After posting an allegedly misleading marketing video promoting its Estring (estradiol) vaginal ring on a consumer website, American pharmaceutical giant Pfizer has received a warning letter from the FDA. The video – which featured two Pfizer employees portraying a physician and her patient – was originally posted in May of 2017 on michiganmomliving.com but has since been taken down from the site.
According to the FDA’s Office of Prescription Drug Promotion, the promotional video only discussed the benefits of the Estring device in managing symptoms of menopause. Pharmaceutical marketers are required to adhere to strict rules for their promotions of products which includes disclosing risk information – something that the Estring video didn’t do.
“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,” said the warning letter. “The video thus creates a misleading impression about the safety and efficacy of Estring.”
Pfizer was required to respond to the claims made in the warning letter by July 3. They were given two options: inform the FDA of how they plan to discontinue using the misleading video to promote Estring, or provide evidence to refute claims that the interview violated the agency’s promotional rules. By removing the video from the website and from YouTube, it’s likely that Pfizer has chosen the latter option in dealing with this issue.
“We acknowledge that in the video the Physician Spokesperson refers women to askforthering.com and to their healthcare provider for additional information,” said the FDA letter. “However, this does not mitigate the omission of the risk information from the video.”
The FDA argues that several statements made by the Physician Spokesperson and the Patient Spokesperson in the video interview could mislead women about the potential benefits and side effects of using Estring. For example, when asked about side effects, the Patient Spokesperson for Pfizer answered that she didn’t experience any and only felt relief after using the Estring device. According to the FDA, this suggests that other patients using Estring won’t experience any side effects either, despite the fact that the product contains a boxed warning outlining several serious risks of the device that have been identified in patients.
What’s more, the patient interviewed claims she experienced “instant relief” upon using the Estring device, further misleading women with vulvar and vaginal atrophy (VVA) due to menopause that their symptoms would also instantly disappear upon inserting the device. The FDA also points out that Pfizer has never submitted any data substantiating the claim the device could provide instant relief of symptoms; instead, the efficacy of the device has only been studied after 12 weeks of use.
“If you have data to support the claim that patients using Estring experience instant relief of moderate to severe symptoms of VVA due to menopause, please submit such data to FDA for review,” said the FDA’s letter to Pfizer.
Hormone replacement therapy (HRT) to treat the symptoms of menopause has generally fallen out of favour in recent years over concerns that estradiol could contribute to the development of certain types of cancer. However, according to the North American Menopause Society, healthy women under the age of 60 could still benefit from HRT without facing an unreasonable risk of experiencing side effects as a result of treatment.