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FDA Works to Speed the Advent of New, More Effective Personalized Medicines

As part of an agency-wide initiative to speed development of new medical products through the science of pharmacogenomics, the Food and Drug Administration (FDA) today issued a final guidance titled "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. For example, genomic tests are helping to identify cancers that have a good chance of responding to a particular medication or regimen. This technology has enabled the development of targeted therapies like Herceptin for metastatic breast cancer, Gleevec for chronic myeloid leukemia and Erbitux for metastatic colorectal cancer.

"FDA's efforts will bring us one step closer to 'personalizing' medical treatment," explained Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA. "This new technology will allow medicines to be uniquely crafted to maximize their therapeutic benefits and minimize their potential risks for each patient."

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 eventually be able to analyze 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 underway at FDA to foster pharmacogenomics during drug development.

FDA also 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.

"We hope ultimately to bring pharmacogenomics, a way in which to foster the personalizing of medicine, to every healthcare professional's prescription pad for the benefit of their patients and U.S. consumers," said Dr. Woodcock.

The guidance "Pharmacogenomic Data Submissions," clarifies how pharmacogenomic data will be evaluated. 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 FDA and industry gain valuable experience as this new field continues to evolve.

FDA believes this approach will save time and resources and eliminate possible delays in the application review process because parties will be able to familiarize themselves with novel pharmacogenomic approaches as they 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 be useful to industry because it includes detailed information on submitting genomic data, including a decision tree to simplify data submissions, relevant regulatory information, and FDA contact information.

FDA has already received several pharmacogenomic data submissions through both the regulatory and voluntary processes and will continue to work closely with industry and the healthcare community on this exciting emerging technology.

In addition to announcing the availability of its final guidance and the new pharmacogenomic Web page, the agency also reminded the public of the April 11 to 13 meeting being held at the Mariott Hotel in Bethesda , MD on pharmacogenomics issues. The meeting is being sponsored jointly by FDA and the Drug Information Association. The joint FDA/DIA meeting, "Pharmacogenomics in Drug Development and Regulatory Decision Making" will focus on integrating pharmacogenomics in clinical trials for new drugs, biologics, and associated devices. FDA will also address ways to translate pharmacogenomics into medical product development and clinical practice.

On April 26th at 1:00 p.m. at the Washington Convention Center , the FDA will be presenting a symposium for the public entitled "Personalizing your Healthcare: The Best Consumer is an Educated Consumer." This free session will allow members of the general public the opportunity to hear about the science behind personalized medicine, an issue of critical importance to both consumers and FDA. Presentations will be from experts in the field and there will be time for questions. For more information, please go to: http://www.fda.gov/scienceforum; for public session: http://www.cfsan.fda.gov/~frf/forum05/pubsci.html.