Patient groups, PhRMA to huddle on expanded access

Four patient advocacy organizations and the Pharmaceutical Research and Manufacturers of America will discuss compassionate use on Dec. 10 at an invitation-only workshop in Washington entitled "Role of Investigational New Drugs in Patient Care."

Patient-group sponsors include the American Autoimmune Related Diseases Association, Cancer Support Community, Center for Information and Study on Clinical Research, and the Leukemia and Lymphoma Society. Senior FDA officials are expected to participate. According to the invitation, "The workshop will convene patient and provider groups, industry, academia, think tanks, and government regulators to explore approaches to optimize the existing Food and Drug Administration (FDA) Expanded Access process, while helping to ensure timely patient access to safe and effective medicines." ...