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U.S. Department of Health and Human Services

About FDA

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Improving Drug Safety

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Why is this initiative necessary?

This initiative will enable FDA to continue to transform the healthcare system by reducing occurrences of drug side effects.  Drug safety problems cause more than 2.1 million injuries and 100,000 deaths per year.  The estimated annual costs of drug-related morbidity and mortality are as high as $76 billion. 

Funding this initiative will allow FDA to modernize the Adverse Event Reporting System (AERS) and establish "AERS II" as the primary source for drug product adverse event data.  The initiative will also allow FDA to enhance AERS data through further integration efforts with the Centers for Medicare and Medicaid Services (CMS). This will give FDA valuable drug safety information housed in CMS population-based databases.  This collaboration with CMS will be known as the Sentinel System.

The Sentinel System will create a seamless platform for gathering and evaluating information about adverse events related to the use of medical products.  This will enable FDA to gather more information from the point of care about potential safety problems.  It will provide a framework for turning this raw data into useful knowledge about the safe use of products so that consumers and healthcare providers have the most accurate and up-to-date information to guide their decisions.  CMS, through its role in handling large volumes of information about the use of medical products, particularly drugs as part of the new Part D drug benefit, offers an increasingly powerful repository of information about drug use.  This information will feed into the Sentinel System and FDA will use it to turn observations into greater understanding about drug safety.

Drug Safety Investments
  FY 2005
FY 2006
FY 2007 Increase
Center $17,000,000 $25,700,000 $29,264,000 +$3,564,000
Other Activities (OC)     $396,000 +$396,000

User Fees (PDUFA)

$7,600,000 $8,800,000 $9,540,000 +$740,000
Total $24,600,000 $34,500,000 $39,200,000 +$4,700,000

*These amounts do not include field resources.  For example, the amounts do not include field resources devoted to pre-market drug safety (e.g., clinical investigator and human subject protection inspections) or post-market drug safety (e.g., good manufacturing practices and adverse event inspections).  In general, more than half of the staff resources in the FDA drug program are devoted to drug safety activities.


How does this initiative support Executive Branch public health priorities?

Improving FDA's ability to access, analyze, and disseminate drug safety information will contribute to the President's vision of a "healthier and more hopeful America", by reducing the number of preventable injuries and deaths caused by adverse drug reactions. This will ensure that Americans continue to have confidence in the safety and quality of the products available to them.


What are the risks of not proceeding with the initiative?

Not funding this initiative will:

  • Limit access to vital drug safety information that holds the potential to reduce negative health affects experienced by consumers.
  • Compromise FDA's ability to efficiently and effectively identify, investigate, and notify consumers of possible drug safety concerns.
  • Impair consumer confidence in FDA and the U.S. drug safety system.
  • Allow preventable injuries and deaths due to adverse drug reactions to continue unabated.


What activities will these funds support?

Clinical trials that lead to product approvals only begin to quantify the safety and efficacy of a pharmaceutical compound or biological product.  FDA must collect and analyze data throughout the entire life cycle of the product in order to identify adverse events or "side effects" that could not have been predicted during clinical trials.

FDA requests additional funds to continue to modernize its AERS system and create "AERS II" — a replacement web-accessible computer system that will enable FDA to maintain the current level of AERS functionality, while providing enhancements in several areas.  These enhancements include adding capabilities planned in the original AERS, but not developed due to funding constraints.  With over 5 years of experience with the database, we have identified areas of critical new functionality, including generating web-accessible adverse event information.

The current AERS system is FDA's principal post-marketing monitoring tool.  It allows FDA to identify events that were not observed or recognized before approval.  It allows FDA to identify adverse events that might be happening because patients and prescribers are not using the drug as anticipated.  This current monitoring system, by itself, is not adequate for a successful, state-of-the-art drug safety program.  To appropriately monitor drug safety after marketing, it is essential that FDA have access to a wide range of clinical, pharmacy, and administrative databases, including databases maintained by:

  • The Center for Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), the Department of Defense (DoD) and the Indian Health Service (IHS).
  • Clinical and hospital networks and insurers (e.g., health maintenance organizations, preferred provider organizations, Blue Cross/Blue Shield).
  • Pharmacy benefit management organizations (e.g., Advance PCS, Premier).

FDA is actively evaluating the utility and feasibility of conducting specific studies of high priority safety issues using linked databases.  Studies conducted on these types of databases will provide more evidence about drug use in a broader range of conditions, including more detailed evidence about drug safety in subgroups of patients.  Additional resources in FY 2007 will enable us to develop robust methodologies to obtain this safety information and to validate findings by evaluating more than one data source.

These funds will also support collaboration between FDA and CMS, to access the Medicare database and conduct studies of high priority safety issues in the Medicare population.  Access to the CMS database would provide a data source rich in information on medical product use in the elderly and in patients with multiple medical conditions.


What results will FDA achieve?

FDA will:

  • Modernize adverse event reporting and better detect drug safety signals.
  • Conduct timelier and more complete drug safety review and analysis to determine the root cause of adverse events.  This will enable us to take action to minimize future errors.
  • Communicate vital safety information to health care practitioners, consumers and the research community in a more timely and user-friendly way.
  • Work with CMS on a Sentinel System and integrate CMS safety data into our safety analysis.  The CMS collaboration will provide a rich source of safety data for analysis and response.


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