FDA, drug makers to study drug side-effects

A group of the world's biggest drug makers have come together with the FDA to look into the reasons why a small subset of patients have medication severe side effects. To attack the problem, the International Severe Adverse Events Consortium hopes to use personalized medicine. The partners will be working to use genetic data to design less-dangerous drugs, as well as to find patients at risk for serious side effects.

Not only will the coalition bring the FDA under the same mantle as drug companies, it will also lead to a major lowering of competitive barriers. The drug companies involved, including Abbott, GlaxoSmithKline, Johnson & Johns and Roche, will share data with researchers across the world using a mutual database. The FDA's role, meanwhile, will be to offer advice on how to design the research and make sense of the results. Other partners include Columbia University and two European academic consortia.

To find out more about the coalition:
- read this piece in The Boston Globe

Related Articles:
Can we afford personalized medicine? Report
Personalized medicine initiative hopes for grant. Report
Congress poised to give more power to the FDA. Report
Researcher challenges FDA approval process. Report
Bill giving FDA more drug safety powers could pass. Report
FDA emphasizing speed over safety? Report
FDA boosts reviews for new drugs. Report
Report faults FDA's post-marketing vigilance. Report