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Halcion: An Independent Assessment of Safety and Efficacy Data
May
FDA ad hoc committee meets to discuss criminal investigation of Upjohn
PDAC meeting: Halcion is judged to be safe and effective (0.25- and 0.125-mg doses)
June
FDA reviews safety on the basis of data in the new database
• new database numbers judged to be valid
• Halcion judged to be safe
July
United Kingdom announces intention to revoke licenses for Halcion
Public Citizen submits final petition to remove FDA approval
December
FDA investigation of Upjohn terminated
1993
June
United Kingdom revokes licenses for Halcion
1994
April
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
1996
May
FDA task force on Halcion issues its report
1997
April
FDA contracts Institute of Medicine to assess data quality
August
FDA denies Public Citizen petition to remove approval of Halcion
November
IOM report Halcion: An Independent Assessment of Safety and Efficacy Data
