FDA FY 2008 Budget Summary

Total Budget:  For FY 2008, FDA requests a total budget of $2.1 billion.  This amount is $105.8 million more than the FY 2007 request and represents a 5.3% increase.

Budget Authority:  In terms of budget authority, the FY 2008 budget contains a net increase of $95.3 million for high priority initiatives.  This amount is a 6.2% increase.

User Fees:  Finally, FDA’s budget proposes an increase of $10.5 million for user fees.  The $10.5 million includes inflation increases required by law for six FDA user fee programs.  This amount also includes funds a new user fee program for generic drugs.  As we did in FY 2007, FDA is also proposing two new user fee programs.  These user fee programs pay the cost to reinspect facilities that FDA regulates and to recover the cost of issuing export certificates for food and animal feeds.

Specifics on FY 2007 Initiatives:  Our FY 2008 budget advances FDA’s core mission:  promoting and protecting public health.  The budget funds initiatives in priority areas:

• $21.8M to fund pay inflation for FDA’s world-class workforce
• $10.6M to strengthen food safety
• $11.2M to modernize drug safety
• $  7.2M to improve medical device safety and device application review
• $21.3M to conducting more – and more timely – generic drug reviews; this amount includes a $5.6M increase in budget authority and $15.7M in user fees
• $27.0M to establish reinspection user fees and export certificate user fees
• $42.9M to continue to relocate FDA operations to our White Oak Campus and to pay the cost of essential infrastructure to support public health programs

Strengthening Food Safety 
+$10,664,000, + 15 FTE

More than 250 different foodborne illnesses are food safety threats.  Based on CDC estimates, 76 million Americans become sick, more than 300,000 are hospitalized, and 5,000 die each year from foodborne illnesses.  Recent outbreaks highlight the need for increased resources to strengthen food safety and enhance FDA’s ability to reduce and respond to foodborne outbreaks.

If FDA does not receive funding for this initiative, FDA will make limited progress on preventing and reducing foodborne illness.  FDA will also have difficulty maintaining public confidence in the safety of fresh produce.

What activities will these funds support?

The Strengthening Food Safety Initiative funds four FDA components:  the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Regulatory Affairs (ORA), the National Center for Toxicological Research (NCTR), and Office of Crisis Management (OCM).  These entities deliver FDA’s food safety and foodborne illness response.

CFSAN +$4,000,000

• better methods to rapidly detect and attribute foodborne illness outbreaks
• quicker intervention to reduce illnesses and deaths from contaminated food
• faster and more thorough traceback (tracking contamination to its source)
• training for state and local agencies on analyzing food safety data
• hiring microbiologists to improve the safety fresh produce

ORA +$5,500,000

• improve FDA’s capacity to determine the root cause of an outbreak
• equip and strategically position traceback teams in produce-growing regions
• training and equipment for state offices that respond to produce-related outbreaks
• deploy an IT decision system to detect high risk imports of FDA-regulated products           

NCTR +$500,000 & OCM +$644,000

• new methods to detect foodborne pathogens, select agents, and toxins 
• geographic information system mapping for faster emergency response

Modernizing Drug Safety
+$11,200,000, 25 FTE

The Modernizing Drug Safety Initiative will revolutionize FDA’s ability to identify drug safety issues.  With these resources, FDA can more rapidly identify and communicate drug safety concerns to professionals, patients, and the public. 

Goals of the Modernizing Drug Safety Initiative:

• FDA will strengthen the science and the tools that support drug safety at all stages of the drug life-cycle, from premarket testing through postmarket surveillance and risk management.
• FDA will improve communication and information flow among all stakeholders involved in the safe use of drugs.