FDA Policy/General

OPDP Cites ‘Misleading’ Paragard Consumer Video

The CDER Office of Prescription Drug Promotion (OPDP) says a CooperSurgical direct-to-consumer video for Paragard (intrauterine copper contraceptive) is false and misleading by presenting efficacy claims for Paragard and failing to communicate any risk information associated with its use. A 2/12 Warning Letter says the video was the subject of a Bad Ad program complaint to OPDP.

The letter says Paragard is indicated for preventing pregnancy in females of reproductive potential for up to 10 years. The labeling contains extensive Warnings, Precautions, and Contraindications, it says. OPDP notes that it previously expressed concerns about Paragard promotional materials in a 7/25/19 Untitled Letter citing a television ad that omitted important risk information.

The letter says the video fails to communicate any risk information and says that referring viewers to a Web site for further information does not mitigate the complete omission of risk information from the video.

“By omitting the risks associated with Paragard, the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” OPDP says. “This misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the drug….”

OPDP also says the company failed to submit a copy of the video at the time of initial dissemination with a copy of FDA-2253 as required by the regulations.

The letter tells CooperSurgical to address the concerns raised in the Warning Letter and list all other Paragard promotional communications that contain representations like those described in the letter and a plan for discontinuing the use of such communications or ceasing distribution of Paragard. The company also is to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective communications about the concerns raised in the letter to the audiences that received the initial promotion.

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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