The 1997 Modernization Act moved in the direction of “reform”; thus, most of its requirements were in the direction of reducing FDA bureaucracy and speeding drugs and devices to patients. The act was, however, at best a modest reform package. Specifically, the Modernization Act reauthorized user fees for another five years, codified rules for fast-track approval, codified the rule that only one adequate and well-controlled clinical study and confirmatory evidence could be the basis of approval, and codified restrictive FDA policies on dissemination of information regarding off-label uses of drugs. (Washington Legal Foundation v. Friedman found such restrictions unconstitutional and further opened up the ability of firms to disseminate off-label information). Concerning medical devices, the Modernization Act exempted most Class I and some Class II devices from premarket approval, and it increased physician authority to use investigational devices. Finally, in a variety of clauses, the FDA was required to provide manufacturers with better and more timely information concerning its procedures. More information is available in the history section. The bill can be found online here.