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FDA issues pharmacogenomics data submission guidance

The US Food and Drug Administration (FDA) has issued a final guidance entitled ‘Pharmacogenomic Data Submissions.’ With several major drugs failing during the past year, the guidance is seen as an opportunity for companies to apply their related technologies and vindicate the use of pharmacogenomics in improving the drug discovery process. The FDA guidance provides information on the correct format for pharmacogenomic data, standard operating procedures that indicate how a company should go about submitting voluntary pharmacogenomic data, and how the voluntary data will be reviewed by a specially created group within the FDA, known as the Interdisciplinary Pharmacogenomics Review Group. “This guidance is important because it is the first major guidance on the use of pharmacogenetics and the regulatory interaction,” said Chris Webster, Director of Regulatory Strategy and Intelligence, Millennium Pharmaceuticals, Inc. “It also creates a new paradigm for the industry to interact with regulators in terms of voluntary data submissions, the idea being that we can voluntarily submit soft, exploratory data for consideration by the authorities and they will not use it for decision-making, which is something unheard of until now. That paradigm can, and we hope will, be applied to other areas as well, such as biomarkers.” Millennium made a voluntary pharmacogenomic data submission last year for the drug bortezomib, which is being codeveloped with Johnson & Johnson Pharmaceutical Research & Development, and is approved for the treatment of multiple myeloma patients who still show disease progression after treatment with other therapies. The company included the soft data in the original regulatory application and the FDA asked if they would submit the data voluntarily in Phase IV. Lawrence Lesko, Director, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, FDA, remarked that genomics technology has evolved very rapidly, spawning a large number biomarkers, and the guidance classifies those biomarkers as exploratory, probable valid and known valid biomarkers. “The importance of clarifying biomarkers is that they lead one to understand how these biomarkers will subsequently be used in decision-making within drug development and decision-making within the FDA.” Dennis Gilbert, Chief Scientific Officer of Applied Biosystems, said the introduction of standards and data analysis requirements helps demonstrate how the various technology platforms will need to comply to meet those guidelines. “For microarray data, for example,” he said, “having guidelines on how to set up the experiment, how to analyze the data and how many controls are needed, will help add a level of validation and rigor required to support clinical application.” He noted that the guidance focuses on genomic technologies, and does not include proteomic or metabolomic data, due to the developing nature of these technologies.