Using genomics to craft a safer pharmacopeia

Every year some prescriptions go awry, causing the deaths of about 100,000 patients from toxic responses to medications. “We can’t predict who will respond to a drug,” said Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). That could change with the application of genetic knowledge to predict individual responses to medications. It is “more than promise now,” Woodcock said. “It’s starting to happen.”

Woodcock, the keynote speaker at the annual Pharmacogenetics and Medicine Lectures sponsored by Genaissance Pharmaceuticals in April, oversees federal regulation of emerging knowledge about the role genetic variability plays in reactions to medications. Labels for a small number of drugs, she noted, already include information about genetic differences that could affect a patient’s response. The FDA has begun to study electronic formats for providing more of such information to physicians.

According to Woodcock, the FDA has requested that companies provide genetic information when available, but has no plans to require pharmaceutical companies to submit genetic response data about their medications. “We need to understand the science,” she concluded, “so that we can develop an appropriate policy” which will allow the public to benefit from this knowledge.