FDA calls Pfizer Estring marketing misleading
- The Food and Drug Administration's Office of Prescription Drug Promotion sent a warning letter to Pfizer, following its review of a direct-to-consumer video discussing the Estring (estradiol) vaginal ring on the michiganmomliving.com website. The video is of a doctor and her patient, both of whom are Pfizer spokespeople, discussing the benefits of the product.
- The agency called the video misleading because it makes no mention of any risk information about Estring, other than referring the patient to a web site for additional information. The vaginal ring carries a boxed warning regarding serious and life-threatening risks, including endometrial and breast cancer.
- Under the terms of the letter signed by FDA staff on June 19, Pfizer must provide a plan to discontinue using this and any other similar material, or explain why the materials are not in violation, by July 3.
Drug marketing requires a balance between showcasing product benefits and transparency about risks. The Food and Drug Administration's Office of Prescription Drug Promotion plays an important role in maintaining this balance. This is the second such letter sent out this year. The first was in February 2018, warning Collegium for promoting the benefits over the risks of its opioid painkiller Xtampza Extended Release.
One of the key points noted in the letter is where the patient is asked by the physician about side effects and says "I do not experience any side effects... I was able to just feel relief."
As the OPDP points out, the patient's statement only reflects how she feels, not how all patients will feel when using Estring. This could further exacerbate the impression given by the lack of risk information.
"The personal experience of an Estring-treated individual such as 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 information."
Another was the claim from the patient spokesperson that Estring gave "pretty much an instant relief." The agency said this claim could be seen to suggest that all patients will experience similar results.
"While the patient spokesperson’s statement may be an accurate reflection of her own experience as an Estring-treated individual, the personal experience of an Estring-treated individual such as this spokesperson does not constitute support for the suggestion that patients will experience instant relief of their vulvar and vaginal atrophy symptoms after starting Estring therapy."
The data used to gain approval for Estring used endpoints at 12 weeks, and the OPDP's letter has requested to see any data supporting instant relief of moderate-to-severe symptoms.
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