Tag Archives: compassionate use

FDA Issues Final Rule to Clarify Patient Access to Experimental Drugs

In an effort to broaden and clarify access by individual patients to experimental medicines that have not yet obtained FDA approval or haven’t been approved for a new use, the Food and Drug Administration issued two new rules on August 12, 2009. The Expanded Access rule establishes how seriously ill individual patients or groups of patients can obtain investigational medicines while at the same time preserving the clinical trials process. The Charging rule clarifies when a manufacturer of an investigational drug may charge for it and what costs can be recovered in those charges. In addition, the FDA established a website for consumers to explain access to investigational drugs through