FDA Cites Novartis Tasigna Facebook Promo

Drug maker <"http://www.yourlawyer.com/practice_areas/defective_drugs">Novartis was just issued a warning by the U.S. Food and Drug Administration (FDA) for how it marketed a specific drug on social media giant, Facebook, wrote Bloomberg Business Week.

The FDA warned Nonartis that how it is using Facebook’s Share button to market information about the cancer-fighting drug, Tasigna, violates FDA requirements for how to disclose drug information, said Bloomberg Business Week. The letter, sent to Novartis Pharmaceuticals on July 29, advised that use of Facebook Share, in this case, is both incomplete and misleading. According to Jeffrey Chester, a privacy advocate and executive director of the Center for Digital Democracy, this might be the first time the agency has had to issue a warning to a drug maker for its use of Facebook for marketing, according to Bloomberg Business Week.

The letter asks Novartis to cease using Facebook’s Share option to market the leukemia drug, reported Bloomberg Business Week. The letter appears on the FDA’s website.

“The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug,” said the FDA letter, signed by Karen Rulli, acting group letter of the agency’s Division of Drug Marketing, Advertising, and Communications. “In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products,” Rulli wrote, quoted Bloomberg Business Week.

FDA mandates that medication promotional pieces generally contain information about drug risks, according to the letter, which also stated that such materials are misleading if they suggest a “drug is safer or more effective than another drug when this superiority has not been demonstrated by substantial evidence or substantial clinical experience,” wrote the FDA, quoted Bloomberg Business News. The letter pointed out that Novartis did not notify the FDA of the Tasigna promotion, an agency requirement.

We recently wrote about other Novartis trouble in which Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation agreed to a $72.5 million payout to settle civil False Claims Act allegations originating with the marketing of cystic fibrosis drug TOBI, said the Justice Department. The settlement resolved allegations that, between January 1, 2001 and July 31, 2006, Novartis and its predecessor, Chiron Corporation, caused false claims to be submitted to federal health care programs for certain off-label uses of the inhaled antibiotic which was approved by the FDA for use in certain cystic fibrosis patients.

The United States alleged that Chiron, and later, Novartis, marketed TOBI for unapproved, or off label, uses for diseases other than cystic fibrosis, as well as for cystic fibrosis patients not meeting criteria for the FDA-approved indication, and for uses for which TOBI was not a medically accepted. According to the government, it alleged these actions resulted in false claims to federal health care programs.

The current FDA warning letter points to issues with websites that seek marketing dollars from Big Pharma, said Chester, who asked the FDA in March to look into online drug marketing wrote Bloomberg Business News. Chester noted that Facebook should create protection medication—and other health products—marketing that appears on it site.

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