FDA Warns Companies about Promotions of ADHD Drugs

The U.S. Food and Drug Administration (FDA) has made public letters sent to Johnson & Johnson, Shire, Eli Lilly & Co, Novartis and Covidien unit Mallinckrodt in which the drugmakers are warned regarding the irregular and misleading sales pitches and promotions of their medications for attention deficit and hyperactivity disorder (ADHD) through the media, and have been told to stop using these promotions.

Almost all these drugs have sales at the level of millions of dollars. Johnson & Johnson´s Concerta had sales for $ 569 million dollars in the first half of this year; Shire´s Adderall XR pulled in $ 558 million dollars in the same period; Eli Lilly´s Strattera had earnings of $ 283 million dollars.

In their letter to Johnson & Johnson (J&J), the FDA said convention materials for the company´s Concerta extended-release tablets were "false and misleading because they overstated the efficacy of Concerta and omit material facts" regarding the drug´s use. The J&J materials said Concerta "helps children improve academic performance throughout the day."

The FDA pointed out this claim is misleading because none of what the company has stated in the materials has any evidence neither has it been substantiated by clinical experience.

The FDA made objections to U.K.-based Shire for a webpage and video testimonial posted on YouTube featuring television celebrity designer Ty Pennington, in which ADHD medication Adderall XR´s efficacy was overstated, while the video left out important risk information.

Shire has responded to the FDA, saying 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, which would also have contained the appropriate dosing, indication and fair balance."

In its letter to Eli Lilly, the FDA said a sales aid from the Indianapolis-based company overstated the effectiveness of its drug Strattera and minimized important risks. It also suggested use for patients for whom the drug is not approved, the agency said.

"These violations are concerning from a public health perspective because they suggest that Strattera is safer and more effective than has been demonstrated," the FDA said.

Switzerland-based Novartis had its attention brought to slides for Focalin XR, which the FDA said overstated the drug´s efficacy and broadened its approved uses.

Covidien unit Mallinckrodt was also warned about a patient brochure for the drug Methylin, which also minimizes risks and makes unsubstantiated claims. A Covidien spokeswoman said the material was distributed in 2006 by partner Alliant Pharmaceuticals, which is now owned by Sciele Pharma.