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#Pharma Cites 1st Amendment to Oppose FDA's Study of Animated "Mascots" in Drug Ads

#Pharma Cites 1st Amendment to Oppose FDA's Study of Animated "Mascots" in Drug Ads | Pharma Industry Regulation |

The National Advertising Coalition, a lobbying group, wrote that the FDA's proposal to study animations “must ensure that [its] regulations adhere to the First Amendment.” The First Amendment has become a common refrain for advertising lobbying groups defending advertising. In May, Amarin sued the FDA saying the regulator violated its First Amendment rights by limiting its ability to legally communicate benefits of its fish oil pill Vascepa. A court later ruled in Amarin's favor. Another drugmaker, Pacira Pharmaceuticals, sued the FDA saying that the agency's 2014 warning letter regarding its marketing of painkiller Exparel illegally narrowed its label. The FDA ultimately settled with Pacira, allowing the drugmaker to market Exparel beyond its original labeling.  

The Coalition also cited Zauderer v. Office of Disciplinary Counsel, a case in which the Supreme Court ruled against the State of Ohio's argument that “pictures or illustrations in connection with advertising...may under some circumstances be deceptive or manipulative.”

AstraZeneca, too, offered its thoughts on the proposed animation study, offering feedback on some of the information the agency seeks to collect. The FDA has defined animated characters broadly. The agency includes any kind of animated characters that symbolize the disease, the benefit, the mode of administration, and the mechanism of action.

The drugmaker said that one question, which asked test takers to list how a drug ad made them feel, “could generate a testing bias that may affect the results,” Cheryl Jones, the drugmaker's associate director of promotional regulatory affairs, wrote in the comment letter. Jones added that deciding whether an ad is ethical “is not an appropriate metric for demonstrating the relative trust or lack thereof of in the ad.” The British drugmaker used animation techniques in its award-winning campaign, “Take it from a fish.”

Pharma Guy's insight:

LOL! Is it necessary to bring the first amendment into this? Anyhoo! For a more humorous take on of drug mascots, see my "Gallery of Drug Advertising Mascots"; 

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