On June 19th, FDA’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Pfizer Inc. regarding an online direct-to-consumer (DTC) video featuring Estring® (estradiol vaginal ring).
Background
Estring is indicated for the treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause. Last month, the FDA determined that a video interview, featuring spokespersons paid by Pfizer, made false or misleading claims about the risks and efficacy of the product. According to the untitled letter sent in June, the Agency 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, including endometrial cancer, breast cancer, and cardiovascular disorders, as well as numerous contraindications and warnings.”
Although the video did direct viewers to a website for additional information, the video itself did not include any warnings about potential side-effects or risks when using Estring.
Common side-effects of Estring include:
- Headache
- Irregular vaginal bleeding or spotting
- Stomach or abdominal cramps
- Nausea and vomiting
- Vaginal yeast infections
- Fluid retention
Less common but serious side-effects include:
- Heart attack
- Stroke
- Blood clots
- Dementia
- Breast cancer
- Liver problems
False or Misleading Claims about Risk & Efficacy
In the letter sent last month, FDA claims that Pfizer’s video was misleading regarding risk(s) as well as efficacy. Under the Food, Drug, and Cosmetic Act (FD&C Act), by failing to mention any of the serious, life-threatening risks of the product, it is considered misbranded and its distribution is violative.
In addition, a spokesperson in the video claims that “[once] I began using the product it was pretty much an instant relief.” However, according to an OPDP statement issued last month, “FDA is not aware of data to support claims that Estring provides instant relief of moderate-to-severe symptoms of VVA due to menopause.”
OPDP requested a written response from Pfizer by July 3rd, 2018, including a plan for discontinuing the use of the violative marketing materials.
Do you have an FDA-approved product on the market? Want to ensure you are in compliance with all of FDA’s rules and regulations regarding the marketing of your product? We can help. Contact us today to learn more about our services and how we can help you maintain compliance.
