Halcion: An Independent Assessment of Safety and Efficacy Data (1997)
Chapter: Appendix F: Upjohn Consent to Disclosure
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
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FDA's medical reviews of the NDA
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Complete study reports (Upjohn) for the three pivotal premarketing studies (6024, 6045, 6041)
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Complete study reports (Upjohn) for the three major postmarketing studies (0366, 0373, 0235)
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Case report forms/line listings for the clinical trials (i.e., new data)
1992 Re-Analysis
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FDA Report on the Database remake and re-analysis of 1992
Annual Reports
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The last 10 annual reports for the NDA
1996 Task Force Report
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The task force report (including Dr. Williams' regulatory history of the NDA)
Statistics & Epidemiology
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All reports on Halcion from FDA Office of Epidemiology & Biostatistics
Medical Literature
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The medical literature cited in the task force report
Other
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Transcripts and minutes of the three advisory committee meetings on the drug
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FDA's Biopharmaceutic reviews of the NDA
We understand that physicians' and patients' names will not be disclosed to the public.
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Kenneth F. King, Ph.D. Vice President, Regulatory Affairs Pharmacia & Upjohn Company |
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