OPDP Issues Untitled Letter Over Birth Control Device TV Ad

Regulatory NewsRegulatory News
| 31 July 2019 | By Michael Mezher 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to CooperSurgical last week over misleading claims made in a television advertisement for its hormone-free prescription intrauterine birth control device ParaGard.
OPDP says the letter, its fourth in 2019, was prompted by its review of the Form 2253 submitted by CooperSurgical for the ad and notes that the agency received a complaint about the ad via its Bad Ad Program.
Paragard is approved for intrauterine contraception for up to 10 years and carries several contraindications, warnings and precautions.
Some of the contraindications include that the device should not be used during pregnancy, or in women with certain uterine abnormalities, acute pelvic inflammatory disease, recent postpartum endometritis, Wilson’s disease or an allergy to any component of the device.
Warnings for Paragard include the risk for intrauterine pregnancy, ectopic pregnancy, pelvic infection, immunocompromise, myometrium embedment, perforation and expulsion.
According to OPDP, the TV ad cited in the untitled letter is misleading because it fails to mention important risk information about the product.
Despite onscreen text in the ad stating “Don’t use Paragard if you have certain cancers,” and a recommendation that patients using the device call their healthcare provider if they experience pain or pelvic infection, OPDP says the ad fails to mention any other contraindications and “fails to adequately communicate the material fact that ParaGard is associated with an increased risk of pelvic inflammatory disease (PID) and that PID can have serious consequences.”
OPDP also says the ad fails to mention the risk of expulsion with the product, and thus “misleadingly suggests that ParaGard is safer than has been demonstrated.”
Another issue, OPDP says, is that the risk information presented in the ad is “undermined” by fast-paced and attention-grabbing visuals that are unrelated to the risk information in the accompanying audio or superimposed text.
OPDP also takes issue with the fact that the ad presents unrelated benefit and risk information simultaneously. In one instance, OPDP says the ad displayed risk information about vaginal bleeding in superimposed text while audio and visual claims were presented about the product’s benefits.
Additionally, OPDP says the ad’s emphasis on ParaGard being hormone-free, while true, creates a “misleading impression of the safety profile of the drug,” noting that ParaGard is associated with some of the same risks as other long-acting reversible contraceptives.
In response to the letter, OPDP asks that CooperSurgical cease distributing the ad and submit a written response to the agency by 8 August stating whether the company will comply with the agency’s request and providing a list of any other violative promotional materials.
FDA, Promotional Materials


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