FDA simplifies form for physicians requesting patient access to investigational drugs

The Food and Drug Administration yesterday issued a streamlined form for physicians to request expanded access to investigational drugs and biologics for patients with serious or immediately life-threatening diseases and no comparable or satisfactory alternative therapy. The agency also issued instructions for completing the form, and guidance on when and how to request expanded access and how patients may be charged for investigational drugs. “The FDA has a long history of supporting patient access to investigational treatments and we hope the information released today will help health care professionals, patients and industry to more easily navigate the expanded access process and help patients who qualify to gain access to potentially life-saving investigational treatments,” said FDA Commissioner Robert Califf, M.D.