Halcion An Independent Assessment of Safety and Efficacy Data (1997) / Chapter Skim
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Introduction
Introduction
Pages 10-19
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Attempts to provide educational and behavioral interventions are receiving increasing attention from the medical 10
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HISTORICAL OVERVIEW OF HALCION Upjohn,l a company that manufactures pharmaceutical products including hypnotic drugs, submitted a New Drug Application (NDA)
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The approval was delayed, however, by a request from the Division of Neuropharmacological Drug Products for additional preclinical animal studies and human bioavailability data. When FDA approved Halcion for clinical use in November 1982, reports of possible problems with the drug were already starting to appear in Europe.
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Indeed, there was sufficient concern about the safety of the drug to cause Public Citizen, a consumer advocacy group, to submit petitions in 1991 and 1992 requesting that FDA remove Halcion from the U.S. market.4 Spontaneous Reports Interpretation of the spontaneous reports was a matter of some debate within FDA.
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used statistical methods to adjust for many factors, including publicity, variability in rate ratios, manufacturers' reporting practices, and trends in overall reporting rates, among others. This analysis resulted in reduced overall risk ratios (e.g., ~ to ~ relative risk for depression and 26 to ~ relative risk for amnesia)
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This was to include an assessment of the following: · the adequacy of the study designs and quantitative endpoints used in the major clinical trials of Halcion; · the quality and quantity of postmarketing data with respect to adverse drug reactions; · the overall confidence in the data on the effectiveness, adverse events, and side effects of Halcion at different doses and for different durations, including those specified in the current product labeling; and · the need for additional studies to clarify and characterize the risk and efficacy profiles of Halcion. If additional studies were deemed necessary to help clarify and characterize the risk and efficacy profiles of Halcion, the committee was instructed to describe what specific types of studies would be needed.
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meeting, where PMC recommended approval but did not specify dose Division of Neuropharmacological Drug Proclucts issues a not approvable letter because of inadequate preclinical and bioavailability data Halcion approved for clinical use at a close of 1.0 mg in The NetherIancis FDA Division of Neuropharmacological Drug Proclucts issues a not approvable letter because of deficiencies in animal studies United Kingdom approves Halcion for clinical use C van der Kroef reports a "syndrome" The Netherlands suspends Halcion from its market Continues
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. resu omission First"approvable" letter FDA medical officer review: adverse events reports from Europe Second approvable letter Approval letter Summary basis of approval at doses of 0.25 and 0.5 mg FDA disqualifies data from one investigator because of an unrelated incident 1 983 April 1 987 February June 17 Upjohn introduces 0.125-mg tablet France withdraws 0.5-mg tablet from French market FDA medical officer's review: reduction of adult dose from 0.5 to 0.25 mg Continues
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begins investigation of Upjohn Public Citizen submits first petition to remove FDA approval Reentry of original data into a new database FDA investigation of Upjohn suspended Continues
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INTRODUCTION BOX 1-2 Continued May June July December 1 993 June 1994 April 1 996 May 1 997 April August November 19 FDA ad hoc committee meets to discuss criminal investigation of Upjohn PDAC meeting: Halcion is judged to be safe and effective (0.25- and 0.~25-mg doses) FDA reviews safely on the basis of data in the new database new database numbers judged to be valid Halcion judged to be safe United Kingdom announces intention to revoke licenses for Halcion Public Citizen submits final petition to remove FDA approval FDA investigation of Upjohn terminated United Kingdom revokes licenses for Halcion FDA medical officer review: labeling and packaging changes FDA commissioner requests formation of an FDA task force on Halcion to examine criminal misconduct, scientific questions, and regulatory concerns FDA task force on Halcion issues its report FDA contracts Institute of Meclicine to assess data quality FDA denies Public Citizen petition to remove approval of Halcion fOM report Ha/cion: An /nclependenf Assessment of Safely and Efficacy Data
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