Shire promotional magnet attracts FDA wrath
pharmafile | May 20, 2011 | News story | Medical Communications, Sales and Marketing | FDA, Shire
The use of a promotional magnet by marketers at Shire has attracted trouble from the FDA.
The magnet, which is part of the company’s marketing materials for its attention-deficit hyperactivity disorder drug Vyvanse, was criticised by the US regulator for focusing on the good points of the drug and omitting its side effects.
The FDA’s warning letter notes Vyvanse (lisdexamfetamine dimesylate) is associated with a number of serious risks, some of which are fatal, and its prescribing information includes a warning about the drug’s potential for abuse.
Photographs, submitted as part of the regulator’s new ‘Bad Ad’ complaint system, show the magnet used in a paediatric medical office.
It contained a Shire sales representative’s business card and showed some risk information for the drug, but the FDA said this was not enough and failed to include important information regarding special diagnostic considerations, the need for comprehensive treatment, and long-term use.
As a result, the regulator said the “totality of this presentation misleadingly suggests that Vyvanse is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience”.
Shire must now immediately cease the distribution of any similar promotional materials for Vyvanse.
The UK-headquartered specialty pharma company must also submit a written response to these issues by the end of the week, and say whether it intends to comply with this request.
The FDA also asked Shire to provide a list of all promotional materials for Vyvanse that could also be in breach.
The letter said that because of the seriousness of the breach, Shire must show the regulator a comprehensive plan of action to distribute ‘truthful, non-misleading, and complete corrective messages’ about the issues discussed to anyone who may have seen them.
Failure to correct the violation discussed above may result in FDA regulatory action, including seizure or injunction, without further notice, the regulator added.
Ben Adams
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