In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’ treatment for partial seizures can be used for all seizure types, while downplaying the risks associated with the drug.
The FDA’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Rockville, Maryland-based Supernus Pharmaceuticals on Oct. 31, 2016, after a key opinion leader Spanish video was flagged for making false and misleading representations about Oxtellar XR, an adjunct therapy approved for partial seizures.
The OPDP found the video misbrands the drug and provides a misleading impression about its safety and efficacy, making its distribution a violation of the Federal Food, Drug, and Cosmetic Act. The video also provides evidence that the drug is intended for an unapproved use for which labeling does not provide proper directions for use.
The office took issue with a doctor in the video stating that he often used the medication in combination with other treatments when epilepsy is not controlled and suggesting that the drug has helped improve the level of convulsive control. According to officials, using the general terms “epilepsy” and “convulsive” leaves an impression the drug is intended for use in treating epilepsy, including seizures not defined as partial. Although the proper indication is included in scrolling text following the doctor’s presentation, the OPDP said this doesn’t negate the doctor’s statements. Officials also raised concerns about the doctor’s testimonials representing the drug as safe and effective for the treatment of all seizure types, though no evidence has been provided to support such a claim.
Officials also flagged the video’s failure to properly represent risk. In the opening segment, the doctor makes claims related to the drug’s benefits, but fails to disclose risks associated with the drug. While the risks are described in rolling text with a voiceover at the end of the video, the overall presentation is misleading because it fails to convey risks with a prominence comparable to that of the efficacy statements. Given the drug’s association with several serious, possibly life-threatening risks, the OPDP said the video’s representation is particularly problematic from a public health perspective.
The warning letter calls on Supernus to provide a list of all promotional materials for the drug that contain such violations, along with a plan for discontinuing the use of the materials.