A television ad campaign for the cholesterol-lowering drug fluvastatin (Lescol) contained false and misleading information, according to a letter released Tuesday by the Food and Drug Administration (FDA).
The ads claimed that Lescol was as effective as three other cholesterol-reducing drugs: Pravachol, Mevacor, and Zocor. However, the manufacturer, Novartis Pharmaceuticals, did not provide any substantiation of those claims and has not done any head-to-head studies, according to Minnie Baylor-Henry, director of FDA's Office of Drug Marketing, Advertising and Communications.
The company also advertised Lescol as less expensive than other drugs -- a misleading claim, according to the FDA.
The ads ran in August, September, and October in Baltimore, Atlanta, St. Louis and Tampa, and the FDA asked Novartis to immediately submit a plan for undoing the damage it had done.
The federal agency is only now warning the company because it was not aware of the ads until they had finished running. Pharmaceutical manufacturers are supposed to submit advertising text, audio, or video to the FDA at the time it is first displayed or broadcast, but Novartis did not do so.
That resulted in "a significantly larger consumer audience receiving false or misleading information about the safety and effectiveness of Lescol," wrote Baylor-Henry.
Novartis advertised Lescol as costing up to 60% less than other cholesterol medications, but the company did not mention that there may be additional costs incurred for lab tests and office visits, both needed to help determine correct dosing, said the agency.
The company also did not use equivalent dosages. "In fact, because of dosing differences, Lescol may cost more than the other agents," according to the FDA.
Novartis' ads minimized risks of liver function abnormalities, and did not give patients enough information on how to learn more about side effects and other risks, the FDA said.
The campaign was a "pilot" and was last run in October, according to Anna Frable, a spokesperson for Novartis. The company "is currently reviewing the letter and we do absolutely plan on responding to the agency by their deadline," Frable said.
By February 5th, the FDA wants a complete list of TV stations that broadcast the ads, and the number of times aired. And the agency indicates that Novartis should design new ads, including, but not limited to, print ads, that "disseminate accurate and complete information to the audience that received the misleading message."
The company may even have to run new TV ads. "We think it's important to use comparable methods to reach the same audience," FDA drug advertising specialist Norm Drezin told Reuters Health.
The ads claimed that Lescol was as effective as three other cholesterol-reducing drugs: Pravachol, Mevacor, and Zocor. However, the manufacturer, Novartis Pharmaceuticals, did not provide any substantiation of those claims and has not done any head-to-head studies, according to Minnie Baylor-Henry, director of FDA's Office of Drug Marketing, Advertising and Communications.
The company also advertised Lescol as less expensive than other drugs -- a misleading claim, according to the FDA.
The ads ran in August, September, and October in Baltimore, Atlanta, St. Louis and Tampa, and the FDA asked Novartis to immediately submit a plan for undoing the damage it had done.
The federal agency is only now warning the company because it was not aware of the ads until they had finished running. Pharmaceutical manufacturers are supposed to submit advertising text, audio, or video to the FDA at the time it is first displayed or broadcast, but Novartis did not do so.
That resulted in "a significantly larger consumer audience receiving false or misleading information about the safety and effectiveness of Lescol," wrote Baylor-Henry.
Novartis advertised Lescol as costing up to 60% less than other cholesterol medications, but the company did not mention that there may be additional costs incurred for lab tests and office visits, both needed to help determine correct dosing, said the agency.
The company also did not use equivalent dosages. "In fact, because of dosing differences, Lescol may cost more than the other agents," according to the FDA.
Novartis' ads minimized risks of liver function abnormalities, and did not give patients enough information on how to learn more about side effects and other risks, the FDA said.
The campaign was a "pilot" and was last run in October, according to Anna Frable, a spokesperson for Novartis. The company "is currently reviewing the letter and we do absolutely plan on responding to the agency by their deadline," Frable said.
By February 5th, the FDA wants a complete list of TV stations that broadcast the ads, and the number of times aired. And the agency indicates that Novartis should design new ads, including, but not limited to, print ads, that "disseminate accurate and complete information to the audience that received the misleading message."
The company may even have to run new TV ads. "We think it's important to use comparable methods to reach the same audience," FDA drug advertising specialist Norm Drezin told Reuters Health.
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