The FDA yesterday issued its Guidance for Industry on Pharmacogenomic Data Submissions.
The long-awaited guidance is expected to provide a road map to drug developers to step up the science of tailoring drugs to people and ultimately improve drug safety and efficacy and help avoid withdrawals similar to Vioxx.
The relatively new science of pharmacogenomics allows healthcare providers to identify sources of an individual's profile of drug response and predict the best possible treatment option for this individual.
For example, genomic tests are helping to identify cancers that have a good chance of responding to a particular medication or regimen.
The technology has enabled the development of targeted therapies like Genentech's Herceptin for metastatic breast cancer, Novartis' Gleevec for chronic myeloid leukemia and ImClone's Erbitux for metastatic colorectal cancer.
The final guidance 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 the FDA and the pharma industry gain valuable experience as this new field continues to evolve, the FDA said in a statement.
"FDA's efforts will bring us one step closer to 'personalizing' medical treatment," said Janet Woodcock, the FDA's acting deputy commissioner for operations. "This new technology will allow medicines to be uniquely crafted to maximize their therapeutic benefits and minimize their potential risks for each patient."