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The need for education in pharmacogenomics: a regulatory perspective

The Pharmacogenomics Journal volume 5, pages 218–220 (2005)Cite this article

Pharmacogenomics is changing the way drugs are being developed, approved and used. The Gurwitz et al article found in the previous issue is a timely ‘call to arms’ to ensure that this important field does not remain the wisdom of few, but becomes widely accepted and used. We are at a critical stage in pharmacogenomics: the science is not new, but has experienced a significant boost since the human genome project has been completed. Now is the time to capitalize on what basic science has provided and translate it into clinical practice. However, this can only happen if physicians and other health-care professionals, as well as patients, are being educated and become knowledgeable about pharmacogenomics.

In an earlier article,1 we have identified the players in the field. These players are the drivers without whose support pharmacogenomic research and its translation into personalized medicine will not become reality in modern medicine. Key players include patients, physicians, health-care providers (including payers, pharmacists), regulatory agencies, and industries developing and manufacturing the products, that is, the drugs, devices, and tests. While Gurwitz et al points out the necessity for public, and in particular scholarly education, this article illuminates the importance of this education with respect to the responsibilities and function of regulatory agencies.

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Authors and Affiliations

  1. US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Clinical Pharmacology and Biopharmaceutics, 1451 Rockville Pike, HFD-860, Room 2040, Rockville, 20852, MD, USA

    F W Frueh, F Goodsaid, A Rudman, S-M Huang & L J Lesko

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  1. F W Frueh
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  2. F Goodsaid
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  3. A Rudman
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  4. S-M Huang
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  5. L J Lesko
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Frueh, F., Goodsaid, F., Rudman, A. et al. The need for education in pharmacogenomics: a regulatory perspective. Pharmacogenomics J 5, 218–220 (2005). https://doi.org/10.1038/sj.tpj.6500316

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