Overreaching Efficacy Claims Prompt Warnings to Drug Companies

Five drug companies have been given warnings by the Food and Drug Administration (FDA) for inappropriately promoting their drugs indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD).

The five warning letters about the content of advertisements to both consumers and health care professionals were sent to the companies in September.

Eli Lilly and Co. was cited for false or misleading information in a handbook for sales representatives that “broadens the indication for and overstates the efficacy of Strattera [atomoxetine], omits material facts, and minimized important risks associated with Strattera,” according to the warning letter.

Mallinckrodt Inc., a unit of Covidien Ltd. and the maker of Methylin (methylphenidate hydrochloride) tablets and oral solution, was told to stop disseminating a patient brochure that contained information that“ overstates the efficacy of Methylin, omits and minimizes risks associated with Methylin, and contains ... unsubstantiated comparative claims.”

Novartis was cited for overstating the efficacy of Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules in a professional slide deck, a type of promotional material used in sales presentations to health care professionals.

Johnson and Johnson was told to stop using a brochure at professional conventions for Concerta (methylphenidate) extended-release tablets.

The warning letter to Shire, the maker of Adderall XR (mixed amphetamine salts) capsules, cited the company for overstating efficacy and omitting important risk information on a Web page and in a video posted on YouTube and the company Web site, which featured a testimonial by television personality Ty Pennington. The video posting had already been removed last year, according to a report by Bloomberg.com.

The FDA told all five companies to immediately stop disseminating the materials cited and to outline plans to comply with regulatory requirements for drug promotions. All of the companies have said they intended to work with the FDA to address the agency's concerns.

The FDA recently has been criticized by the Government Accountability Office for lacking the manpower and resources to adequately monitor and regulate illegal promotional activities of drug companies (Psychiatric News, September 9).

The warning letters and promotional materials at issue are posted at<www.fda.gov/cder/warn/warn2008.htm>.▪