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August 13th, 2009
FDA Assists Patients With Access to Investigational Drugs

The U.S. FDA has recently announced two rules that are intended to explicate accessible strategies for critically ill patients who are interested in obtaining access to investigational drugs and biologics. These rules are explicitly intended for critically ill patients who are not qualified for clinical trial participations and are not privy to reasonable alternative treatment options.

In addition, the FDA has developed a website for patients and health care practitioners to gain knowledge on investigational drugs. Alternative treatment options will include: treatment with FDA approved drugs, given investigational drugs as part of a clinical trial, acquiring investigational drugs outside of a clinical trial.

The FDA’s new rule, “Expanded Access to Investigational Drugs for Treatment Use,” permits patient availability through clarification of methods and guidelines. The second rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies for drug manufacturers, the particular conditions and costs that can be charged to the patient, when the investigational drug is put to use in clinical trials or otherwise used outside the range of a clinical trial.

Margaret Hamburg M.D., Commissioner of Food and Drugs explains that the rule initiatives “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.”


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