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FDA Says Shire, Eisai Drug Promotions Misleading

Nov 17, 2009 | Parker Waichman LLP News media are reporting that the U.S. Food and Drug Administration (FDA) has issued warning letters to Shire PLC and Eisai Co Ltd about drug promotions for Dacogen and Fosrenol. The warning letters state that the Dacogen (Eisai) and Fosrenol (Shire) promotions understate the risk and overstate the benefits of the medications.

The FDA said that a customer-intended promotional card created by Eisai "presents numerous claims that misleadingly overstate the efficacy" of Dacogen, reported Reuters. Dacogen is a medication used in the treatment of the blood disorders myelodysplastic syndromes. The letter, dated November 6, also stated that Eisai’s campaign "omits material risks associated with Dacogen treatment."

According to the FDA, the promotional card was, among other violations, “misleading because it omits and minimizes important risks associated with the use of Dacogen, overstates the efficacy of Dacogen, and omits material facts about Dacogen.” Because of this, said the FDA, “the card misbrands the drug in violation of the Federal Food, Drug and Cosmetic Act.” The FDA went on to explain that, “promotional materials are misleading if they suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience,” and cited examples in which this was done on the card.

The FDA also stated that, “promotional materials are misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.” In just one of the cited examples, the agency said that the “12-page Patient Profile Card” presents claims about the drug’s efficacy prominently, utilizing large lettering and colorful graphics” in the initial pages, and “relegated … limited risk disclosure” information “to the middle of the back cover” in “small font type and single spaced paragraph format.”

In the warning letter sent on November 5 to Shire, the FDA said a Shire brochure for Fosrenol, a chewable tablet kidney medication—among other violations—omitted information on the medication’s risks and also included “unsubstantiated claims” that Fosrenol was more efficacious than its rival medications, reported Reuters.

According to the agency, Shire listed a number of the medication’s benefits; however, said the FDA, its “brochure fails to communicate any of the risk information associated with Fosrenol, including the numerous precautions and adverse reactions listed in the Background section above.” The FDA also cited another example in which it found that Shire’s presentation of Fosrenol “is more effective than other” medications of its kind, but that it is “not aware of any substantial evidence or substantial clinical experience to support” Shire’s implications.

Shire was also cited for suggesting its medication was “useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience,” which the agency said the brochure did in terms of Fosrenol’s use in treating hyperphosphatemia.

Both companies were asked to “immediately cease the dissemination of violative promotional materials” and respond back to the agency in writing by November 20.

A listing of FDA warning letters for 2009 can be accessed at:

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