Johnson & Johnson's Centocor subsidiary has had its knuckles rapped by the US Food and Drug Administration for making misleading claims in promotional materials for its big-selling rheumatoid arthritis drug, Remicade (infliximab).
The FDA told the company to stop using the eight-page visual aid, saying that it contained “unsubstantiated effectiveness claims and omits information on the risks associated with Remicade in the treatment of rheumatoid arthritis.” Specifically, the agency took issue with graphs in product presentations that implied Remicade can reverse or heal the disease process in early stages, rather than slow progression.
The promotional material that has upset the FDA “suggests Remicade is safer and more effective than has been demonstrated by substantial evidence or clinical experience,” according to the agency. Side effect information – including the black box warning Remicade carries to alert prescribers and patients to the risk of infections while taking the drug – were given little prominence and buried at the end of the brochure, according to the FDA.
J&J said it would comply with the FDA’ request and work with the agency to resolve any issues arising from the case.
Along with Amgen’s Enbrel (etanercept), Remicade dominates the market for biological drugs used to treat rheumatoid arthritis, together taking around 80% of the total market [[06/08/04h]]. Remicade is still growing rapidly – it posted a 31% hike in fourth-quarter 2004 sales to $598 million dollars [[26/01/05c]] – but the competition is on the march, with Abbott Laboratories’ Humira (adalimumab) growing fast and new agents such as Roche’s Rituxan (rituximab) and UCB/Celltech’s CDP 870 poised to muscle in on the category.