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FDA DIRECTS KABI PHARMACIA TO CONDUCT CORRECTIONAL AD CAMPAIGN

 WASHINGTON, Aug. 2 /PRNewswire/ -- The Food and Drug Administration today announced that Kabi Pharmacia Inc., Piscataway, N.J., will be required to undertake an extensive campaign to correct misleading promotion and advertising for its ulcerative colitis drug Dipentum.
 In a consent decree signed by FDA and Kabi, the U.S. District Court in New Jersey entered a permanent injunction against Kabi and its president and chief executive officer Anders Wiklund, with regard to the marketing of Dipentum, and it specifically calls for the company to do the following:
 -- revise its promotional and advertising materials for Dipentum and for one year seek FDA approval for them while destroying existing promotional and advertising materials;
 -- undertake an FDA-approved corrective training program for the company's sales ("detail"), marketing, regulatory and legal personnel on conducting their promotional practices in compliance with the law, and the training may include employee testing;
 -- begin a six-month corrective advertising campaign that will include remedial advertisements in medical journals and letters to each physician contacted about Dipentum by the company's sales force; and
 -- pay FDA $85,000 for the cost of its one-year investigation into Kabi's promotional and advertising practices for Dipentum; and
 -- establish a $300,000 escrow account to pay for the corrective campaign and to reimburse FDA for its oversight.
 "Some have argued that the goal of drug promotion is to educate physicians," said FDA Commissioner David A. Kessler, M.D. "In this case, the company's goal was to increase sales at the expense of patient care.
 "Promotion that is not aimed at the proper treatment of patients is one of the factors contributing to the rising costs of health care in this country, and we all need to address that issue head-on," he added.
 In a complaint filed with the consent decree of permanent injunction, the government maintained that the company illegally promoted Dipentum as being indicated for the treatment of mild, moderate and severe active ulcerative colitis; for use in children; as superior to sulfasalazine, and as a "first choice" therapy in the treatment of ulcerative colitis.
 Dipentum was approved by FDA on July 31, 1990, for a single use only -- to maintain periods of remission of ulcerative colitis in adults. Moreover, because of concerns about the high incidence of diarrhea that occurs with Dipentum -- a troublesome side effect in ulcerative colitis patients -- FDA restricted its approval to use only by adults intolerant of sulfasalazine.
 In overseeing the corrective training program for Kabi's employees, FDA officials will require that they be instructed to tell physicians only about approved uses of Dipentum and not to make unsupported product superiority claims. Misleading and false claims made by Kabi detail representatives in sales presentations to physicians are a major focus of the corrective campaign.
 The permanent injunction also provides that FDA may require the corrective advertising campaign to admit that Kabi made false or misleading claims for Dipentum and that the drug is not approved for the treatment of active ulcerative colitis, for any pediatric use or for the maintenance of remission of ulcerative colitis in patients other than those intolerant of sulfasalazine.
 FDA is one of eight Public Health Service agencies within HHS.
 -0- 8/2/93
 /NOTE: Attention TV Broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Jim O'Hara, 301-443-1130; or Mike Shaffer, 301-443-3285 or, after hours, 301-831-9364, both of the Food and Drug Administration/


CO: Food and Drug Administration; Kabi Pharmacia Inc. ST: District of Columbia, New Jersey IN: HEA MTC ADV SU: EXE

IH-DC -- DC009 -- 8287 08/02/93 10:46 EDT
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Publication:PR Newswire
Date:Aug 2, 1993
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