A U.K. marketing watchdog has reprimanded Sanofi for using “a highly misleading interpretation of data” to make disparaging claims about Pfizer’s respiratory syncytial virus (RSV) vaccine.
The PMCPA, the self-regulatory body that oversees drug marketing in the U.K., took Sanofi to task over three cases brought by Pfizer. One case, details of which were published in February, related to quotes attributed to Paul Hudson, then Sanofi’s CEO, in a U.K. newspaper. After complaining about the article to the PMCPA, Pfizer filed subsequent complaints about two other news stories and a Sanofi press release.
In all three cases, the PMCPA found Sanofi had brought discredit upon, and reduced confidence in, the pharmaceutical industry. The censure, the harshest in the PMCPA’s arsenal, led the watchdog to publicly reprimand Sanofi and run adverts publicizing the company’s wrongdoing.
Sanofi could face further sanctions. The PMCPA discussed whether to audit Sanofi but opted to defer its decision on potential further sanctions until after its appeal board meets in October. The watchdog has told Sanofi to send a senior representative to the meeting.
The company escaped the immediate imposition of a PMCPA audit after telling the watchdog that it had arranged a third-party review of its operations for June and July. The PMCPA expects Sanofi to provide a copy of the third-party audit report and share details of actions it has taken, and is taking, in response to the findings.
At a minimum, the PMCPA expects the third-party report to cover Sanofi’s culture, compliance program, adherence to the U.K. marketing code and implementation of standard operating practices. Sanofi told the PMCPA that the issues exposed by its comments in the Sunday Express, Health Service Journal and two social media posts were limited to one business unit and a short period of time.
There has been a significant change in leadership personnel since Pfizer complained about the materials in August, and governance and process improvements have been implemented to avoid similar breaches occurring in future, Sanofi said. The third-party report could give the PMCPA a window into whether Sanofi’s operations support its claims.
The level of scrutiny reflects the PMCPA’s conclusion that Sanofi made misleading claims, across different media outlets, that could undermine public trust in vaccination campaigns. After the Observer quoted Hudson as saying that the U.K. selected Pfizer’s Abrysvo over Sanofi’s Beyfortus on financial grounds, the PMCPA accused the French drugmaker of again undermining the vaccine program in two other articles.
The PMCPA published its report on the two articles alongside the outcome of Pfizer’s complaint about a global Sanofi press release. Sanofi’s press release compared real-world RSV hospitalization rates in Spain and the U.K. to make the case that Beyfortus has a “public health advantage” over Abrysvo. The PMCPA deemed the comparison misleading, driving it to rule that Sanofi brought discredit on the industry.