August 18, 2008 / 7:02 PM / 9 years ago

Medco, FDA to study role of genetics in medicine

NEW YORK, Aug 18 (Reuters) - Medco Health Solutions Inc MHS.N will collaborate with the U.S. Food and Drug Administration to research the role of genetics in the safety and effectiveness of drugs, the pharmacy benefit manager said on Monday.

The two-year agreement is the latest step in the overall development of “personalized medicine,” in which treatment is tailored to a patient’s genetic makeup, carrying the promise of reducing unnecessary use of drugs.

Medco, the large U.S. manager of prescription drug benefits, will help the FDA assess obstacles to the use of existing genetic tests as they relate to the prescribing of medicines, as well as new opportunities for such tests.

“The big-picture goal is to facilitate the uptake of appropriate pharmacogenetic testing in the marketplace,” Medco Chief Medical Officer Robert Epstein said in an interview. “It can’t really happen if you don’t have good information about both the science but also the practice of medicine.”

Such use of genetic testing “should take trial and error out” of prescribing and “make people feel more confidence in the drugs they’re being placed on because they know for them personally that drug should work,” Epstein said.

Medco will deliver a series of reports to the FDA under the agreement, which runs until Aug. 31, 2010. Areas of study include the safety of prescription drugs, physician participation in pharmacogenomic testing, and the usefulness of such tests in prescribing.

Medco did not disclose financial terms of the agreement. Based in Franklin Lakes, New Jersey, it has about 60 million members and will draw upon its database of pharmacy claims for a large portion of the data in the reports.

Epstein said the first projects will likely be determined this fall and that the initial areas of study may be oncology and HIV/AIDS.

Medco seeks to lower drug spending for its clients, which include health plans and large employers, and sees pharmacogenomics as a potential way to control costs and improve quality of care.

The company has two other research collaborations involving pharmacogenomics. One, with the Mayo Clinic, is studying the use of warfarin, a difficult to use blood thinner that can cause serious bleeding in some patients.

Another Medco partnership, with Laboratory Corp of America Holdings (LH.N), is studying the use of the breast cancer treatment tamoxifen.

Medco plans on submitting some of the research stemming from the FDA partnership to peer-reviewed journals for publication. (Editing by Daniel Trotta and Brian Moss)

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