GSK showed a “totally unacceptable” lack of transparency in its interactions with the PMCPA, the U.K. self-regulatory body ruled.
The PMCPA originally investigated whether a GSK video about a shingles vaccination program broke U.K. rules on advertising prescription-only medicines to the public. GSK successfully defended itself against all the allegations. After reaching its conclusions, but before releasing its findings, the PMCPA sent the case report to the U.K. Health Security Agency (UKHSA) as a courtesy because it was named in the document.
That is when the heat on GSK intensified. The UKHSA responded to the PMCPA to suggest that extracts of minutes that GSK cited in its defense failed to accurately reflect its engagement with the drugmaker. After receiving materials from the UKHSA, the PMCPA opened a new case centered on GSK’s disclosures. The second case went against GSK.
“The panel was seriously concerned about GSK’s conduct in [the original case], including its conduct at the appeal board hearing and its failure to provide a full and frank disclosure,” the PMCPA said. “GSK’s lack of transparency, which had only come to light due to [the] UKHSA contacting the PMCPA, was totally unacceptable.”
In an emailed statement, a GSK spokesperson said the company is “committed to upholding the highest standards of integrity and ethical conduct in all aspects of our business, including adherence to industry codes and regulations.” The spokesperson added that GSK supports the principles and requirements of self-regulation, including transparency and the PMCPA’s role, and ran the shingles campaign in good faith.
“With regards to the report’s findings, while there was no intention to mislead the PMCPA, we recognize that greater information and context could have been provided and we regret and apologize for this,” the spokesperson said.
The PMCPA ruled that GSK failed to maintain high standards when providing materials to inform the original case. The rulings centered on whether GSK accurately represented the information it received about the UKHSA’s approval—or lack thereof—of the shingles vaccination awareness campaign.
GSK gave the PMCPA minutes of its meeting with the UKHSA, only cutting, in its words, “unrelated topics and personal identifiers.” When the PMCPA received the full minutes, it saw that GSK had cut a section in which the UKHSA “emphasized the importance of maintaining a professional distance, reflective of the independent nature of each organization.” The PMCPA ruled that GSK erred by cutting the information.
Another PMCPA finding related to an email exchange between GSK and the UKHSA. Four weeks before the PMCPA ruled on the original case, the UKHSA emailed GSK to say that “it is not within our remit to give any formal approvals and we have not provided this function.” The agency added that it was clear from the outset that it “would not be able to endorse” any materials.
GSK never told the PMCPA about the exchange. After finding out about the email, the PMCPA ruled that the company’s nondisclosure represented a failure to maintain high standards. The PMCPA called GSK’s failure to share the email with the appeal board for the original case “grossly misleading.”
Other findings covered GSK’s exchanges with the appeal board handling the original case. GSK told the PMCPA that it “consistently and accurately stated that it had never asserted that [the] UKHSA was providing formal ministerial approval.” The PMCPA panel called GSK’s claim “wholly disingenuous,” citing the drugmaker’s written and verbal statements to support its conclusions.
While GSK expressed regrets to PMCPA about certain aspects of its handling of the original case, it sought to overturn most of the findings on appeal. GSK argued that it selected extracts from the meeting minutes in good faith, and that it did not consider the UKHSA email to represent “a settled or authoritative position.”
GSK found no evidence that the decision not to disclose the UKHSA email was a deliberate attempt to mislead, telling the PMCPA that it needed to investigate the conflict between its understanding and the health agency’s position. The PMCPA appeal board called GSK’s decision “totally unreasonable” and took GSK to task for the actions.
“The appeal board was particularly concerned by the positive decisions made by GSK’s representatives to not provide or refer to crucial correspondence that GSK had had with UKHSA that was unambiguously contradictory to the company’s submissions. To claim confusion for this decision was disingenuous,” the PMCPA said. “The appeal board questioned the culture within GSK in this regard.”
GSK was publicly reprimanded by the PMCPA.