FDA accelerated pathway jeopardized by Congress | Columnists


Thirty years ago, AIDS patients faced increasing symptoms and the risk of death while awaiting life-saving drugs that had shown enormous promise in clinical trials — but that were hung up in the FDA’s traditional approval process.

In response, Congress sanctioned a new FDA “accelerated approval” pathway that gave patients earlier access to medicines. Lives were spared and our healthcare system finally had solutions to manage a disease that was ravaging our nation.

Kenneth E. Thorpe is a professor of health policy at Emory University and chairman of the Partnership to Fight Chronic Disease.