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UPJOHN SETTLES DEA SCHEDULED-DRUGS SAMPLING VIOLATIONS CASE

Executive Summary

UPJOHN SETTLES DEA SCHEDULED-DRUGS SAMPLING VIOLATIONS CASE with a $ 600,000 payment and an agreement to pay $ 500,000 more if the company again violates the conditions set out in a June 4 consent decree. The decree settles a complaint filed June 3 in Portland, Ore. federal court alleging that Upjohn violated the Controlled Substances Act by providing physicians with samples of the Schedule IV drugs Xanax (the anxiolytic alprazolam) and the hypnotic Halcion (triazolam) without adequate recordkeeping. The complaint cites 18 cases of deliveries to physicians where an invalid Drug Enforcement Agency registration number was recorded for the recipient, two cases where a registration number other than the recipient's was recorded, and 10 cases where no DEA registration number was recorded. In a statement issued following the settlement, Upjohn said that "the reporting errors were primarily clerical in nature; it is important to note that the DEA investigation found no evidence of diversion of Halcion or Xanax to illicit uses," Upjohn stressed. The settlement does not constitute an admission by Upjohn of any violations of the Controlled Substances Act. The case, filed by the Justice Department, sought the maximum $ 25,000 per count civil penalty (a total of $ 750,000), a "permanent injunction" enjoining Upjohn from any further violations, and reimbursement for the costs of its investigation. Oregon Assistant U.S. Attorney Riley Atkins, who negotiated the settlement, said the Upjohn $ 1.1 mil. consent decree "is the largest sum ever imposed against a defendant, corporate or otherwise, under the civil penalty provisions of the Controlled Substances Act." The suit stemmed from combined DEA and U.S. Attorneys' office investigations in Oregon, Orlando, Cincinnati, Puerto Rico, and Grand Rapids, Mich. FDA was not involved in the investigations, Atkins said. The settlement ends investigations that began in May 1989 at Upjohn's Portland distribution center. Oregon's Atkins said in a June 4 press release that the investigation revealed a pattern of repeated violations at the other Upjohn distribution centers, hence the coordinated government effort. In addition to the civil penalty, the consent decree requires Upjohn's sales force to stop distributing samples of controlled substances for five years. Physicians instead must submit a written request to the company that includes a copy of their DEA registration certificate. Upjohn is also required to "review the Federal Register on a daily basis to assure that the practitioner's registration has not been revoked." Upjohn is given 60 days to introduce the new practices.
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