E
Resources Reviewed by the Committee

Title

Contents

Source

General background

FDA Task Force Report

 

FDA

Public Citizen Petition

The Public Citizen Petition to Remove Halcion from the Market

Public Citizen

Upjohn Response to Petition

Upjohn's Response to the Public Citizen Petition

FDA

IOM Study on Sleep

Basic Sleep Research, 1990

IOM

IOM Study on Sleeping Pills

Sleeping Pills, Insomnia, and Medical Practice, 1979

IOM

Miscellaneous information provided by Upjohn

Sales data, patent data, and information on generic compounds

Upjohn

Miscellaneous information provided by FDA

Summary basis of approval, labeling information, information on generic compounds, and guidelines for the clinical evaluation of hypnotic drugs

FDA

Published literature

IOM search

Articles concerning Halcion

IOM

Literature on Halcion

 

FDA



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OCR for page 146
Halcion: An Independent Assessment of Safety and Efficacy Data E Resources Reviewed by the Committee Title Contents Source General background FDA Task Force Report   FDA Public Citizen Petition The Public Citizen Petition to Remove Halcion from the Market Public Citizen Upjohn Response to Petition Upjohn's Response to the Public Citizen Petition FDA IOM Study on Sleep Basic Sleep Research, 1990 IOM IOM Study on Sleeping Pills Sleeping Pills, Insomnia, and Medical Practice, 1979 IOM Miscellaneous information provided by Upjohn Sales data, patent data, and information on generic compounds Upjohn Miscellaneous information provided by FDA Summary basis of approval, labeling information, information on generic compounds, and guidelines for the clinical evaluation of hypnotic drugs FDA Published literature IOM search Articles concerning Halcion IOM Literature on Halcion   FDA

OCR for page 146
Halcion: An Independent Assessment of Safety and Efficacy Data Title Contents Source Upjohn literature search Literature search identifying later studies Upjohn Literature provided by Public Citizen All cited references, including Kales (1996), A Reassessment of Triazolam and Conflicting Scientific Expertise in British and American Medicines Control Public Citizen International data Canadian product monograph for Halcion   Canada Evaluations of Medications for Insomnia in Canada (EMIC)   Upjohn Medicines Control Agency letter Letter from the Licensing Authority to Upjohn, 1992 Public Citizen Report of the Committee on Proprietary Medicinal Products   Upjohn Report of the Committee on the Safety of Medicines   Public Citizen UK Panel Report Report of the Panel of Persons Appointed United Kingdom VAMP Information Information on the General Practice Research Database (previously known as the Value Added Medical Practice [VAMP] Database) Upjohn Premarketing clinical trial data (from the New Drug Application) Preapproval reviews   FDA Premarketing clinical trials   FDA Report of the database remake   FDA

OCR for page 146
Halcion: An Independent Assessment of Safety and Efficacy Data Title Contents Source Upjohn summaries of non-pivotal clinical trials   FDA Efficacy protocols Protocols for 20 studies with lower dosages reviewed for efficacy Upjohn Information from FDA Psychopharmacologic Drugs Advisory Committee meetings Transcript of the PDAC meetings: 1977, 1989, 1992   FDA FDA mailing to 1989 and 1992 PDACS FDA mailing to 1989 PDAC Upjohn Brochures with summary information prepared by Upjohn for the PDAC meetings, 1989 and 1992 Upjohn brochure prepared for the PDAC 1989 Upjohn Integrated Summaries of Safety and Efficacy Integrated safety study Integrated studies' of safety Upjohn Integrated efficacy study Integrated studies of effectiveness Upjohn Integrated dropout listings Integrated summary of safety dropout listings Upjohn Statistical reviews   FDA Epidemiological reviews   FDA Pharmocokinetic and pharmacodynamic data   Upjohn Postmarketing surveillance data Annual Adverse Event Reports   FDA Postmarketing protocols: 1994-1996 Protocols, M/2100/0235, M/2100/0366, and M/2100/0373 FDA Upjohn Annual Reports to FDA, 1990-1997   FDA

OCR for page 146
Halcion: An Independent Assessment of Safety and Efficacy Data Title Contents Source Spontaneous report data FDA memoranda FDA memoranda provided by Diane Wysowski FDA SRS data Data on the FDA Spontaneous Reporting System FDA Use, sales, and prescription data IMS statistics IMS statistics regarding reasons for prescriptions, high dose usage, and chronic usage Upjohn Use statistics Use statistics from IMS and health maintenance organization data regarding reasons for prescriptions, high dose usage, and chronic usage FDA Sales information Number of packages sold in the United States, 1982-1997 Upjohn