Moderna is being audited by the PMCPA after yet again being found to have brought discredit on the pharma industry, putting the company on a path that could lead to its suspension from U.K. trade group the Association of the British Pharmaceutical Industry (ABPI). The latest case identified a “completely unacceptable” lack of transparency by Moderna.
The PMCPA, the self-regulatory body that enforces the ABPI’s code of practice, is auditing the culture, governance and compliance framework at Moderna. The audit was triggered by a complaint about the information Moderna provided in an earlier PMCPA investigation, which ultimately concluded that the biotech discredited the industry with its role in a message that offered children 1,500 pounds sterling ($2,000) to join a trial.
After reading the PMCPA report about the message, campaign group UsForThem filed a complaint about Moderna’s response. During the original investigation, the biotech told the PMCPA it learned about the reimbursement message in January 2024. But UsForThem said it exchanged letters with Moderna about the topic in August 2023.
UsForThem said it told Moderna in August 2023 that “we have been led to understand that at least one of the U.K. medical centers involved in Moderna’s trial has offered to pay a lump sum of £1,500 to each child at the completion of the trial.” At the time, Moderna told the campaign group that the claim was incorrect.
UsForThem told the PMCPA its exchange with Moderna contradicts the timeline the biotech presented in the original investigation. When the PMCPA put the latest complaint to Moderna, the biotech “strongly” disagreed with the allegations, reiterating its claim that it only learned about the message in 2024.
The PMCPA took a different view, telling Moderna that its apparent failure to investigate UsForThem’s claim about a U.K. medical center offering money amounted to a failure to maintain high standards and that the lack of transparency brought discredit on the industry.
In response, Moderna outlined the corrective actions it has taken to improve its compliance framework. But, with the self-regulatory body investigating nine complaints and making five discredit rulings since Moderna joined the ABPI in January 2023, the PMCPA’s appeal board concluded the biotech needs to undergo an audit.
PMCPA audits can lead to further actions, such as additional audits and the requirement for a company’s materials to undergo vetting before use. The appeal board can also report a company to the ABPI board, which has the power to suspend or expel members from the trade group. Suspensions are rare, with the two-year exile of Novo Nordisk marking only the eighth time the board had issued the sanction in 40 years.