FDA Calls Out Pfizer DTC Video as Misleading

Regulatory NewsRegulatory News | 02 July 2018 |  By 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last month sent an untitled letter to Pfizer, calling out an online direct-to-consumer (DTC) video of an interview featuring paid and trained Pfizer spokespersons as offering false or misleading claims on the risks associated with Estring (estradiol vaginal ring), a treatment for moderate-to-severe symptoms of vulvar and vaginal atrophy due to menopause.

“This video is especially concerning from a public health perspective because it fails to include any risk information about Estring, which is a drug that bears a boxed warning due to several serious, life-threatening risks, including endometrial cancer, breast cancer, and cardiovascular disorders, as well as numerous contraindications and warnings,” the letter says. “The video thus creates a misleading impression about the safety and efficacy of Estring.”

FDA acknowledged that the video does direct viewers to a website or physician for additional information, but “this does not mitigate the omission of the risk information from the video.”

The agency also took issue with one spokesperson’s personal experience with using Estring, noting “this spokesperson does not constitute support for the suggestion that other patients will not experience adverse events after starting Estring therapy and does not obviate the requirement to present risk.”

A Pfizer spokesman told Focus: “Pfizer recognizes the importance of appropriately communicating about medical conditions and the risks and benefits of our medications. We take this matter very seriously and remain committed to complying with all applicable laws and regulations.”

This is OPDP’s second untitled letter of 2018, which compares with a record low number of letters sent in 2017.

Untitled Letter to Pfizer


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