Regulatory Focus™ > News Articles > FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments

FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments

Posted 04 November 2016 | By Zachary Brennan 

FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine).

The letter, the fifth of which was issued this year by OPDP (the last one was issued in September), focuses on the video’s use of the general terms “epilepsy” and “convulsive” in discussing the drug, which the office says suggests that Oxtellar XR is intended for use in treating epilepsy, including seizure types other than partial seizures.

“However, as described in the INDICATIONS AND USAGE section of the PI, ‘Oxtellar XR is indicated as adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age.’ Therefore, the video presentation provides evidence that Oxtellar XR is intended for use in treating all seizure types, which is a use for which it lacks approval and for which its labeling does not provide adequate directions,” the letter reads.

FDA said it acknowledges that the correct indication appears following the presentation in scrolling text and a voiceover, though that does not negate the earlier statements.

The presentation “misleadingly suggests” that Oxtellar XR is approved for the treatment of all seizures, when this is not the case, FDA adds, noting that the suggestion that Oxtellar is safe and effective for the treatment of seizures other than partial seizures has not been supported.

The letter also highlights the opening segment of the video’s failure to disclose any specific risks associated with the drug.

“As described in the WARNINGS AND PRECAUTIONS section of the PI, Oxtellar XR is associated with several serious, potentially life-threatening risks and numerous adverse reactions. The presentation of risks associated with Oxtellar XR is relegated to the end of the video after Dr. Piña-Garza’s presentation, where it is unlikely to draw the viewer’s attention, as it is displayed in scrolling text with a voiceover.”

Supernus has yet to respond to a request for comment, and has until 14 November to respond to FDA.

OPDP Letter

Materials


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