The Food and Drug Administration (FDA) has issued two final rules designed to further expand access to investigational drugs for treatment use and clarify when patients can be charged for investigational drugs.  The rules are effective October 13, 2009. The first rule, “Expanded Access to Investigational Drugs for Treatment Use,” clarifies existing regulations and makes access to investigational drugs for treatment use easier for individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND).  The FDA intends for the rule to “improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies.” The second final rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the circumstances under which charging for an investigational drug in a clinical trial is appropriate; sets forth criteria for charging for an investigational drug for different population categories; and clarifies what costs can be recovered. The final rule will permit charging for a broader range of uses than was explicitly permitted previously.