The FDA has criticized drugmakers after they misled consumers about medicines to treat attention deficit disorder.
The Food and Drug Administration sent letters to Lilly, J&J, Novartis, Shire and Mallinckrodt, a unit of Covidien, with complaints about certain promotions.
Shire drew objections for a webpage and video testimonial posted on YouTube featuring television celebrity designer Ty Pennington. Both overstated the efficacy of Adderall XR, and the video left out important risk information, the FDA said.
Shire spokesman Matt Cabrey said the video posting "was made in error,” and it was never intended to be a video posting on any site except a Shire owned and managed website. He added that the company is responding to the FDA and committed to complying with promotion rules.
The FDA said a sales ad from Lilly overstated the effectiveness of its drug Strattera and minimized important risks. It also suggested use for patients for whom the drug is not approved.
Meanwhile, in a letter to J&J, the FDA said convention materials for Concerta extended-release tablets were 'false and misleading' because they overstated the efficacy of the drug and 'omit material facts' regarding its use.
The J&J materials said Concerta 'helps children improve academic performance throughout the day'. The FDA said the claim was misleading because it 'had not been shown by substantial evidence or substantial clinical experience'.