FDA Partnering With Medco To Study Genetics, Rx Treatments
FDA and pharmacy benefit manager Medco Health Solutions are collaborating on a two-year, pharmacogenomics-based study that will examine the relationship of patients' genetic composition with the medications they are prescribed, the Wall Street Journal reports.
According to the Journal, the study seeks to expand the PBM's previous scientific research on the benefits of "personalized medicine," which advocates say can help physicians choose the best treatments to avoid or reduce the likelihood of a harmful reaction, eliminate ineffective treatments and offer the best outcome to patients.
Medco, as part of the collaboration, will submit reports to FDA on the tests, the participating physicians and efficacy of using genetic test results in prescribing medications. Medco said that its reports also will include information on whether physicians are open to modifying a drug dosage based on findings of a patient's genetic test.
Company officials said that most of the information will be derived from its pharmacy claims database and that information that could reveal patient identities will be kept private.
Robert Epstein, Medco's chief medical officer, said there currently are about 24 pharmacogenomic tests available to consumers that provide compatibility tests for certain kinds of medications, but they do not provide genetic tests for specific disease risk factors and genetic predisposition for diseases.
An FDA spokesperson said, "We expect that the information FDA will obtain from the study will identify future opportunities to better understand the risk of medicines and ways to improve drug dosing" (Wisenberg Brin, Wall Street Journal, 8/19).