FDA Snarls At Lilly Ads For New Dog Drug
2 CommentsBy Ed Silverman // July 10th, 2007 // 9:05 am
What was the problem? Lilly’s Elanco Animal Health unit overstated the effectiveness of Reconcile, its new tablet for dogs with separation anxiety. Actually, Reconcile isn’t new; it’s really Prozac for pooches and the drugmaker is marketing the med to owners who fear Fido will act up while the Master is away.
A few months ago, Lilly vet Steve Connell said the beef-flavored chewable tab “basically calms the dog and makes it more receptive to the (behavior management) training that’s supposed to go along with it.†But in promotional pieces and print ads, Elanco improperly played up Reconcile’s effectiveness against a placebo, and forgot to mention that positive study results may have reflected dogs that received Reconcile and ‘behavior modification,’ too.
The violations are misleading and serious, the FDA wrote Elanco, which has been required to send Dear Doctor letters to vets. You can read the agency’s June 26 warning letter to the drugmaker here. This time, Lilly barked up the wrong….well, you know.
John Mack
The FDA might as well smack Lilly across the nose with a newspaper for all the good that this “untitled” — not even warning — letter will do.
I wonder how many doggie DTC ad regulators there are compared to human DTC ad regulators? Will some PDUFA funds go to hiring more of the former as well as the latter?
Laurie
No surprise here. Withholding critical information about a drugs effectivness is normal operating procedure for the pharmaceuticals.