Following the FDA’s September announcement of a crackdown on direct-to-consumer drug marketing practices and the subsequent flurry of untitled and warning letters criticizing dozens of Big Pharma ads, it’s largely been all quiet on the marketing missive front.
That is, until this week, when the FDA’s Office of Prescription Drug Promotion (OPDP) posted a new untitled letter dated Sept. 23 and addressed to AstraZeneca.
The letter takes aim at a TV commercial for the drugmaker’s Farxiga that focuses on the med’s uses in chronic kidney disease (CKD) and heart failure (HF). For CKD patients, Farxiga is approved to reduce the risk of worsening disease, end-stage disease, death due to cardiovascular disease and hospitalization for HF. For HF patients, it’s used to lower the risk of cardiovascular death, hospitalization and urgent heart failure visits.
As the OPDP notes, the 45-second ad includes onscreen text claiming Farxiga “can help you keep living life by reducing the risk of cardiovascular death,” without mentioning the rest of its approved indications.
According to the agency, the commercial is therefore “misleading” because it suggests the drug is approved for only that purpose in people with CKD or HF and leaves out the fact that Farxiga was greenlit based on composite endpoints assessing all of the aforementioned outcomes.
“By failing to adequately communicate all of the components that contribute to the indications for these respective populations, the TV ad creates a misleading impression about the FDA-approved indications for Farxiga in adults with CKD and HF,” the letter concludes.
The FDA gave AstraZeneca 15 business days to respond to the letter, along with a request that the company “take immediate action to address any violations.”
In a statement sent to Fierce Pharma Marketing, an AstraZeneca spokesperson said, “AstraZeneca complies with all laws and regulations that govern prescription drug direct-to-consumer advertising in the United States. We remain committed to ensuring that the public, including patients and healthcare providers, have access to accurate and balanced information about treatment options.”
The British Big Pharma was among the many drugmakers to receive multiple untitled letters in the September deluge. It was named in six of the letters, while another went to its rare disease subsidiary Alexion.
Three of the missives concerned various TV ads for asthma treatment Fasenra, and two more targeted commercials for cancer drugs Calquence and Truqap.
The sixth letter, meanwhile, came from the FDA’s Center for Biologics Evaluation and Research—rather than the Center for Drug Evaluation and Research, where the OPDP is housed—because it concerned a TV spot highlighting at-home use of AstraZeneca’s self-administered FluMist influenza vaccine.
Each of the letters detailed the FDA’s belief that various elements of the company's commercials created “false or misleading” impressions of their respective products.
Editor's note: This story was updated to include a statement from AstraZeneca.