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
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
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
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
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>.▪