Promotional material for Cephalon’s sleep drug Provigil (modafinil) distributed at a recent public meeting in the USA has come under fire by the Food and Drug Administration.
The agency has taken issue with recommended uses for Provigil in the literature that have not been approved by regulators. A handout dished out by a doctor on the company’s behalf said that the agent is “safe and effective for use in the treatment of various disorders associated with fatigue, sleepiness, or inattentiveness when, in fact, the drug is not indicated for fatigue at all and is indicated only for specific groups of patients with excessiveness sleepiness,” it said.
Furthermore, the FDA was concerned over the lack of information about any risks associated with taking the drug, and that the FDA-approved product labelling did not accompany the promotional piece.
“These violations present serious public health and safety concerns,” the agency states in a warning letter to Cephalon Chief Executive Frank Baldino. The company has until March 12 to respond.
Actiq promotion also questioned
This isn’t the first time the group’s marketing activities have been in the spotlight. Last November, Cephalon was accused of acting unlawfully in its promotional activities for Actiq, a lollipop formulation of the opioid painkiller fentanyl.
The product is indicated for the treatment of breakthrough pain in cancer patients, but state authorities in Connecticut, USA, believe Cephalon has illegally promoted it for off-label use in other conditions requiring pain relief. In the USA, doctor are free to prescribe drugs off-label provided there are legitimate grounds for doing so, but companies are prohibited from promoting such uses.
