FDA watchdog admonishes Evofem for marketing brochure for its contraceptive Phexxi
Evofem Biosciences last week received an untitled letter from the FDA, which cited “misleading” benefits in a marketing brochure for its contraceptive gel brand Phexxi.
The regulator said the consumer print pamphlet contains two specific claims that overstate the efficacy of Phexxi in its pages. Both center on statements about preventing pregnancies 99% of the time.
The Office of Prescription Drug Promotion (OPDP), the FDA’s promotions monitoring arm, disputed the 99% figure, which the brochure says is based on efficacy “per acts of sex.” OPDP argues in the untitled letter that the methodology is “not a validated measure to demonstrate the efficacy of contraceptive products.”
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