• FDA Cites Five Drug Companies for ADHD Ads
  • October 28, 2008
  • Law Firm: Manatt, Phelps & Phillips, LLP - Los Angeles Office
  • The Food and Drug Administration has sent warning letters to five pharmaceutical companies over online ads and other marketing materials for drugs to treat attention deficit hyperactivity disorder.

    An agency spokesperson said that the FDA sent the letters, which are posted on the agency’s Web site, after a review of promotional materials for the class of prescription hyperactivity drugs found a number of violations. The drugs included Johnson & Johnson’s Concerta, Shire Ltd.’s Adderall XR, Eli Lilly & Co.’s Strattera, Novartis’s Focalin XR, and Mallinckrodt Inc.’s Methylin.

    A YouTube video featuring Ty Pennington from ABC’s “Extreme Makeover: Home Edition,” and a Web ad were cited in the warning letter to Shire for overstating efficacy and omitting “important safety information” regarding Adderall. A Shire spokesperson said the Web ad “was made in error” and the company is “committed to complying with both the letter and the spirit” of the agency’s regulations. He said the YouTube video, which was taken down last year, was not supposed to have gone up on the Web site without additional information on dosing and use.

    Eli Lilly, which said it “will work with the FDA to address their concerns,” was cited for marketing materials used by salespeople that allegedly overstated the effectiveness and minimized risks of Strattera.

    The agency cited J&J for ad panels used at conventions, as well as a consumer site, saying the materials overstated the effectiveness of Concerta. A spokesperson said the company “will work closely with the FDA to address the issues raised in its letter.”

    A Mallinckrodt spokesperson said the company is “preparing a response to address the FDA’s concerns” that a patient brochure for Methylin overstated effectiveness and omitted risk information.

    The agency’s letter to Novartis complained that material for Focalin, including a company Web page and a “professional slide deck,” overstated effectiveness. A company spokesperson said Novartis would review the letter and respond to the FDA.