The FDA Modernization Act 1997

In 1997, the FDAMA (see US Public Law 105-115, 21 USC 301) expanded the Pre­scription Drug User Fee Act (PDUFA)11 policies by codifying a number of practices that had become common at the FDA. The legislation included provisions regarding user access to experimental drugs and medical devices, information on clinical trials, pharmacy com­pounding, food safety and labeling, and other matters. One provision of the act abolished a prohibition on manufacturers’ dissemination of information about unapproved uses of drugs and devices, permitting them to disseminate peer-reviewed journal articles, provided that they commit to file, within a specified time frame, an application to establish the safety and effectiveness of the unapproved use. The statute also added a new provision that required tracking of the status of postmarketing approval studies. This Act provided (a) more focus on devices with greatest risk/benefits, (2) enhanced/early collaboration with industry, (c) allowed certain changes to devices without prior approval and (d) accelerated the time­line for commercializing safe/effective devices.