As part of an agency-wide initiative to speed development of new medical products through the science of pharmacogenomics, FDA has issued a final guidance titled "Pharmacogenomic Data Submissions."

Pharmacogenomics allows healthcare providers to identify the best possible treatment option for an individual. For example, genomic tests help 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 such as Herceptin for metastatic breast cancer, Gleevec for chronic myeloid leukemia and Erbitux for metastatic colorectal cancer, the agency noted.

"FDA's efforts will bring us one step closer to personalizing medical treatment," explained Janet Woodcock, M.D., 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."

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 eventually will 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 (www.fda.gov/cder/genomics/default.htm) are part of a broad effort underway at FDA to foster pharmacogenomics during drug development.

FDA also approved the first laboratory test - the Amplichip Cytochrome P450 Genotyping Test - to enable physicians to use genetic information to select the right doses of certain medications for cardiac and 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," Woodcock said.

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.

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, Woodcock said.

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 pharmacogenomics Web page includes detailed information on submitting genomic data, including a decision tree to simplify data submissions, relevant regulatory information and FDA contact information. FDA said it already has 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 emerging technology.

In other FDA actions, the agency in April announced a series of what it called "important changes" to the marketing of the non-steroidal anti-inflammatory class of drugs (NSAIDs), including COX-2 selective and prescription and non-prescription OTC non-selective NSAID medications. A list is available at www.fda.gov/cder/drug/infopage/cox2/default.htm.

The actions "protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

FDA has asked Pfizer Inc. to withdraw Bextra (valdecoxib) from the market because the overall risk vs. benefit profile for the drug is unfavorable, it said. FDA has also asked Pfizer to include a boxed warning on the Celebrex (celecoxib) label. Pfizer agreed to suspend sales and marketing of Bextra in the United States, pending further discussions with the agency.