FY 10 appropriated amounts. While not acceptable as a final amount, it was likely to be the worst number we would see. It left room for FDA to have some modest growth after the House and the Senate compromise on final numbers.

When the House appropriations committee was asked to find another $24 billion in FY 11 cuts, we knew this would be bad for all federal agencies, including FDA. Indeed, under HR 1, the current House FY 11 CR, FDA would receive $400 million less than the President’s request and a whopping $242 million below the FY 10 appropriation. No matter how supportive the Senate might turn out to be for FDA’s cause, the House position makes it quite unlikely that the final compromise will provide any growth to FDA. If the House and Senate were to “split the difference,” as is often the case, the second set of House numbers pulls the “middle ground” way down. This is discouragin … but be assured that the Alliance will continue to advocate for the highest possible number for FDA.

At this point, we do not know the funding impact on FDA of the House’s debate on HR 1 — because debate is still ongoing and because a clean, updated version of the legislation may not be available until next week.  The Senate will take up its FY 11 CR debate after the House and Senate return from recess on February 28. There is no indication of how the Senate will approach this task.

The President’s FY 12 request has the opposite effect of the House efforts on the FY 11 CR. By asking for an increase in appropriations of $382 million above the FY 10 base, the President has made clear that he believes FDA is an exception to budget-cutting. When the dialogue gets going on FY 12 funding, it seems likely that the President’s number will be the highest on the table. Just as the House CR will tend to drag numbers lower, there is hope that the President’s numbers will pull numbers higher. As with the debate on the FY 11 CR, where we start really can make a difference in where we are likely to wind up.

Below is a revised and updated comparison chart of the FY 10 base, the House’s position on FY 11 and the President’s request for FY 12.  The House numbers are those of the Committee bill. At this point, we do not think any floor amendments have changed FDA’s predicament, but we await a final, clean version of the legislation before we can say for sure.

UPDATED: February 15, 2011 PM


FDA Budget Authority Appropriations (does not include user fees)

(President’s FY 12 Request Compared to FY 10 and House Proposed FY 11CR)

**The House FY 11 BA numbers are derived by subtracting user fee revenue from total revenue. This table assumes that FY 11 user fee income would be allocated to individual centers and budget lines in the same amount as in the President’s FY 11 budget request.


Note: budget authority only, by center

FY 10  Final (October 2009)

FY 11 CR to 3/4/11

FY11 House CR Proposal–2/11/12  subj. to results of floor debate ** FY 12 Pres. Request—

Feb. 14, 2011

+/- for FY 12 Request over FY 10 enacted
Food $   781  million

3486 FTE

$  727 million $   955 million

3824 FTE

+$   174 million
Human Drugs $   462  million

2085 FTE

$  416 million $   498 million

2193 FTE

+$     36 million
Biologics $   206  million

858 FTE

$  184 million $   225 million

926 FTE

+$     19 million
Animal Drugs/Feed $   135  million

636 FTE

$  123 million $  148 million

682 FTE

+$     13 million
Devices & Radiological Health $   314  million

1494 FTE

$  282 million $    329 million

1553 FTE

+ $    15 million
Natl. Ctr. For Toxic. Research $     59  million

210 FTE

$    35 million $     60 million

215 FTE

+ $      1 million
HQ, Officer. of Commissioner & Other $   141  million

644 FTE

$  122 million $   198 million

742 FTE

+ $    57 million
Rent & Facilities Cost $    248 million


$  214 million $   318 million


+ $    70 million


SUBTOTAL, Salaries and Expenses $ 2.346 billion

9413 FTE

$2.104 billion

With rounding

$242M below FY 10

$400M below FY 11 Pres. Request

$2.731 billion

10,135 FTE

+ $  385 million
Building and Facilities Repair $      16 million


Number not provided $     13 million


– $     3 million
All BA appropriations

Total (no user fees)

$ 2.362 billion

9413 FTE

$2.744 billion

10,135 FTE

+ $  382 million
  • Existing user fees: PDUFA increases from $667 million to $856 million; MDUFMA increases from $62 million to $67 million; ADUFA increases from $19 million to $22 million; animal generic drugs increases from $5 million to $6 million; tobacco increases from $450 million to $477 million.
  • Newly authorized fees: $12 million for food recall; $15 million for food reinspections; $71 million from voluntary qualified import program.
  • Proposed, not authorized: $40 million from generic human drugs; $14 million for reinspections other than food; $5 million for inspection-related activities at domestic courier facilities.

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


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