FDA issues Cephalon warning letter over Provigil marketing materials
The FDA has warned Cephalon that promotional materials for its sleep drug Provigil made misleading claims the drug could also treat fatigue.
The promotional materials also did not include information about the drug’s risks, the FDA said in a warning letter sent to Cephalon and posted to the agency’s Web site late last week.
The marketing materials were disseminated on behalf of Cephalon to the Maryland Department of Health and Mental Hygiene’s Pharmacy and Therapeutics Committee during a meeting on Aug. 17, 2006.
“Cephalon failed to submit the piece to FDA,” the letter stated. “These violations present serious public health and safety concerns.”
Cephalon has investigated the matter and plans to respond to the warning letter, spokeswoman Sheryl Williams told MM&M.
Williams said responsibility for the materials is shared between Cephalon and Dr. Harry Kerasidis, who was speaking at the meeting on the drug maker’s behalf.
“I’m not really sure whether the doctor, in his enthusiasm, just did not think about what he was doing, or whether the person who set up the meeting didn’t properly inform the doctor. I don’t have that level of detail. But we certainly know the system broke down,” Williams said.
“There is one message we want to be sure that everyone understands,” she added. “We are in agreement with the FDA with the egregious nature of the document. That’s important to us.”
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