The U.S. Food and Drug Administration (FDA) today announced that its Center for Drug Evaluation and Research (CDER) has awarded four contracts that give the FDA access to databases that significantly strengthen the FDA's Drug Safety Program by helping the agency evaluate the safety of new drugs faster and more effectively. The contracts represent another important advance in FDA's continuing work to improve the management of risks associated with marketed medications.

In the past, FDA's collaboration with researchers who have pharmacoepidemiologic databases to investigate suspected associations between drug exposures and adverse events was through a cooperative agreement (i.e. grant) mechanism. In order to increase both accountability for and control over the funds obligated to this effort, FDA decided to change the way it gained access to these data. Effective September 23, 2005, this collaboration will occur thru a contract mechanism. The contracts will also allow FDA more flexibility and access to a wider range of data resources.

The databases contain medical claims of health care encounters and outpatient prescription drug use which can, in turn, be used to study the association of various medicines with serious adverse effects. The databases provide an additional tool that will enable the FDA to more quickly uncover rare side effects that sometimes become apparent only after drugs are approved and given to many thousands or millions of patients. The databases represent a variety of health care settings including health maintenance organizations (HMO's), preferred provider organizations, and state Medicaid programs. For some drug safety questions, collaboration between database resources will be possible, providing FDA with enhanced capacity to keep consumers better informed about the risks and benefits of the products they use so they can make the best possible decisions about their health.

The recipients of the contracts are Ingenix, Inc.; Kaiser Foundation Research Institute; The Vanderbilt University; and Harvard Pilgrim Health Care, Inc.

The following links provide information on each contract:

Ingenix Inc.
The Kaiser Foundation Research Institute
The Vanderbilt University.
Harvard Pilgrim Health Care, Inc.Harvard Pilgrim Health Care Inc.

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