Assumptions - All Statutory Triggers Will Be Met

Table of Contents: PDUFA III Five-Year Plan

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The law allows FDA to collect and spend PDUFA III revenues each year only if three specific conditions are met. This plan assumes that each of the three statutory conditions will be met each year:

• Total FDA appropriations each year (exclusive of user fees and rent payments to GSA) must total at least as much as FDA received in FY 1997, adjusted for inflation at the rate of change in the Consumer Price index since FY 1997. For FY 2005 and later, the chart below assumes that this will be a change of 2.5 percent each year. The assumed rates will be updated in future revisions of this plan. The estimates are as follows:
  
  

  Fiscal Year	1997 Amount ($ Millions) Less Rent and User Fees	Est. Adjustment Factor (Actual factors through FY 2004, estimated for later years)	Minimum Appropriation ($ Millions)	Actual Appropriation ($ Millions) Less Rent and Fees
  2003	$820	1.1224	$920	$1,275
  2004	$820	1.1473	$941
  2005	$820	1.1760	$964
  2006	$820	1.2054	$988
  2007	$820	1.2355	$1,013

  
  
  FDA meets this trigger consistently, even though for most years since FY 1997 FDA did not receive increases to cover the cost of pay increases and inflation for its core programs-which was the original intent of this trigger. FDA meets this trigger primarily because FDA has received appropriation increases earmarked for specific initiatives since FY 1997 (e.g., food safety, tobacco, counter-terrorism).
• Each year FDA must actually spend at least as much from appropriations on the human drug review process as it spent from appropriations on this process in FY 1997, adjusted for inflation at the rate of change in the Consumer Price index since FY 1997. For FY 2005 and later, the chart below assumes that this will be a change of 2.5 percent each year. The assumed rates will be updated in future revisions of this plan. The estimates are in the table below:
  
  

  Fiscal Year	1997 Amount Spent on Drug Review from Appropriations ($ Millions)	Adjustment Factor (Actual factors through FY 2004, estimated for later years)	Minimum Drug Review Spending from Appropriations ($ Millions)	Actual Drug Review Spending from Appropriations ($ Millions)
  2003	$148	1.1224	$166
  2004	$148	1.1473	$170
  2005	$148	1.1760	$174
  2006	$148	1.2054	$178
  2007	$148	1.2355	$183

  
  
  If FDA spending from appropriations on the drug review process is less than 5 percent of the specified minimum above, no fees may legally be collected or spent for the year. FDA will not know exactly how much it has spent from appropriations until after the end of the year when final accounting reports are prepared. FDA plans to spend this minimum from appropriations each year. In years when FDA programs do not receive appropriations to cover costs of inflation and mandatory pay increases, core FDA programs other than drug review may have to be further reduced to assure that appropriated spending for drug review meets the requirements of this trigger.
• PDUFA fee revenues may be collected and spent only to the extent provided each year in FDA's appropriation. If collections exceed appropriations, the surplus can be kept by FDA and used to reduce anticipated collections in a future year.
  
  

  Fiscal Year	PDUFA Fees Provided in Appropriations ($ Millions)1	PDUFA Fees Actually Collected ($ Millions) as of 9/30/2002	Overage, if Any ($ Millions)
  2003	$222.9
  2004
  2005
  2006
  2007

  ¹Actual amount shown for 2003. In updates of the plan, amounts appropriated in subsequent years and amounts actually collected each year will be added to this table.

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