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The Access to Medical Treatment Act (HR 2792) would provide a much-needed federal statutory authority for Americans to use therapies and devices that have not yet been approved (or which may never be approved) by the Food and Drug Administration (FDA). This would include three basic categories of drugs and devices: 1) those that are presently undergoing clinical trials and are only available now to those patients who fit the tightly designed protocols; 2) those that have been approved and used in other countries but have not been approved by the FDA and are therefore unavailable to Americans; and 3) non-patentable drugs and those that are not in the drug-approval pipeline.

This bill contains numerous patient protections, including strict informed consent procedures.  Patients must visit an authorized practitioner to access unapproved drugs and devices.  Practitioners may not exceed their scope of practice or advertise unapproved drugs or devices.  Information about beneficial results must be reported to the National Center for Complementary and Alternative Medicine at NIH, and information about negative results must be reported to the Centers for Disease Control and Prevention.  Even one adverse event will result in the unapproved product being removed from the market.