The politics of new drug approvals in the United States and Great Britain.

摘要

This dissertation examines the regulatory politics of new drug approvals in the United States and Great Britain. Evidence suggests that since the early 1960's the United States falls on the short end of an international 'drug lag' in which it has been slower to review and approve new drugs than many other industrialized countries. The American regulatory review process and the relative speed at which it operates attract particular scrutiny when compared to the review of new medicines in Britain. First, the dissertation compares the new drug approval process and the history of new drug regulation in each country. I consider the context of the regulatory politics facing each drug licensing agency, the U.S. Food and Drug Administration (FDA) and the British Medicines Control Agency (MCA). The research identifies several areas that exhibit the greatest divergence in the review and approval process. The most substantial determinants include time required to review new drugs, the national standard for determining efficacy, or the effectiveness of a new drug, and also the type or style of review used by each agency. An external signals theory of regulation supplies an explanation for this regulatory divergence. In attempting to serve the public interest, regulatory agencies respond to 'signals' in their surrounding political environment. Agencies observe the response of others to their policies and performance. Four specific factors act as determinants for this divergence in regulatory behavior: regulatory history and path dependence, goal consensus/controversy, political support, and the nature of business-government relations. Empirical evidence used to support the explanations developed in this dissertation is derived from a variety of sources. Interviews with government officials, pharmaceutical industry executives, and other industry analysts constitute the primary source of data. Interviews were conducted on three occasions in Washington, DC during 1995 and 1996 and on one occasion in London in 1997. Interview data are supplemented with data reported by each government on drug review times and first introductions as well as independent survey data on the attitudes of industry officials.