New rules make the drugs more widely available to seriously ill patients outside clinical trials
WEDNESDAY, Aug. 12 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has published two new rules to help seriously ill patients gain access to investigational drugs and biologics, according to an Aug. 12 release issued by the agency.
Options for these patients include being treated with a drug that has been approved by the FDA, taking an investigational drug as part of a clinical trial, and taking an investigational drug outside of a clinical trial. One of the new rules clarifies procedures and standards to make investigational drugs more widely available to patients. The other rule clarifies which circumstances and costs related to an investigational drug a manufacturer can charge patients for, either as part of or outside of a clinical trial.
The FDA is also launching a Web site where patients and their health care professionals can learn about options for investigational drugs.
"With these initiatives, patients will have the information they need to help them decide whether to seek investigational products. For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand," Margaret A. Hamburg, M.D., Commissioner of Food and Drugs at the FDA, said in a statement.
Access to Investigational Drugs