UPJOHN’s HALCION: "NO FURTHER ACTION" WILL BE TAKEN BY FDA

UPJOHN's HALCION: "NO FURTHER ACTION" WILL BE TAKEN BY FDA following completion of the agency's year-long investigation of the company's reporting procedures for the benzodiazepine hypnotic, Upjohn said Nov. 24. The company said it received a letter from FDA on Nov. 20 stating that the investigation was closed. FDA's Scientific Investigations Division began looking at the drug's files in the autumn of 1991 after Upjohn disclosed that its original NDA for Halcion (triazolam) contained "transcription errors" that misrepresented the side effects seen in a 1972 Phase I study of the drug. "We believe that this exonerates Upjohn and our employees," Upjohn CEO Theodore Cooper, MD/PhD, declared. The company has vigorously denied allegations that the NDA errors were deliberate. In a press release announcing the end of the FDA investigation, Upjohn noted that a libel suit brought by the company against the London Sunday Express ended with a public apology by the newspaper. FDA's conclusion of the investigation of Upjohn's data integrity ends the final phase of the agency's re-review of Halcion. On May 18, FDA's Psychopharmacologic Drugs Advisory Committee concluded that Halcion is safe and effective when used in accordance with more restrictive labeling, revised patient package inserts and unit-of-use packaging adopted in November 1991. The committee reached its decision based on a reconstructed database created by FDA and Upjohn ("The Pink Sheet" May 25, p. 9). Upjohn is continuing with a 10,000-patient trial designed to compare Halcion to Sandoz' Restoril (temazepam). Upjohn announced that it was planning the study at the May advisory committee meeting ("The Pink Sheet" May 25, p. 11). Patient enrollment began on schedule in October and the trial is still expected to end in early 1994, Upjohn said. The re-review of Halcion has been costly to Upjohn. The combination of negative publicity, more restrictive labeling in the U.S. and Europe and product withdrawals in some countries has driven Halcion sales down by almost half since the third quarter of 1991 ("The Pink Sheet" Oct. 19, p. 16). Moreover, Upjohn has been forced to expend significant resources defending the Halcion database and conducting the 10,000-patient trial with just one year of marketing exclusivity left. Halcion comes off patent in October 1993. In May, Upjohn reported that it had devoted almost 150 people full-time to the reconstruction of the Halcion database.