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RPT-US criticizes Lilly, J&J, Shire for misleading drug ads
September 26, 2008 / 10:39 PM / 9 years ago

RPT-US criticizes Lilly, J&J, Shire for misleading drug ads

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WASHINGTON, Sept 26 (Reuters) - Eli Lilly (LLY.N), Johnson & Johnson (JNJ.N) and other drugmakers misled consumers about medicines to treat attention deficit disorder in various sales pitches, U.S. regulators said in letters released on Friday.

The Food and Drug Administration sent letters to Lilly, J&J, Novartis NOVN.VX, Shire (SHP.L) and Covidien COV.N unit Mallinckrodt 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, which would also have contained the appropriate dosing, indication and fair balance.” The company is responding to the FDA and committed to complying with promotion rules, he said.

The FDA said a sales aid 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, 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.

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 Concerta and omit material facts” regarding the drug’s use.

The J&J materials said Concerta “helps children improve academic performance throughout the day.” That claim was misleading because it “had not been shown by substantial evidence or substantial clinical experience,” the FDA said.

The FDA said slides from Novartis for Focalin XR overstated the drug’s efficacy and broadened its approved uses.

A letter to Covidien unit Mallinckrodt said a patient brochure for the drug Methylin also minimized risks and made unsubstantiated claims.

Covidien is reviewing the letter and preparing a response, company spokeswoman Erica Abbett said. The material was distributed in 2006 by partner Alliant Pharmaceuticals, which is now owned by Sciele Pharma SCRX.O, she said.

Tricia Geoghegan, a spokeswoman for J&J unit McNeil Pediatrics, said the company would work with the FDA to resolve the issues raised in the letter. “We are committed to providing patients and consumers with accurate and balanced information,” she said.

Novartis is reviewing the FDA letter and will respond to the agency, company spokeswoman Pamela McKinlay said.

Officials at Lilly could not be reached for comment.

All of the companies were told to stop using the promotions.

The letters were posted on the FDA website here. (Reporting by Lisa Richwine and Kim Dixon; Editing by Carol Bishopric)

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