May 17th, 2011
FDA Issues Shire Warning Letter On ADHD Drug Marketing
The Wall Street Journal
The Food and Drug Administration issued Shire PLC (SHPGY, SPH.LN) a warning letter about promotional material involving the company’s attention-deficit disorder drug Vyvanse.
The May 6 warning letter was posted to the agency’s website on Tuesday. The letter said a promotional material sent to a doctor’s office failed to “adequately disclose risk information” about the product. The letter also said the material didn’t fully communicate the full indication for the drug as an attention deficit hyperactivity disorder, or ADHD, treatment.
The agency said it reviewed photographs of the material, which was submitted to it as part of a “bad ad” complaint program. The promotional material involved a magnet showing Vyvanse and images of different dosage strengths. A Shire sales representatives business card was also included with the magnet in a clear plastic sleeve. The FDA said the business card covered the majority of the risk information that was printed on the magnet.