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FY13 Appropriations Proposed by Senate Appropriations Committee

March 13, 2013

The Alliance for a Stronger FDA issued the following summary information about the FY13 appropriations proposed by the Senate’s full Committee on Appropriations to its members earlier today.

SENATE APPROPRIATIONS BILL: Sometime this week, the Senate will take up the Mikulski-Shelby bill that is a substitute for the House-passed FY 13 CR legislation. The portions of the bill dealing with FDA are quite positive for the agency and likely to stay in the bill that is finally passed by the Senate.  The fate of the legislation in the House is unknown and may turn, in part, on what the Senate does with a number of the amendments that are expected.

RELATIONSHIP OF THE SENATE APPROPRIATIONS BILL TO SEQUESTER: The Mikulski-Shelby bill appropriates FY 13 monies at a level that meets the Budget Control Act of 2011 required ceilings for that year. However, the stated numbers do NOT include the effect of the March 2, 2013 sequester. Rather, the legislation is subject to a sequestration order if the President fails to reach agreement with Congress on an alternative. The FDA appropriations total in the bill (BA appropriations and user fees) will be reduced by the $209 million sequester if no deal is reached.  While we still have hopes, a sequester deal must be considered unlikely.

SENATE APPROPRIATIONS BILL HIGHLY FAVORABLE TO FDA  (please see relevant bill text and report):

  • Virtually identical to the FY 13 bill passed by the Senate appropriation committee last April, except that the individuals centers received slightly more than the prior Senate bill.
  • All of the changes subsequently adopted in FDASIA have been included (two new user fees plus higher cap levels for PDUFA and MDUFA).
  • Consistent with the Senate bill, FDA’s budget authority appropriation for FY 13 will be increased by $24 million in FY 13 over FY 12 (not considering the impact of the sequester). See the chart below, as well as the description of how the increase is allocated and how it is a combination of new monies and internal FDA savings.
  • In addition to the larger regular appropriation for FDA, the Mikulski-Shelby bill includes section 719, which includes substantial new “no-year” (can be spent at any time) monies:

SEC. 719. For an additional amount for ‘‘Food and Drug Administration, Salaries and Expenses’’, $50,000,000, to remain available until expended, of which $40,000,000 is for one-time activities directly related to implementation of the Food Safety Modernization Act, and of which $10,000,000 is for one-time activities directly related to improving the safety of the human drug supply 

  • Thus, counting both the FY 13 new BA appropriations and the no-year money, FDA’s nominal increase over FY 12 is $74 million. The sequestered amounts must still be taken from total of both BA appropriation and user fees, as they existed on March 2.

FY 13 BA APPROPRIATION UNDER THE MIKULSKY-SHELBY BILL: Includes a $24 million increase in BA appropriations over FY 12, as follows:

Function
Budget authority only

FY 12
Final

FY 13 Senate Approps Comm.  Mark  4/26/12

Salaries and Expenses $   2.497 billion

$2.5245 billion

Building & Facilities Repair

$9 million

$        5.3 million

All BA appropriations
Total (no user fees)
$   2.506 billion

$2.530 billion (rounded)

        

The increase of $24 million is derived by the offset of a series of increase and decreases, as follows:

        Increases:  $47.1 million

  • $12.5 million for implementation of the Food Safety Modernization Act
  • $21.1 million for necessary expenses, mandatory rental payments, and facilities (we believe this includes funding for outfitting the new biological sciences building, but this is not confirmed)
  • $  3.5 million for advancing medical countermeasures
  • $10.0 million for safety inspections in China

        Decreases:   $23.2 million

  • $19.7 million in FDA-proposed information technology savings
  • $  3.5 million in building and facilities repair

        Net increase: $23.9 million

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