Aggregate Analysis of the Export Petition and Waiver Process: A Pharmaceutical Industry Perspective
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
F’rinted in the USA. All rights reserved.
AGGREGATE ANALYSIS OF THE EXPORT PETITION AND WAIVER PROCESS: A PHARMACEUTICAL INDUSTRY PERSPECTIVE TRAVISS. FISHER,PHARMD Visiting Scientist, U.S. Regulatory Affairs, Eli Lilly and Company, Indianapolis, Indiana
THOMASL. COPMANN,PHD Senior Director. U.S. Regulatory Affairs, Eli Lilly and Company, Rockville, Maryland
In an effort to harmonize the introduction of drugs onto the global market, many United States pharmaceutical companies have focused on the globalization of their drug development process and have, therefore, increased the number of clinical registration studies conducted outside of the United States. A key Food and Drug Administration requirement that must be addressed to support the conduct of these trials outside of the United States is that of the export waiver: To ascertain the efficiency of the current export petition and waiver process, export data from 1998 to 2001 were evaluated. The primary metrics included mean time to approval (days), range of approval days, number of export waiver requests, and export receiving countries. Linear regression was used to calculate the rate of approval time change and identify the qualitative trend with respect to this change. Using this approach, the rate of increase in approval time for export waivers was determined to be eight days per year: Therefore, over the past few years, there has been a steady increase in the number of days required to receive export waivers from the Food and Drug Administration.
Key Words: Export petition and waiver; Clinical studies; Process improvement; Metrics; Aggregation
INTRODUCTION TODAY, MANY UNITED STATES pharmaceutical companies have focused on the globalization of their drug development process and, therefore, have increased the number of clinical studies conducted outside of the United States. In order to conduct foreign studies with an investigational drug manufactured in the United States, companies are subject to provisions set forth in the Federal
Food, Drug, and Cosmetic (FD&C) Act and enforced by the Food and Drug Administration (FDA). Of specific importance are the sections of the act detailing the requirements for exporting unapproved drugs. The Federal Food and Drugs Act of 1906 first addressed the issue of an export waiver in the context that “no article shall be deemed misbranded or adulterated within the provisions of this act when intended for export to a foreign country . . . This provision to secure a waiver from the requirements of the act remained in effect until enactment of the FD&C Act of 1938, which provided the dis”
Reprint address: Travis Fisher. Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285.
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tinction between a “drug” and a “new drug.” The impact of this distinction was dramatic for pharmaceutical companies, which were no longer able to ship new or unapproved drugs internationally. It was not until the passage of the Drug Export Amendment Act of 198
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