FDA issues expanded access rules

FDA issued final rules to clarify existing regulations governing expanded access to investigational drugs or biologics and the specific circumstances in which companies can charge for an investigational drug in a clinical trial or in an expanded access setting. FDA said the expanded access rule is intended to improve access to investigational drugs by individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment IND. Under the rule, FDA must determine that the patient has a serious or immediately life-threatening disease and that there is no comparable alternative therapy; the benefit justifies the potential risks of the treatment; and that use of the investigational drug does not interfere with the product's clinical development program. The rule can be found at http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf ...