United States of America - As part of an initiative to speed development of new medical products through the science of pharmacogenomics, the Food and Drug Administration (FDA) has issued a guidance document, Pharmacogenomic Data Submissions.

Pharmacogenomics allows health care providers to identify sources of an individual’s profile of drug response and predict the best possible treatment option for this individual. Until now, this technology has enabled the development of targeted therapies for metastatic breast cancer, chronic myeloid leukaemia and metastatic colorectal cancer.

Instead of the standard hit-or-miss approach to treating patients, where it can take multiple attempts to find the right drug and the right dose, doctors will be able to analyse a patient’s genetic profile and prescribe the best available drug therapy and dose from the start. Both the guidance and a new Web page are part of a broad effort under way to foster pharmacogenomics during drug development.

The guidance clarifies how pharmacogenomic data will be evaluated and describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision making. The guidance also explains a new mechanism for industry to voluntarily submit research data to further the scientific exchange of information as we move into more advanced areas of pharmacogenomic research. The voluntary data, which will be reviewed by an internal, agency-wide group and will not be used for regulatory decision making, will help FDA and industry gain valuable experience as this new field continues to evolve.

FDA’s new pharmacogenomics Web page is available at http://www.fda.gov/cder/genomics/default.htm. The Web site (“Genomics at FDA”) will include detailed information on submitting genomic data, including a decision tree to simplify data submissions, relevant regulatory information, and FDA contact information. The agency has already received several pharmacogenomic data submissions through both the regulatory and voluntary processes, and has recently approved the first laboratory test, the Amplichip Cytochrome P450 Genotyping Test®, which will enable physicians to use genetic information to select the right doses of certain medications for cardiac, psychiatric diseases and cancer.

Reference: FDA News, P05-12. 22 March 2005 http://www.fda.gov/cder/genomics/