GSK has successfully appealed a ruling by the U.K. marketing watchdog that determined a trio of its COVID-19 vaccine press releases had brought discredit on the pharma industry.
The case is the latest in a series of PMCPA investigations into the use of relative efficacy in press releases about clinical trial data for COVID-19 vaccines. Last year, the PMCPA found that a GSK press release had breached the rule against making misleading claims, and GSK said it accepted the findings and sanctions related to the breach.
Later, the original complainant found GSK press releases that similarly quoted relative efficacy were still available online. The discovery led the member of the public to submit a new complaint, accusing GSK of making misleading claims and of failing to comply with the undertakings associated with the previous case.
In that follow-up case, the PMCPA originally ruled that GSK had brought discredit on the industry, the most serious wording in its arsenal, among other violations of the self-regulatory body’s code. The ruling reflected GSK’s failure to move the historical press releases to an archive, with the panel unconvinced by GSK’s argument that managing historical press releases raises complex legal, compliance and regulatory challenges.
GSK proceeded to appeal the ruling. Though the appeal board upheld parts of the original ruling, finding that GSK had indeed breached three clauses related to making misleading and unsubstantiated claims, it ultimately found the company’s argument against its other scoldings compelling.
The appeal against the ruling that GSK had failed to comply with an undertaking imposed in the original case centered on the timing of the second complaint. GSK said the PMCPA provided informal advice in June 2024, which led the British pharma to create an archive for old press releases on its global website.
“However, creating this archive was not an instantaneous process. It required re-engineering of GSK’s website, along with a review of materials for archiving,” the company said. “While GSK acknowledges this step took some weeks, this was not an unrealistic or delayed timeframe, given the complexity of the task.”
GSK received the second complaint in mid-August 2024. The company said the complaint arrived “before the archiving process for press releases could reasonably be completed.” GSK acknowledged the need to implement the changes in a timely manner but argued that it acted “carefully and responsibly in the circumstances.”
The appeal board therefore ruled that GSK had not breached its undertaking, citing the scale of the task at hand and the number of working days between the end of one case and the start of the next to support its conclusions.
From there, overturning that ruling led the appeal board to conclude that GSK had not in fact breached the rule on bringing discredit on the industry.