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Pharmacogenomic drug development raises new challenges for drug regulatory agencies

In the future, instead of making an educated guess about what medication to prescribe for a patient, a doctor may use a genetic test to indicate which medication the patient would respond to best. Such tests could also be used to determine if a patient is among those who might suffer severe side effects from a certain drug. Pharmacogenomics, the study of how genetic variations affect the ways in which people respond to drugs, may make this possible.

In addition to potential future clinical benefits, such as reducing adverse drug reactions and optimizing medication efficacy, pharmacogenomic drug development poses new challenges to drug regulatory agencies, explains Amalia M. Issa, Ph.D., M.P.H., of the University of California, Los Angeles, School of Public Health. Her work is supported by the Agency for Healthcare Research and Quality (T32 HS00046).

In a recent article, Dr. Issa describes the impact of pharmacogenomic-guided drug development on the regulatory process in the United States. She also uses several hypothetical vignettes to illustrate a number of issues that might confront regulatory authorities like the U.S. Food and Drug Administration (FDA) as they begin to set policy to deal with pharmacogenomic-based drug development.

In one vignette, company A has developed a diagnostic genotyping kit. Company B has a drug that would be more clinically beneficial for a certain patient population if it were marketed in combination with company A's kit. However, company B may be concerned about the prospect of potential reductions to its market if the FDA requires the drug label to include information requiring or encouraging physicians to use the genotyping diagnostic kit that is sold by the rival commercial company.

See "The regulation of pharmacogenomic-based drugs and policy making," by Dr. Issa, in Current Topics In Medicinal Chemistry 4(13), pp. 1455-1460, 2004.

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