National Academies Press: OpenBook

Halcion: An Independent Assessment of Safety and Efficacy Data (1997)

Chapter: Appendix F: Upjohn Consent to Disclosure

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Suggested Citation:"Appendix F: Upjohn Consent to Disclosure." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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F
Consent to Disclosure

For the purposes of this study, Pharmacia and Upjohn, Inc., agreed to disclose all pertinent information to the IOM Committee. A copy of their consent agreement follows.

Suggested Citation:"Appendix F: Upjohn Consent to Disclosure." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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Consent to Disclosure

On behalf of Pharmacia & Upjohn Company, I hereby consent to disclosure of the following documents by the United States Food and Drug Administration (FDA) to the Institute of Medicine at the National Academy of Science (IOM) for the purpose of performing an independent review of the data. I understand that the documents as disclosed to IOM may contain trade secrets and confidential commercial or financial information within the meaning of 18 U.S.C. 1905, 21 U.S.C. 331(j) and 5 U.S.C. 552(b)(4) and agree to hold FDA harmless for any injury caused by FDA's disclosing the documents to IOM. IOM is authorized to include any portion of any document so disclosed, as well as any description or summary of any document so disclosed, in a report to be made available to the public by IOM at the conclusion of the independent review.

Documents to be disclosed:

NDA Clinical Trial Data

  1. FDA's medical reviews of the NDA

  2. Complete study reports (Upjohn) for the three pivotal premarketing studies (6024, 6045, 6041)

  3. Complete study reports (Upjohn) for the three major postmarketing studies (0366, 0373, 0235)

  4. Case report forms/line listings for the clinical trials (i.e., new data)

1992 Re-Analysis

  1. FDA Report on the Database remake and re-analysis of 1992

Annual Reports

  1. The last 10 annual reports for the NDA

1996 Task Force Report

  1. The task force report (including Dr. Williams' regulatory history of the NDA)

Statistics & Epidemiology

  1. All reports on Halcion from FDA Office of Epidemiology & Biostatistics

Suggested Citation:"Appendix F: Upjohn Consent to Disclosure." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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Medical Literature

  1. The medical literature cited in the task force report

Other

  1. Transcripts and minutes of the three advisory committee meetings on the drug

  2. FDA's Biopharmaceutic reviews of the NDA

We understand that physicians' and patients' names will not be disclosed to the public.

Kenneth F. King, Ph.D.

Vice President, Regulatory Affairs

Pharmacia & Upjohn Company

Date

Suggested Citation:"Appendix F: Upjohn Consent to Disclosure." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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Page 150
Suggested Citation:"Appendix F: Upjohn Consent to Disclosure." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 151
Suggested Citation:"Appendix F: Upjohn Consent to Disclosure." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 152
Next: Appendix G: Committee and Staff Biographies »
Halcion: An Independent Assessment of Safety and Efficacy Data Get This Book
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Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)--a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret. In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed.

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