FDA Issues Final Guidance on Pharmacogenomics Submissions

The FDA is encouraging drugmakers to voluntarily submit pharmacogenomic data as part of an initiative to speed the development of personalized therapies based on patients' genetic profiles, according to a new final guidance.

The promise of pharmacogenomics lies in its potential to individualize therapies with the intent of maximizing effectiveness and minimizing risks, the FDA says in its final "Guidance for Industry: Pharmacogenomic Data Submissions."

The field of pharmacogenomics, however, is still in the early developmental stages, the guidance notes. Drug and biologic sponsors have been reluctant to embark on programs of pharmacogenomic testing during FDA-regulated phases of drug development because of uncertainties in how the data will be used by FDA in the drug application review process.

The intent of the guidance, according to the FDA, is to facilitate the use of pharmacogenomic tests during drug development and "encourage open and public sharing of data and information on pharmacogenomic test results." The guidance describes the data that will be needed during the marketing application review process, the format for submissions and the data that will be used during regulatory decisionmaking.

The FDA will hold a public meeting on the topic April 11-13. For more information, go to http://www.fda.gov/cder/genomics/default.htm (http://www.fda.gov/cder/genomics/default.htm).