After months of silence about drug company promotional practices, the Food and Drug Administration scolded Pfizer (PFE) over a consumer video that created a “misleading impression” of the Estring vaginal ring because there was no risk information.
The agency objected to a staged interview between a physician and a patient — both of whom were paid and trained Pfizer spokespeople — discussing the ring, which is used to treat moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Not only did the video fail to include risk information, but the patient claimed she did not suffer any side effects while experiencing “instant relief.”
In a June 19 letter to Pfizer, the FDA acknowledged the patient may have correctly described her experience, but argued the video “misleadingly suggests that patients will experience similar results.” The FDA complained this was “especially concerning from a public health perspective” because Estring product labeling mentions several serious, life-threatening risks, including two forms of cancer.
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