FDA Policy/General

Brochure Overstates Phexxi Benefits: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says an Evofem Biosciences direct-to-consumer brochure for its Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel overstates the expected benefits associated with using the product. A 10/31 Untitled Letter says the brochure makes false and misleading claims and representations about Phexxi’s benefits. It says the FDA Bad Ad Program received a complaint about other promotional communications with similar claims and presentations.

OPDP says Phexxi is indicated to prevent pregnancy in females of reproductive age for use as an on-demand method of contraception. The labeling includes Warnings and Precautions about cystitis and pyelonephritis.

The letter says the brochure’s claim that Phexxi prevented pregnancy 99% of the time is based on efficacy “per act of sex,” which OPDP says is not a validated measure to demonstrate the efficacy of contraceptive products, since it incorrectly assumes that the likelihood of becoming pregnant is the same with each act of sex throughout the menstrual cycle.

“The suggestion that Phexxi prevented pregnancy 99% of the time, in contrast to the pregnancy prevention rates (72.5%-86%) noted in the prescribing information overstates the efficacy of the product,” OPDP says.

Evofem was told to respond with a listing of all promotional communications for Phexxi that contain representations like those described in the letter and a plan for discontinuing the use of such communications or stopping the distribution of Phexxi.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome