Moderna and Novo Nordisk are once again in the bad books of the U.K.’s drug marketing watchdog. The repeat offenders received their latest dressing-downs over a gathering of healthcare professionals and problems with the disclosure of transfers of value, respectively.
Novo has repeatedly attracted the ire of the Prescription Medicines Code of Practice Authority (PMCPA) in recent years, earning it a suspension from the Association of the British Pharmaceutical Industry (ABPI) and a series of admonishments for “bringing discredit on the industry.” Meanwhile, the PMCPA twice found Moderna had brought discredit on the industry in a matter of days last year.
The latest PMCPA cases yet again accused the companies of bringing discredit on the industry, as indicated by findings of breaches of the ABPI Code of Practice’s Clause 2.
Novo’s case is part of a series of assessments of its problems recording transfers of value to health professionals.
A PMCPA investigation into earlier allegations, which largely sided with Novo, led researchers from the University of Bath and Lund University to dig into the company’s reporting. In parallel, Novo conducted its own investigation after its response to another complaint uncovered problems. Novo reported itself to the PMCPA in 2023, leading to another accusation that it had brought discredit to the industry.
The latest PMCPA report covers the findings of the Bath and Lund academics. Novo noted a significant overlap between the academics’ findings and its voluntary admission. Even so, the PMCPA panel ruled Novo discredited the industry by failing to disclose payments and misreporting payments to healthcare and patient organizations over an extended period of time.
The academics delivered the verdict Monday.
“It’s deeply concerning that so many errors from the past three years weren’t picked up in Novo Nordisk’s own review,” the University of Bath’s Emily Rickard said in a statement. “This happened while the company was under audit—a time when compliance should have been a top priority.”
Moderna’s case centered on a 2023 meeting attended by 56 healthcare professionals from 20 countries to discuss COVID-19 and respiratory syncytial virus (RSV). The company called the event a global advisory board meeting, but the PMCPA panel questioned that view, querying the ratio of employees to experts and the split between time for presentations and discussions.
“Taking all factors into account, including the outputs of the meeting which lacked national differences, along with the number of staff and participants, the panel did not consider that the arrangements were such that the U.K. health professional had attended a genuine advisory board meeting,” the PMCPA said.
Referring to the biotech’s RSV vaccine, the panel said, “Moderna had, in effect, made a payment to a U.K. health professional to attend a promotional meeting which detailed an investigational product which at the time did not have marketing authorization.” The appeal board said it was “very concerned about the arrangements for the meeting” and asked Moderna to respond.
Moderna outlined steps it has taken to address the panel’s concerns and avoided additional sanctions. The appeal board spared the biotech after recognizing it “was a new and rapidly growing organization which had recently joined the ABPI.”