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OCR for page 150
Halcion: An Independent Assessment of Safety and Efficacy Data
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.
OCR for page 151
Halcion: An Independent Assessment of Safety and Efficacy Data
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
FDA's medical reviews of the NDA
Complete study reports (Upjohn) for the three pivotal premarketing studies (6024, 6045, 6041)
Complete study reports (Upjohn) for the three major postmarketing studies (0366, 0373, 0235)
Case report forms/line listings for the clinical trials (i.e., new data)
1992 Re-Analysis
FDA Report on the Database remake and re-analysis of 1992
Annual Reports
The last 10 annual reports for the NDA
1996 Task Force Report
The task force report (including Dr. Williams' regulatory history of the NDA)
Statistics & Epidemiology
All reports on Halcion from FDA Office of Epidemiology & Biostatistics
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Halcion: An Independent Assessment of Safety and Efficacy Data
Medical Literature
The medical literature cited in the task force report
Other
Transcripts and minutes of the three advisory committee meetings on the drug
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
Representative terms from entire chapter:
study reports
