Hoping to spur a movement toward “personalized medicine,” U.S. regulators issued guidelines that urge companies to submit data on how genetic differences affect the way people respond to drugs.
The research by the Food and Drug Administration is intended to help identify which patients will benefit from a specific drug, and which are more prone to side effects.
The field of science, called pharmacogenomics, is still in its early stages, and drug companies have been concerned about how regulators might use preliminary information.
The new guidelines aim to clarify FDA policy for the industry, an FDA statement said. They outline the type of information regulators want to see from clinical trials of new medicines.
Companies aiming to include pharmacogenomic data on a drug label will be required to submit the information to the FDA for review. In other cases, turning over the findings to regulators will be voluntary. The FDA said it would not use voluntarily submitted information to make drug approval decisions.
Looking for patterns
Scientists will use the data to familiarize themselves with the developing field and look for patterns among different drugs, the guidelines 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,” an FDA statement said.
Some FDA-approved products already employ the technology to tailor treatment. Breast cancer patients, for example, can get tested to see if they have a gene that indicates they will respond to Genentech Inc.’s drug Herceptin.
A tiny glass “gene chip” sold by Roche Holding AG and developed with Affymetrix Inc. technology can identify people who break down medicines too slowly or too quickly. Those people might need different doses than what others take.
Chris Webster, director of regulatory affairs at Millennium Pharmaceuticals Inc., said the new guidelines were important to companies because they show “the FDA takes this seriously.” Millennium is using pharmacogenomics throughout its drug development, Webster said.
The new guidelines are the final version of a draft issued in November 2003.
