Understanding the FY13 Full-Year Continuing Resolution Bill

Both the Senate and House have passed the FY13 Full-Year Continuing Resolution bill and it has been sent to the President for signature. It is a complex document, with a number of additions and subtractions that affect FDA and render the calculation of final numbers confusing. The final legislation includes a $24 million increase in FDA budget authority (BA) (taxpayer) appropriations plus a $50 million supplemental “no year” (can be spent at any time) appropriation. This represents about a 3% increase in FDA’s BA funding over FY 12.

However, these increases (which were better than virtually any agriculture program and rare among any domestic discretionary program) are offset by a 2.513% rescission applied within the bill. After the reductions from the rescission are taken into account, the FDA is given a slight increase of about $9 million. While this increase is fairly modest, FDA did much better than most agencies, many of whom have received cuts.Further, the agency is still subject to the sequester reductions. The chart in the document entitled "Final FY13 Appropriations Numbers" explains the impact of the sequester.Also on the plus side, the legislation permits FDA to:

• Spend the higher user fee levels in FDASIA (+$18M for PDUFA and +$40M for MDUFDA),

• Fully implement the new generic user fee program (+$300M), and

• Collect and spend the new biosimilars user fees (+$20M).

However, contrary to rumor, the legislation does not affect the 5% sequester that is being applied to all non-defense discretionary spending. User fees are still included in the sequester.A more complete description of the legislation and a chart with details are also made available.