Pharmacogenomics: the FDA's view
document that encourages drug and biologic developers to conduct
pharmacogenomic tests during drug development and clarifies how the
agency will evaluate the resulting data.
The US Food and Drug Administration (FDA) yesterday issued a new document that encourages drug and biologic developers to conduct pharmacogenomic tests during drug development and clarifies how the agency will evaluate the resulting data.
"Pharmacogenomics holds great promise to shed scientific light on the often risky and costly process of drug development, and to provide greater confidence about the risks and benefits of drugs in specific populations," said FDA Commissioner Mark McClellan.
Pharmacogenomics deals with the small genetic differences that help explain why some people respond positively to a drug, while others do not respond or experience a side effect. Genetic differences also can predict variations in drug metabolism. The hope is that pharmacogenomics may be used to individualise therapy by predicting which individuals have a greater chance of benefit or risk, thus helping to maximise the effectiveness and safety of drugs.
In the draft guidance, the FDA said it believes that pharmacogenomic testing can be smoothly integrated into drug development processes.
The aim is to ensure that evolving regulatory policies and study designs are based on the best science, as well as to provide public confidence in this new field where scientifically appropriate, facilitate the use of pharmacogenomic tests during drug development and clarify for industry what types of data to submit to FDA.
"Using genomic testing to guide drug therapy will constitute a significant shift from the current practice of population-based treatment towards "fine-tuning" individual therapy," commented Janet Woodcock, Director of the FDA's Centre for Drug Evaluation and Research.
Currently, scientific understanding of pharmacogenomics is most advanced in the drug metabolism area, and early results are expected in this field. However, the FDA anticipates rapid evolution of additional uses, for example to help identify cancers that have a high probability of responding to a particular medication or regimen.
The guidance provides specific criteria and recommendations on submission of pharmacogenomic data to investigational new drug applications (INDs), New Drug Applications (NDAs) and Biological License Applications (BLAs).
