Drug marketing regulator sounds the alarm over Novartis' Entresto podcast claims

Novartis has been consistently pushing the boundaries in digital pharma for years. However, the company has now encountered the intricate challenges associated with navigating regulatory guidelines. This has become evident as the Big Pharma has been hit with the U.K.'s most serious drug marketing breach.

This latest case surrounds a podcast show called “Heart to Heart,” which was developed specifically for heart failure specialist nurses (HFSN). In one of the episodes, Novartis presented a series of efficacy claims and, even more significantly, safety claims. These assertions caught the attention of the PMCPA, the organization responsible for overseeing drug marketing regulations in the U.K.

The claims that drew the PMCPA's concern involved the assertion that Entresto could potentially lead to an increase in energy levels. Notably, this claim was tied to the act of dressing and the energy expended during this activity. The PMCPA deemed the claim "misleading as it was incapable of substantiation."


The most serious claim for the PMCPA was Novartis’ reference on the podcast to a “slight but acceptable drop in renal function” with Entresto, a safety claim. The self-regulatory body said the claim came “without any qualification” and “downplayed the importance of renal function.”

Because this claim was deemed misleading by the PMCPA and evolved around matters of safety, the PMCPA determined that Novartis "reduced confidence in, and brought discredit upon, the industry." This verdict amounted to a breach of the gravest nature, falling under Clause 2 of the ABPI Code, the most significant breach possible.

The case concerning the podcast was initiated by an anonymous complainant who identified themselves as a cardiac specialist health professional.

In a statement to Fierce Pharma Marketing Novartis U.K. said: “Novartis UK have received notice from the self-regulating body, the PMCPA, regarding a number of findings. We strongly regret the breaches and  have reviewed our internal processes. We remain committed to being a responsible partner for patients and the healthcare system.”

This breach for Novartis is the second in as many months for Entresto as it comes after the PMCPA also wrapped the Big Pharma for not fully showing the drug’s safety risks on the therapy’s website.