The charges would appear serious - the FDA says the drugmakers variously omitted material facts; miminized important risks; overstated efficacy or made unsubstantiated claims.
This is the warning letter sent to Shire and some other promotional materials cited; the letter sent to Johnson & Johnson for its Concerta pill and the ad; the letter sent Novartis over its Focalin XR Med slides; the letter sent Mallinckrodt for its Methylin drug ad; and the letter sent to Lilly for its Strattera pill and the offending promotional material.
The drugmakers were contacted by Bloomberg News, which gathered the following comments:
A Shire spokesman wrote the news service that the web posting cited by the FDA "was made in error'' and the drugmaker is "committed to complying with both the letter and the spirit'' of the agency's regulations. The video posting was removed last year, and wasn't intended to appear on its own without additional information on dosing and use, he added.
Lilly is reviewing the letter and "will work with the FDA to address their concerns,'' a spokesman says.
A J&J spokeswoman wrote the news service that the drugmaker "will work closely with the FDA to address the issues raised in its letter.'' A Mallinckrodt spokeswoman tells the news service the drugmaker is "preparing a response to address the FDA's concerns.'' And a Novartis spokeswoman says the drugmaker will respond to the FDA after reviewing the letter.
"Manufacturers will always try to go right to the limit in making their promotional claims to doctors, and doctors tend to follow their claims,'' Larry Diller, a behavioral pediatrician who wrote Running on Ritalin: Should I Medicate My Child? and says ADHD meds are overprescribed, tells Bloomberg. "When claims are overstated, there is both over-prescribing and mis-prescribing and in the end children get hurt."