On February 12, 2021, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to CooperSurgical, Inc., over a direct-to-consumer video “sponsored by PARAGARD.”
According to OPDP, the video was submitted as a complaint to the FDA Bad Ad Program and is considered to be false or misleading as it presents efficacy claims for Paragard but does not communicate any risk information associated with its use. Therefore, it misbrands Paragard within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its distribution is prohibited. OPDP also noted that the promotional video, “Paragard: Family Planning During the Pandemic,” was not submitted at the time of initial dissemination or publication as required by the Code of Federal Regulations.
False and Misleading Risk Information
The video begins with a voiceover statement that indicates “This segment is sponsored by Paragard” and includes a simultaneous visual presentation of the logo and proprietary and established names for Paragard along with the Paragard URL. The video then transitions into a physician interview, complete with claims and representations about the use of and/or benefits of Paragard. While the interview is going on, superimposed text is on the screen, “FAMILY PLANNING DURING THE PANDEMIC PARAGARD’S NON-HORMONAL OPTION.”
While the video makes claism about the use and/or benefits of Paragard, it does not communicate any risk information about the product. While OPDP notes that viewers are referred to www.paragard.com for further information about the drug, that direction “does not mitigate the complete omission of risk information from the video.” OPDP states that by omitting the risks associated with Paragard, the video does not provide any material information about the consequences that may result from the use of Paragard, thereby creating a misleading impression about its safety.
OPDP notes that the misleading presentation is “particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the drug, such as those contained in the WARNINGS AND PRECAUTIONS section of its own product labeling.
Failure to Submit
In addition to the misleading statements (and lack of warning), CooperSurgical did not submit a copy of the video to OPDP at that time of its initial dissemination as required by 21 CFR 314.81(b)(3)(i). Companies are required to submit the promotion, with a Form FDA-2253 Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use and a copy of the product’s current professional labeling.
Previous Concerns
OPDP has previously expressed concerns regarding Paragard promotional materials. In July 2019, OPDP sent CooperSurgical an Untitled Letter for a Paragard Direct-to-Consumer television advertisement that similarly omitted important risk information.
Request for Action
OPDP asked CooperSurgical to provide a written response to their concerns, including a list of all other promotional communications (with the 2253 submission date) for Paragard that contain similar representations, and a plan for discontinuing the use of those communications or ceasing distribution of Paragard.