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 <"http://www.yourlawyer.com/practice_areas/defective_drugs">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 Eisaiâ€™s campaign “omits material risks associated with Dacogen treatment.”
According to the FDA, the promotional card was, among other violations, â€œmisleading because it omits and minimizes important risks associated with the use of Dacogen, overstates the efficacy of Dacogen, and omits material facts about Dacogen.â€ Because of this, said the FDA, â€œthe card misbrands the drug in violation of the Federal Food, Drug and Cosmetic Act.â€ The FDA went on to explain that, â€œpromotional materials are misleading if they suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience,â€ and cited examples in which this was done on the card.
The FDA also stated that, â€œpromotional 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.â€ In just one of the cited examples, the agency said that the â€œ12-page Patient Profile Cardâ€ presents claims about the drugâ€™s efficacy prominently, utilizing large lettering and colorful graphicsâ€ in the initial pages, and â€œrelegated â€¦ limited risk disclosureâ€ information â€œto the middle of the back coverâ€ in â€œsmall font type and single spaced paragraph format.â€
In the warning letter sent on November 5 to Shire, the FDA said a Shire brochure for Fosrenol, a chewable tablet kidney medicationâ€”among other violationsâ€”omitted information on the medicationâ€™s risks and also included â€œunsubstantiated claimsâ€ that Fosrenol was more efficacious than its rival medications, reported Reuters.
According to the agency, Shire listed a number of the medicationâ€™s benefits; however, said the FDA, its â€œbrochure fails to communicate any of the risk information associated with Fosrenol, including the numerous precautions and adverse reactions listed in the Background section above.â€ The FDA also cited another example in which it found that Shireâ€™s presentation of Fosrenol â€œis more effective than otherâ€ medications of its kind, but that it is â€œnot aware of any substantial evidence or substantial clinical experience to supportâ€ Shireâ€™s implications.
Shire was also cited for suggesting its medication was â€œuseful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience,â€ which the agency said the brochure did in terms of Fosrenolâ€™s use in treating hyperphosphatemia.
Both companies were asked to â€œimmediately cease the dissemination of violative promotional materialsâ€ and respond back to the agency in writing by November 20.
A listing of FDA warning letters for 2009 can be accessed at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773