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WASHINGTON, Sept 26 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
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,"
Novartis is reviewing the FDA letter and will
respond to the agency, company spokeswoman Pamela McKinlay
Officials at Lilly could not be reached for comment.
All of the companies were told to stop using the
The letters were posted on the FDA website here.
(Reporting by Lisa Richwine and Kim Dixon; Editing by Carol