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 clinical trials or through the expanded access process. Read the rest of this entry »