July 2, 2018 – The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter in 2018 to Pfizer Inc., claiming that a direct-to-consumer (DTC) video for the ESTRING® (estradiol vaginal ring), posted on the michiganmomliving.com site, as well as prepared Q&As provided to interview participants (and submitted to the agency under Form FDA 2253), make false or misleading claims “about the risks associated with and the efficacy of Estring.”
In the June 19 letter (https://bit.ly/2tYuEPo), OPDP states that the 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 … [which] creates a misleading impression about the safety and efficacy of Estring.”
Specifically, OPDP alleges that the video for Estring, which is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause, fails to communicate any risk information about the product. “We acknowledge that in the video the Physician Spokesperson refers women to askforthering.com and to their healthcare provider for additional information,” the letter states. “However, this does not mitigate the omission of the risk information from the video.”
The FDA also takes issue with a Patient Spokesperson segment of the video, during which the patient is asked by an interviewer about side effects and she replies that she did not experience any side effects but was “able to just feel relief.” According to OPDP, these statements “misleadingly suggest that patients using Estring will have similar results and will not experience side effects, further exacerbating the misleading impression created by the omission of risk information.”
Additionally, OPDP found fault with the Patient Spokesperson statement that “once we came up with the plan and I began using the product it was pretty much an instant relief.” This efficacy claim, OPDP asserts, “misleadingly suggests that patients will experience similar results, i.e., instant relief of their symptoms, after initiating treatment with Estring.” In the letter, OPDP states that the FDA “is not aware of data to support claims that Estring provides instant relief to moderate to severe symptoms of VVA due to menopause.”
“Letters like this serve as a reminder that while OPDP enforcement actions have been way down in the past year and a half, they have not gone away,” APCO Worldwide Senior Director Wayne Pines told the Coalition for Healthcare Communication. “It remains essential for companies to review promotional materials carefully to assure compliance.”