ASCO & FDA partner to streamline expanded access process

For many patients who have run out of treatment options, investigational drugs are usually seen as a last hope. While clinical trials are the best way for patients to get access to unapproved drugs, many are ineligible, leaving a little-known loophole called compassionate use. In the past, physicians and their patients had to do a lot of legwork on their own to get access to unapproved drugs outside of a clinical trial, which is usually approved on a case-by-case basis between each patient and drug maker--a time-consuming and complicated process. But today, on the opening day of the largest cancer meeting in the world, the American Society of Clinical Oncology announced a partnership with the Food and Drug Administration that could help streamline the process.Last year, the FDA updated its expanded access regulations, but "many physicians and most patients do not understand how to take advantage of unapproved therapies," said George W. Sledge, Jr., MD, ASCO's President-Elect, at today's press conference. Hopefully, the new resources developed by the two groups will help educate both patients and doctors on expanded access. The set of resources, found at university.asco.org, can aid doctors, and ultimately patients, in requesting expanded access drugs. Although the resources are geared toward physicians, it also helps take some of the burden off of the patient to do much of the work themselves. The resources include a process for requesting expanded access, explanation of the doctor's legal responsibility for treating patients with investigational drugs outside of a clinical trial, and templates that can help with requesting treatments from a drug manufacturer. You can read more about expanded access in "Ethics of Access." The FDA also has information on expanded access at www.fda.gov.