Promoting the Safe Use of Pharmacogenetic Medicines

Considerations of beneficence and nonmaleficence direct us to the potential safety risks posed by the application of pharmacogenetics, including the reliability of safety testing based on the redesign of clinical trials, the harm that might be caused by the use of poorly validated testing, and the nonlabel and off-label use of pharmacogenetic drugs targeted at particular subpopulations. A number of measures could be adopted to address these concerns, including: the tight regulation of pharmacogenetics-based clinical development; regulatory guidelines to encourage interfirm data sharing; statutory oversight to ensure rigorous validation of new tests; better drug labeling and clinical governance measures to prevent off-label misuse; the training of doctors in pharmacoge-netics; and improved postmarketing surveillance.

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