Medco, FDA Collaborate on Personalized Medicine - Drug Discovery and Development

Medco Health Solutions, Inc., the pharmacy benefit manager, and the Food and Drug Administration (FDA) have entered into a research partnership to study genetic testing and the impact of genetics on the efficacy of prescription drugs.

Under the partnership, Medco and the FDA will jointly develop research projects, programs, and strategies in the area of pharmacogenomics—aimed at improving patient health and quality in the delivery of care. Pharmacogenomics is the science of capturing a patient’s genetic information to help predict how a person is likely to respond to a wide variety of drugs, including commonly used prescriptions such as pain relievers, anticoagulants, and cancer drugs. This information has a bearing on what drug is selected and may help optimize doses for particular drugs. Commercial tests are currently available to identify the appropriateness of specific drug treatments based upon a patient’s genetic profile.

The research agreement extends to Aug. 31, 2010, during which time Medco will deliver a series of reports to the FDA about pharmacogenomic testing. The topics to be studied will address the safety of prescription drugs, physician participation in pharmacogenomics testing, the usefulness of the tests in prescribing, and quantifying prescription information about drugs that have genetic information in their labels. Medco’s reports will be derived from clinical settings, including one that will examine whether physicians are willing to change the dose of a prescription based on a genetic test result. Medco’s database of pharmacy claims will supply a large portion of the data to be used in the reports for the FDA.

Release date: August 18, 2008
Source: Medco