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Regulatory Reform Act

United States. Congress. House. Committee on the Judiciary. Subcommittee on Administrative Law and Governmental Relations

Published: 1984

Total Pages: 1186


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This classic text, originally published in 1948, is a study of the public administration movement from the viewpoint of political theory and the history of ideas. It seeks to review and analyze the theoretical element in administrative writings and to present the development of the public administration movement as a chapter in the history of American political thought.The objectives of The Administrative State are to assist students of administration to view their subject in historical perspective and to appraise the theoretical content of their literature. It is also hoped that this book may assist students of American culture by illuminating an important development of the first half of the twentieth century. It thus should serve political scientists whose interests lie in the field of public administration or in the study of bureaucracy as a political issue; the public administrator interested in the philosophic background of his service; and the historian who seeks an understanding of major governmental developments.This study, now with a new introduction by public policy and administration scholar Hugh Miller, is based upon the various books, articles, pamphlets, reports, and records that make up the literature of public administration, and documents the political response to the modern world that Graham Wallas named the Great Society. It will be of lasting interest to students of political science, government, and American history.
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
This timely and well-researched study describes for the first tim ethe astonishing acquiecence of executive agency officials, members of Congress, and federal judges to Ronald Regan's assertion of extraordinary new presidential power over the federal regulatory process—the controversial Executive Order 12291.From Harry Truman through Jimy Carter, chief executives complained that federal bureaucrats disregarded their policy preferences. presidential influence over regulatory rule making was limited: congressional committees and interest groups commanded more attention. Then in February 1981 Ronal regan abruptly departed from tradition by ordering that regulatory agencies must submit proposed guidelines for Office of Management and Budget approval.Barry D. friedman describes how the executive agencies and Congress responded warily and with skepticism, yet allowed the changes to remain; the judiciary was also willing to retreat from time-honored precedents that had preserved agency prerogative and now accorded due respect to the revolutionary Regan reform initiatives. Institutions that competed for leverage in the system continued to exercise restraint in their mutual relations because they recognized taht all benefitted from the others' viability.This book shows that conventional political science theories and models are now obsolete because of the eruption of presidential control into bureaucratic affairs. new review procedures have restructured relations between the president and the agencies and among the government's three branches. because of Regan's radical initiative, President Bill Clinton and his successors will sit at the bargaining table when regulation policy is developed in Washington, and political theorists will have to work from a new conception of presidential prerogative.