A few months after SK Life Science began rolling out a road trip-themed TV commercial for its antiseizure medication Xcopri, the FDA is attempting to put the brakes on the ad.
The regulator late last week posted an untitled letter (PDF) that it sent to the Korean pharma on Sept. 30, in which it accused the commercial of being “false or misleading.”
The minute-long ad showed a man sitting in the passenger seat on a car ride that was slowed, stopped and rerouted by sharply curving roads, fallen trees and mud—meant to represent the “long and winding” path that many people with partial-onset seizures may experience while searching for an effective way to reduce their occurrence.
The FDA cited in its letter to SK several issues with the risk and benefit information presented about Xcopri in the ad. For one, the regulator noted that the TV spot “completely omits” a warning about potential liver injury that’s included in Xcopri’s label.
The regulator also suggested that the warnings that included warnings didn't go far enough in describing potential risks. The FDA pointed to a mention of possible “problems with the heart” in the ad that it said “does not mitigate the misleading impression” created by failing to mention that the drug’s possible side effects include problems with the electrical system of the heart, specifically.
Finally, the agency also took issue with disparities between the drug information described in the “major statement” voiceover and presented in the onscreen text known as “supers.” According to the FDA, multiple pieces of information about Xcopri were provided only either visually or auditorily, leading it to conclude that “the TV ad is misleading because it fails to present the major statement concurrently using both audio and text,” as required by its rule on “dual modality” in direct-to-consumer drug ads.
The FDA gave SK 15 working days to respond to the late September letter; the ad’s YouTube link appears to have been deactivated at some point prior to the FDA’s public posting of the letter last week.
SK did not immediately respond to Fierce Pharma Marketing’s request for comment.
Elsewhere, the FDA posted another Sept. 30 untitled letter (PDF) last week, taking aim at a page on PharmaTher’s website that it said “fails to communicate any risk information” about a recently approved ketamine hydrochloride injection, KetaRx.
The webpage is no longer available, as PharmaTher told Fierce that it had sold the Abbreviated New Drug Application for KetaRx to Caplin Point Laboratories before receiving the FDA letter, and “the corresponding webpage was subsequently removed to reflect this transaction.”
The company added, “We understand that the matters referenced in the FDA letter have been taken care of and that the FDA has not requested anything else.”