The FDA Division of Drug Marketing, Advertising, and Communications has issued one of its increasingly rare enforcement letters, calling Eli Lilly (NYSE:LLY) to task for overstating the efficacy of its drug Cymbalta in a "professional mailer" sent to physicians. The letter said:
This mailer is false or misleading in that it overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use. Therefore, the mailer misbrands the drug in violation of Sections 502(a) and 201(n) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. 352(a) and 321(n), and FDA implementing regulations.
Sending so-called "untitled" letters, like this one, and the theoretically more serious "warning letters" have traditionally been the FDA's only power to do anything deceptive drug advertisements and promotional materials. Under the FDA Amendments Act of 2007 recently signed by President Bush, the FDA has gained the power to impose monetary "civil penalties" for violations of the regulations concerned drug ads -- up to $250,000 per violation, ("up to" being the operative words here) maxing out at $500,000 for a single company in a three year period. Arguably these fines, if the FDA ever actually musters up the gumption to impose them, are a slap on the wrist.
But will the FDA use them? The FDA's number of enforcement letters has dwindled to a trickle over the past 8 years. This year, letters have hit an all-time low: While the FDA has issued 14 letters so far in 2007 concerning promotions to physicians, here's how many they've issued to drug companies regarding direct-to-consumer ads:
One!
That was a slap on the wrist for Takeda Pharmaceutical's ad for the sleep aid Rozerem -- and even calling it a slap on the wrist is perhaps overstating it -- the ad had a "back to school" theme (i.e. August/September) - and the FDA's letter was issued in March!
Perhaps the fees that the FDA is now able to collect from drug companies for reviewing drug ads (a power also gained under the recently-enact FDA Amendments Act) will permit the FDA to hire more advertisement reviewers (right now they are woefully understaffed, given the 50,000+ promotional materials filed with the FDA every year). That in and of itself will not mean that the FDA will use its new powers... Only political will can do that, and so far there's precious little evidence of that at the FDA...
Here's the FDA's letter: Here's the promotional mailer they were concerned about.
Hat tip: Forbes
P.S. The mailer asked Physicians receiving it to fill it out a survey -- in exchange for which they'd receive this handsome simulated leather letter tray! Classy... And oh so "practice related."
