Pfizer: ESTRING (estradiol vaginal ring)
FDA untitled letter, 19 June 2018. A consumer video interview with paid Pfizer physician and patient spokespersons, posted on a website. FDA objected that it omitted all risk information despite a boxed warning, implied no side effects, and claimed instant symptom relief without supporting data.
The letter
- Date
- 19 June 2018
- Type
- Untitled letter (OPDP)
- Product
- NDA 020472 ESTRING® (estradiol vaginal ring) (NDA 020472)
- FDA matter number
- MA 275
- Promoted piece
- Spokesperson video interview on michiganmomliving.com
- Aimed at
- Consumers (DTC)
- Format
- Online video, Website, Spokesperson or influencer
- Came in under Form FDA 2253
- Yes, the letter says it was submitted on Form FDA 2253
- Close-out
- FDA's source does not say whether this letter was closed out.
What FDA cited
The categories below are this tool's labels, read from the letter. Each quote is FDA's own wording, copied from the letter.
- Omits or minimizes risk
“However, the video fails to communicate any risk information about the product.”
- Overstated or unsupported efficacy
“FDA is not aware of data to support claims that Estring provides instant relief of moderate to severe symptoms of VVA due to menopause.”
- Misleading dosing or convenience
“This claim misleadingly suggests that patients will experience similar results, i.e., instant relief of their symptoms, after initiating treatment with Estring.”
Check your claims before FDA does
Arca reads a promotional piece against the approved labeling and the references it cites, and flags each claim the label does not support. See how Arca supports MLR review. Back to the OPDP letter search.