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1993.08.02 :  Kabi Pharmacia, Inc Campaign -- Ulcerative Colitis Drug

Contact:  Jim O'Hara (301) 443-1130
          Mike Shaffer (301) 443-3285
August 2, 1993

    The Food and Drug Administration 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 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 this issue head-on," he said.
    In a complaint filed with the consent decrees 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.