In June 2018, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent its second Untitled Letter for 2018 to Pfizer, calling out an online direct-to-consumer (DTC) video of an interview featuring paid and trained Pfizer spokespeople as offering false or misleading claims on the risks associated with Estring, 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.”
While the FDA acknowledged that the video does direct viewers to a website or physician for additional information, “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.” The Patient Spokesperson in the ad is directly asked by the interviewer about side effects, to which she replies, “I do not experience any side effects. I’m, for me, I, I was able to just feel relief.”
The FDA also took issue with the fact that at the end of the interview, the Physician Spokesperson was asked by the interviewer whether there was anything missed in the interview and instead of discussing any possible risks or side effects, the Physician Spokesperson “declined to take this opportunity to disclose any of the risks of Estring.”
The video was posted on a Michigan Mom Living blog and according to Pfizer has since been taken down.
A Pfizer spokesman told reporters, “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.”
The letter to Pfizer is only the second one the OPDP has issued so far this year. In February, Collegium Pharmaceuticals received a letter over an exhibit booth for its painkiller Xtampza ER (oxycodone) extended-release capsules. In 2017, ODPD issued only three warning and untitled letters for advertising violations. In 2016, the OPDP issued 11 letters. These numbers stand in stark contrast to 2010, when 52 were issued.