Critical Path Progresses with Genetic-Based Adverse Event Report

Rockville, MD (Feb. 19)-The US Food and Drug Administration and the International Serious Adverse-Event Consortium (SAEC) released last week the first data on certain types of genetic-based adverse drug events. The report, issued Feb. 10, 2009, focuses on the genetics associated with drug-induced serious skin rashes such as toxic epidermal necrolysis. The findings, which help predict an individual’s risk of developing allergic skin reactions, are meant to help healthcare professionals understand the genetic basis of certain adverse drug events.

SAEC is a nonprofit partnership of pharmaceutical companies, the Wellcome Trust, and academic institutions focused on research relating to the genetics of drug-induced serious adverse events. The organization has “fulfilled a key goal of the Critical Path Initiative by providing the research community with public access to new genomic data on adverse drug events,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press release. FDA launched the Critical Path Initiative in 2004 to stimulate a national effort to modernize the sciences.

“This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient’s risk for experiencing an adverse drug event,” said Woodcock in the release.