FDA Modernization Act: implications for oncology

The Food and Drug Administration (FDA) Modernization Act, signed into law on November 21, 1997, represents a sweeping review of existing standards for the approval, labeling, and promotion of prescription medicines. Certain sections of the act will influence access that oncologists and their patients have to new treatments and to information about those treatments. Major impacts of the act include: (1) continued funding of drug reviews by the FDA to assure a continuing stream of new drugs to prevent and treat disease; (2) providing greater flexibility in drug approval by permitting approval on the basis of one clinical trial and confirmatory evidence, and by instituting "fast track" designation to certain drugs that will permit approval on the basis of surrogate end points; (3) improving the access of physicians and patients to developing treatments by instituting a clinical trials databank and by authorizing the use of investigational products in emergencies; and (4) loosening restrictions on dissemination by drug companies of health, economic, and off-label use information, while maintaining incentives to investigate new uses for developing products.