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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