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FDA ENHANCES ITS ABILITY TO MONITOR MARKETED MEDICINES

The Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) today announced that it has awarded contracts that give the agency access to commercial databases that contain non-patient-identifiable information on the actual use of marketed prescription drugs in adults and children.

The information contained in these large databases will significantly augment the FDA’s ability to determine the public health significance of the reports it receives through its Adverse Event Reporting System (AERS), published information, and other data sources.

The recipients of the contracts are AdvancePCS, Premier Inc., and Child Health Corporation of America.

The AdvancePCS database will allow FDA to examine how long non-hospitalized patients stay on prescription medication therapy and to learn which combinations of medications are being prescribed to patients. The contract awarded to Premier Inc. will provide similar information on hospitalized patients.

The Child Health Corporation of America (CHCA) database contains information on the use of prescription drugs in hospitalized children. This information will, among other benefits, support the ongoing initiative at FDA to have more prescription drugs approved for use in children.

These contracts represent another important advance in FDA’s continuing work to improve the management of risks associated with marketed medications.

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