FDA WARNING_LETTER - Johnson & Johnson Pharmaceutical Research and Development, L.L.C. - September 25, 2008

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a Warning Letter to Johnson & Johnson Pharmaceutical Research and Development, L.L.C. regarding promotional materials for Concerta (methylphenidate HCI) Extended-release Tablets [CII]. The review of professional convention panels and a consumer webpage found the materials to be false or misleading, misbranding the drug in violation of the Federal Food, Drug, and Cosmetic Act and FDA regulations (21 U.S.C. 352(a), 352(n), & 321(n); 21 CFR 202.1(e)(3)(i) & (e)(6)(i)). Specifically, the materials overstated Concerta's efficacy by claiming it helps children improve academic performance throughout the day and asserting improvement in a broad range of adolescent after-school activities, neither of which is supported by substantial evidence. Additionally, five of the six convention panels omitted the material fact regarding the risk of long-term growth suppression. Johnson & Johnson is required to immediately cease disseminating these violative promotional materials. The company must submit a written response by October 7, 2008, detailing its intent to comply, listing all similar violative materials, and outlining a plan for discontinuing their use. The FDA stressed the company's responsibility to ensure all Concerta promotional materials adhere to applicable regulatory requirements.