Article Reprinted from "The Pink Sheet" May 26, 2009
FDA's aggressive enforcement of its advertising standards, and the agency's new enforcement allies, mean that industry may now have more to fear from a citation letter.
"We applaud the new aggressiveness by DDMAC, and as a result, we have more opportunities for synergies working with the federal government," Oregon Assistant Attorney General David Hart said during a May 20 webinar sponsored by Elsevier Business Intelligence. Read on...
Article Reprinted from "The Pink Sheet" May 26, 2009
Three letters released by FDA on May 19 help illustrate the new enforcement landscape. The citations did not break any new ground in terms of the agency's standards for risk disclosure, but they did serve as a milestone of sorts. With those letters, the agency's Division of Marketing, Advertising and Communications has now issued more citations so far this year than it did in all of 2008.
Of course, the 2009 tally was boosted by the 14 letters related to sponsored search terms on the Internet. But the 2008 count itself was buoyed by a batch of letters targeting drugs for attention deficit disorder, suggesting that bulk citations may be an emerging enforcement trend.
The most recent round of letters made two key points:
Don't put all your risk information at the end of the ad
Don't make any claim - even something like you sleep better when you are not in pain - if it's not on the label.
Dexcel Pharma, Cornerstone Therapeutics and Johnson & Johnson learned those lessons the hard way.
The good news for firms looking to avoid a similar fate is that the restrictions FDA is emphasizing aren't new; firms just might not have heard them in a while. And the agency's new enforcement focus means that firms could have less fear that a competitor might gain an advantage if they themselves pull back from aggressive promotions, because the competitor would presumably also be cited.
But for the firms that are cited, the picture looks dimmer. While traditionally citation letters brought some unfavorable attention, especially from the plaintiffs bar, now a letter could mean a date in court with the state consumer protection bureau.
Hart cited the example of a corrective advertising campaign that Bayer recently conducted for its oral contraceptive Yaz.
A previous settlement with Bayer related to Baycol had given state attorneys general "the authority basically to enforce" the Food Drug and Cosmetics Act.
So when Yaz DTC ads received an FDA warning letter, "not only did we have the concerns that we might have regarding the violation of state law, but we had FDA's interpretation that [the ads] violated the FDCA and thus violated our consent judgment, so we had a potential action for contempt of court, and we also had the potential action for violation of our consumer protection law."
"Those were two pretty big sticks," Hart noted.
"Our understanding from our friends at FDA ... was that we provided additional leverage and that additional leverage was instrumental in terms of" producing an "effective corrective advertising program that was broader than would have been achieved by FDA alone. That was FDA's perspective."
"The days of pushing the envelope are perhaps in the past," Hart said. That vision and enforcement power have led some to conclude that states may present a "super FDA".
McDermott Will & Emery attorney Arnold Friede agreed. "The stakes on getting a warning letter are much, much higher than people perceived them to be in the past," he said during the webinar. Friede is working to organize an industry coalition to present FDA with an alternate framework for regulating internet promotions.
Yaz was among the products cited in FDA's sweep of sponsored search terms, but Hart declined to comment on what actions the states might take as a result of this most recent citation.
Hart did note that there are likely to be more products soon in state's cross hairs. Pfizer and Merck have existing consent decrees, and "Pfizer is soon to gobble up Wyeth; Merck is about to gobble up Schering-Plough, and now all those terms will apply" to the combined firms, he said.
- M. Nielsen Hobbs
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