FY 05 Omnibus Appropriations Bill

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On December 8, 2004, President George W. Bush signed the Fiscal Year 2005 Consolidated Appropriation Act (P.L. 108-447 -- Read Bill Text). The spending package, which contains funding for the Departments of Energy, Commerce, Justice, State, Health and Human Services, HUD, Interior, Labor, Transportation, and the VA, complies with the spending targets agreed to by the Congress and the Administration, totaling $821.9 billion in FY 05 discretionary spending. This represents a freeze, or zero percent growth in non-defense discretionary spending.

All additional spending is paid for by an across-the-board cut of .83% in all non-defense and non-homeland security spending, $300 million rescission in non-war, non-emergency defense funds, and $283 million from limitations on expenditures from the Crime Victims Fund. The bill drops provisions relating to overtime regulations and the Administration's competitive sourcing initiative.

Food & Drug Administration

The Food & Drug Administration (FDA) ensures the safety of the nation's foods, medicines, medical devices and other products through regulations, premarket product and manufacturer reviews, and postmarket inspections.

Highlights

• The FDA is funded at $1.462 billion, $76 million above last year and $33 million below the President's request. This includes the full amount requested for the medical device program.
• The bill meets the PDUFA trigger, making available $284,394,000 in prescription drug user fees.
• The bill provides $15.628 million for relocation expenses related to the CDER move to White Oak, Maryland. An estimated 1,700 CDER personnel are scheduled to move to the facility in April 2005.
• The bill provides an additional $300,000 for flu vaccine-related activities at CBER and the Office of Regulatory Affairs.
• CDER is funded at $498.6 million, a $20 million increase from FY 04.
• CBER is funded at $172.7 million, a $3.3 million increase from FY 04.
• The Manager's Statement:
• urges full cooperation from the FDA on all drug safety-related matters
• states the importance of establishing a private sector partnership regarding human drug compounding
• commends the FDA for its work on Alpha-1 Antitrypsin Deficiency.

Department of Health & Human Services

The Department of Health and Human Services (HHS) is the nation's largest health insurer. The department is charged with promoting and protecting the health and well-being of all Americans, and it provides world leadership in biomedical and public health sciences.

Highlights

• The NIH is funded at $28.6 billion, $800 million more than last year.
• The bill provides $2.1 billion for the Ryan White AIDS program, an increase of $45 million over FY 04. $794 million is specifically designated for ADAP.
• The CDC is funded at $4.5 billion, $167 million above last year and $320 million above the President's request.
• The bill provides $100 million for the development and purchase of flu vaccines.
• The Manager's Statement :
• expresses concerns that phase-in of Medicare Part D may result in significant out-of-pocket costs to Medicare enrollees with HIV/AIDS who now rely on Medicare and ADAP for their prescription medications
• notes the changes being developed by CMS to alter the Medicare coverage policy for power mobility devices, and urges CMS to develop a coverage policy firmly based on a functional standard of "nonambulatory".
• encourages CMS to exclude blood clotting factors from the definition of "competitively biddable drugs and biologicals"

U.S. Patent & Trademark Office

The Omnibus bill includes a major increase in patent fees, despite strong objections by the patent user community. While fees for many technology areas will increase by an average of 15 to 25 percent, biotechnology patent applications may face as much as a 30 to 40 percent increase in their fees. The significant difference in the fees in the biotechnology community is due to the PTO's discretionary practice of dividing a single biotech discovery into multiple inventions.

The fee schedule is also restructured significantly -- adding fees for excess pages of specification, sharply increasing fees for excess claims, and providing separate fees for filing, searching, and examining patent applications. All those fees will be payable upon filing.

Highlights

• H.R. 4818 raises 2005 USPTO appropriations to about $1.5 billion from about $1.2 billion in 2004.
• The fee increase will produce about $200 million a year in additional revenue for the USPTO through 2006, but there is no guarantee that the excess revenue will remain at the USPTO.
• Fees will revert to their previous levels on September 30, 2006, unless additional legislation is passed.

Agriculture

The omnibus bill provides $16.96 billion in discretionary funding and $66.294 billion in mandatory funding for USDA, approximately $123 million over the fiscal 2004 level.

Highlights

• $9.5 million is included for the Animal and Plant Health Inspection Services' (APHIS) Biotechnology Regulatory Services. The original House bill included $10.5 million, while the Senate bill only provided $5.4 million.
• The bill provides $33 million for APHIS for a National Animal Identification program, although no funds can be implemented prior to notification to the Committees on Appropriations.
• $1.299 billion is provided for the Agricultural Research Service.

For more information, please contact Susie Ahn, manager for Federal Government Relations, at (202) 962-9200 or sahn@bio.org.

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