FDA Halcion EIR review involves Dept. of Justice, Upjohn discloses.

Executive Summary

FDA HALCION REVIEW INCLUDES JUSTICE DEPT. PARTICIPATION, Upjohn disclosed in a proxy statement for its proposed merger with Pharmacia. The proxy statement declares that FDA, "with the assistance of the U.S. Attorney's Office in Grand Rapids, Mich., is conducting a review of the FDA's prior inspection report on Halcion, including an assessment of the conclusions of the report, the approval of the drug, related FDA processes and procedures and the violations of any laws." The proxy continues: "Upjohn cannot predict the outcome of this review."