FDA Issues Warning to Novartis

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The Food and Drug Administration issued a warning letter to Novartis Corp., East Hanover, NJ, on Jan. 21 ordering the drug company to correct its television advertising campaign for Lescol, a cholesterol-lowering drug.


While the FDA acknowledged that a spot for the drug has stopped running, it instructed Novartis to run a corrective ad "in a manner comparable to the dissemination" of the ads that are in violation of the administration's guidelines. Novartis would not comment on the letter except to say that it intended to respond before the Feb. 5 deadline imposed by the FDA.


The FDA complains that the Novartis ad is misleading in its claim that Lescol is similar in effectiveness to the cholesterol-lowering drugs Pravachol, Mevacor and Zocor, but is less expensive. The FDA contends that this claim oversimplifies a comparison with competing drugs.


"In adequate and well-controlled clinical trials, some of these 'other cholesterol agents' have demonstrated additional benefits in the treatment of cardiovascular morbidity and mortality," according to the author of the complaint, Minnie Baylor-Henry, director of the FDA's division of drug marketing, advertising and communications. "Novartis has not demonstrated that Lescol provides any of these benefits nor that Lescol is comparable in effectiveness to these other agents for its indicated uses."


The FDA says that the company's claim that Lescol is 60 percent less expensive than other drugs is particularly flawed.


"Patients already taking another cholesterol lowering drug are not likely to understand that they need a different dose of Lescol in order to attain the same effect, and that this difference may reduce any potential savings," Baylor-Henry said.


The FDA says the advertisement is also misleading because it minimizes risks associated with the use of Lescol. The labeling on the product says that liver function tests be performed before the initiation of therapy, and 6 and 12 weeks after taking Lescol or after the dosage is increased.


"Novartis minimizes the significance of this important risk information by failing to state why such tests are recommended, i.e. because Lescol can cause liver problems," said Baylor-Henry.


She advised that the labeling include a statement that notifies patients to tell their doctors of other medications they are taking. It should also include a statement about any side effects, however mild, because a complaint of muscle weakness could be signs of more serious problems.


The company is also charged with providing insufficient information in the ad's brief summary about side effects and contraindications. This is in violation of a federal code which states that all pharmaceutical television ads must have a method of disseminating information on side effects and contraindications if the information is not included in the ad itself. The FDA alleges that Novartis did not adhere to this provision.


"The focus of this provision is on the dissemination of risk information, not coupons or discount certificates," said Baylor-Henry. "However in this ad, reference to the 800 number only specifically addresses the availability of a rebate coupon, and the reference to the Web site and the concurrently running print ad are of insufficient prominence and duration to be read and processed by viewers. Additionally the statement 'ask your doctor if Lescol is right for you' is insufficient to communicate that the physician or health care professional is a source of additional information about Lescol."


This is not the first time a pharmaceutical company has had to change its ad. In August 1997, 11 days after the FDA issued its Guidelines to Industry on pharmaceutical advertising, the FDA sent a similar to letter to Schering Corp., Kenilworth, NJ, criticizing two of its Claritin ads, which have since been discontinued.


In that instance, the FDA said the risk information, which was part of the major statement, was not disclosed in the same way as the drug use information.


"The drug use information is presented clearly and slowly," that letter said. "In contrast, while the major statement information concerning the most common side effects is being presented in the audio part of the advertisement, there is a competing message being disclosed simultaneously. These competing messages coming from different modalities virtually ensure that consumers will have trouble comprehending fully any of the messages."


The company was also criticized for disclosing other sources of information on the drug in an obscure manner. The statement "See our ad in Newsweek" was printed in white letters on a white background.


As part of the guidelines the FDA issued in 1997, there is a provision for pharmaceutical companies to voluntarily submit their ads to the FDA for a preview so any corrections that have to be made can be made before the ad is rolled out. The administration does not have the authority to require companies to submit ads, but leaves it open as an option.


"The best thing marketers can do is follow the guidelines," said Frank Hone, executive vice president and management director for Rubin Ehrenthal & Associates, a healthcare ad agency in New York. "Some companies take advantage of the FDA's offer to preview ads, many more don't. The FDA is going to be strong on its stance to correct this kind of situation."
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