U.S. says J&J arthritis drug promotion misleading
Key points
- A Johnson & Johnson promotion for rheumatoid arthritis drug Remicade is misleading because it makes unsupported claims about the drug's effectiveness and omits important information about risks, U.S. regulators said in a letter released on Monday.
- The Food and Drug Administration told the company to immediately stop using materials that contain the misleading information.
- An eight-page sales material presented to doctors "suggests Remicade is safer and more effective than has been demonstrated by substantial evidence or clinical experience," the FDA said in a letter dated Feb.
- Michael Parks, a spokesman for Johnson & Johnson unit Centocor that makes Remicade, said the company was reviewing the letter and "will work with the FDA to resolve any issues."
A Johnson & Johnson promotion for rheumatoid arthritis drug Remicade is misleading because it makes unsupported claims about the drug's effectiveness and omits important information about risks, U.S. regulators said in a letter released on Monday.
The Food and Drug Administration told the company to immediately stop using materials that contain the misleading information.
An eight-page sales material presented to doctors "suggests Remicade is safer and more effective than has been demonstrated by substantial evidence or clinical experience," the FDA said in a letter dated Feb. 11 and posted on the agency's Web site on Monday.
Michael Parks, a spokesman for Johnson & Johnson unit Centocor that makes Remicade, said the company was reviewing the letter and "will work with the FDA to resolve any issues."
Johnson & Johnson shares fell 65 cents, or about 1 percent, in afternoon trading on the New York Stock Exchange.
Written and revised by
Andrey Nailor, M.D.
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