Estring Video Has False, Misleading Claims: OPDP
CDER’s Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer video of an interview featuring paid and trained Pfizer spokespersons about its Estring (estradiol vaginal ring) makes false or misleading claims and/or representations about the product’s risks and efficacy. A 6/19 notice of violation says 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.”
Estring is indicated for treating moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. It is contraindicated in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis; pulmonary embolism or a history of these conditions; active arterial thromboembolic disease, or a history of these conditions; known anaphylactic reaction or angioedema or hypersensitivity to Estring; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders; and known or suspected pregnancy.
OPDP says the video features a physician and one of her patients, both of whom are acknowledged as Pfizer spokespeople. It contains claims and/or representations about Estring’s benefits, the letter says, but fails to communicate any risk information. OPDP acknowledges that in the video the physician refers women to a Web site for additional information and suggests they talk to their healthcare provider. “However,” it says, “this does not mitigate the omission of the risk information from the video. By omitting the risks associated with Estring, the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety.”
In addition, OPDP writes, the patient spokesperson’s comment that she did not experience any side effects with Estring may be an accurate reflection of her own experience but misleadingly suggests that other patients will have similar results and will not experience side effects, further exacerbating the misleading impression created by the omission of risk information.
The letter also says that the patient spokesperson’s claim of “pretty much an instant relief” misleadingly suggests that patients will experience similar results after starting Estring treatment. “Estrogens, including Estring, typically require an interval of time to improve the signs and symptoms of vulvar and vaginal atrophy, and FDA is not aware of data to support claims that Estring provides instant relief of moderate to severe symptoms … due to menopause,” OPDP says.
Pfizer was asked to immediately stop violating the Federal Food, Drug, and Cosmetic Act in ways described in the letter and to respond with a list of violative promotional materials and a plan for discontinuing their use.
This is only the second enforcement letter OPDP has issued this year.