TRENDS & PERSPECTIVES
In August, Medco Health Solutions (Franklin Lakes, NJ) and FDA announced that they had formed a partnership to examine the ways in which genetic testing might affect the efficacy of prescription medications in the future.
Medco is a pharmacy benefits manager that provides pharmacy benefit management services for nearly one in five Americans, with clients that include private insurance companies, managed-care organizations, state and local government agencies, and third-party benefit plan administrators. The company has more than 20,000 employees and had net revenues in 2007 of $44.5 billion. Medco and FDA say the partnership is planned to last until late August 2010.
According to Robert Epstein, MD, Medco’s senior vice president of medical & analytical affairs and chief medical officer, the goal of the collaboration is to help FDA identify “barriers and obstacles to the use of pharmacogenomic tests” and “new opportunities for the use of these tests.”
To do so, Medco will deliver a series of reports to FDA. The reports will focus on physician participation in pharmacogenomics testing and examine the level to which tests are useful in prescribing and how to quantify prescription information for drugs with genetic information on the label and the safety of prescription drugs.
“Leveraging our robust database of actual prescription medication use and adverse events, Medco will deliver a series of reports to FDA regarding the use and safety of particular medications or classes of medications,” Epstein said. “We’ll also provide information about physician participation in pharmacogenomic testing and the usefulness of such tests in prescribing. FDA will provide its expertise into the clinical question from a benefit and risk perspective.”
Currently, Medco is working on an ongoing genetic testing project with the Mayo Clinic and is close to completing enrollment for a study on Coumadin. At the same time, the company is working with LabCorp on a tamoxifen study. Epstein says Medco will likely publish the results of both projects in 2009.
Lawrence J. Lesko, PhD, director of FDA’s Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research (CDER), says there will be a steering committee headed by himself and Silvana Borges, MD, medical officer in the genomics group at CDER, along with representatives from the Office of Surveillance and Epidemiology, the Office of New Drugs, and the Office of Biostatistics, with additional members from the genomics group and the immediate office of the OCP.
Although FDA has formed multiple collaboration agreements in the past, according to a contractual agreement between the two organizations, this particular endeavor will involve only Medco and FDA. However, when it makes sense to do so, Medco will leverage existing relationships with institutions such as the Mayo Clinic and LabCorp.
Together, the two will develop research projects, programs, and strategies in pharmacogenomics and will examine whether physicians will use the results of gene testing to change medication dosages.
Lesko noted that FDA chose Medco following a public announcement for proposals for the company’s “excellent database on prescription drug use and outcomes data.”
According to Epstein, Medco will determine the first projects this fall. “Initially, we’ll be looking at drugs like Coumadin and tamoxifen, and any new tests that may come to market during the course of our collaboration,” he said.
“FDA expects to use the data from this collaboration in the same way it uses any postmarketing surveillance data,” FDA representatives said in a written statement. “This research is targeted specifically to genomic opportunities to improve the ways drugs are used. These data could potentially be used to relabel drugs or to add more-specific information on genomics to drug labels previously updated. These data will not result in making go/no-go decisions for investigational drugs or for regulatory decisions on new drug applications.”
However, although the organizations only recently announced the collaboration, it is clear that work is under way. In the August 2008 issue of Pharmacotherapy, Epstein and Lesko, along with several other Medco and FDA employees, published a paper titled, “Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use.”
The goal of that paper was, “To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling.” In doing so, the authors found that almost 25% of all outpatients receive at least one medication that has pharmacogenetic information in the medication label and concluded, “The incorporation and appropriate use of pharmacogenomic information in drug labels should be tested for its ability to improve drug use and safety in the United States.”
Lesko says that FDA will examine genetic diagnostic tests and physician attitudes and behaviors toward them.
