FDA accuses Evofem of overstating efficacy of contraceptive gel

The FDA has taken Evofem Biosciences to task for allegedly playing fast and loose with the facts, accusing the biotech of overstating the benefits of its contraceptive Phexxi in a digital patient brochure.

Evofem has run some eye-catching ads since winning FDA approval for Phexxi in 2020, getting a "Schitt's Creek" star to say “Welcome to my vagina” in a push to chisel out a space for its prescription vaginal gel in the birth control market.

The push is yet to turn Phexxi into a significant product, with sales hitting just $5 million in the third quarter, and these struggles prompted Evofem to make top-to-bottom cuts back in March.

Now, the FDA has found Evofem overstepped in its efforts to grow sales of Phexxi. The regulator raised the concerns after reviewing a digital patient brochure, which Evofem submitted to the FDA for review and a complainant flagged through the Bad Ad Program. 

In its brochure, Evofem stated that “99% of pregnancies were prevented per act of sex” and that “Phexxi prevented pregnancy 99% of the time.” Those claims sent alarm bells ringing at the FDA. As the agency explained in its letter to Evofem, the likelihood of an “act of sex” leading to pregnancy varies depending on the timing of intercourse in relation to ovulation.

As such, the FDA said “calculating the pregnancy prevention rate based on ‘per act of sex’ misleadingly overestimates the effect of Phexxi on pregnancy prevention.” The shortcomings of calculating efficacy based on “act of sex” is unlikely to be news to Evofem. The label for Phexxi uses the efficacy calculation favored by the FDA, which gives the gel an 86% cumulative pregnancy prevention rate. 

Evofem acknowledged “these data are not found in the Product Information and have not undergone the same rigorous evaluation as other data from the study” in the product brochure. However, that nod to the limitations of the data failed to “mitigate the misleading overstatement of efficacy created by these claims,” according to the U.S. regulator.

The FDA gave Evofem 15 working days to respond to its untitled letter.