Agency Also Finalizes Additional Guidance Regarding Expanded Access (“Compassionate Use”) -

On June 2, 2016, the Food and Drug Administration (FDA) issued final guidance “Individual Patient Expanded Access Applications: Form FDA 3926,” which explains how licensed physicians may use the simplified application process of new Form FDA 3926 to request FDA approval for expanded access to investigational drugs for treatment use for individual patients. The agency also issued two additional final guidance documents aimed at helping physicians, patients, and industry understand the process for accessing investigational drugs for treatment use (“compassionate use”), where medically appropriate. The guidance “Expanded Access to Investigational Drugs for Treatment Use–Questions and Answers” clarifies how FDA implements its regulations regarding expanded access to investigational drugs for treatment use. The guidance “Charging for Investigational Drugs Under an IND–Questions and Answers” clarifies how patients may be charged for investigational drugs, including drugs for expanded access, under FDA’s existing regulations. The new guidance documents do not address expanded access for investigational medical devices.