FDA Policy/General

ParaGard Ad Draws Untitled Letter

A CooperSurgical 30-second TV spot for its ParaGard intrauterine copper contraceptive makes false and misleading representations about the product’s risks, according to a 7/25 Untitled Letter from the CDER Office of Prescription Drug Promotion (OPDP). The letter says OPDP’s Bad Ad Program also received a complaint about the spot. It says the ad misbrands ParaGard and that is concerning from a public health perspective because it creates a misleading impression about the product’s safety.

ParaGard is indicated for intrauterine contraception for up to 10 years. The labeling includes Warnings regarding intrauterine pregnancy, ectopic pregnancy, pelvic infection, immunocompromise, myometrium embedment, perforation, and expulsion. It also lists a number of Precautions and reported adverse events.

OPDP says the TV ad is misleading because it includes claims and representations about ParaGard’s uses and benefits but fails to include important risk information associated with the drug. While there is a statement on screen that the product should not be used if someone has certain cancers, the letter says, the ad fails to include any of the other Contraindications such as acute pelvic inflammatory disease or current behavior suggesting a high risk of pelvic inflammatory disease.

OPDP also says the ad is misleading because it communicates important risk information in the visual portion of the ad only, and TV ads must include information relating to the major side effects and Contraindications in the audio or audio and visual parts of the presentation.

The letter says the company should immediately stop using the violative ad and should respond with a list of all violative promotional materials that will be discontinued.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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