FDA Cites J&J's Centocor for Misleading Remicade Promotion
The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued Johnson & Johnson subsidiary Centocor an untitled letter for a visual aid that it says misrepresents the effectiveness of rheumatoid arthritis (RA) drug Remicade.
The letter said the Remicade (infliximab) visual aid is misleading because it suggests the drug "can reverse or heal the disease process in patients with RA." The DDMAC noted that the prominent use of the claim "IMPROVEMENT" in the aid adds to an overall impression that Remicade can reverse or heal the damage caused by RA.
"Although Remicade is indicated for 'inhibiting the progression of structural damage ... in patients with moderately to severely active rheumatoid arthritis,' the FDA is not aware of substantial evidence or substantial clinical experience to support claims that Remicade can reverse or heal the damage caused by RA," the DDMAC wrote.
In addition to the misleading claims, the promotional material failed to include risk information in each of its sections as required to qualify the safety and effectiveness claims for Remicade.
The agency ordered Centocor to immediately cease disseminating the aid and provide a written response to the untitled letter by Feb. 28. To view the untitled letter, go to http://www.fda.gov/cder/warn/2005/Remicade-letter.pdf (http://www.fda.gov/cder/warn/2005/Remicade-letter.pdf).