Banner triggers OPDP letter to Oak Pharmaceuticals
An Oak Pharmaceuticals booth at the American Society of Health-System Pharmacists meeting in December caught the attention of two officials from the FDA's Office of Prescription Drug Promotion, triggering an untitled letter about risk claims.
The letter, published in May by the FDA, said the firm's banner at the meeting for the anticonvulsant Nembutal was misleading because it did not include any risk information. OPDP wrote that this omission gave the impression that the drug is safer than it is.
OPDP said that text that ran along the bottom of the banner directing visitors to “see booth representative for full prescribing information and important safety information” did not compensate for the omission.