Regulatory Focus™ > News Articles > 2021 > 2 > OPDP warns Paragard maker over promotional video

Regulatory NewsRegulatory News
Posted 23 February 2021 | By Michael Mezher 

OPDP warns Paragard maker over promotional video

3009 A sponsored video that aired on NBC’s Boston affiliate in October has landed CooperSurgical a warning letter from the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) for failing to include risk information about the company’s Paragard intrauterine device (IUD).
The warning letter is the second sent by OPDP in 2021 and is the second enforcement letter sent to CooperSurgical concerning Paragard. In 2019, OPDP sent the company an untitled letter over a television advertisement that similarly omitted important risk information about the product. (RELATED: OPDP issues untitled letter over birth control device TV ad, Regulatory Focus 31 July 2019; OPDP warns AcelRx over Dsuvia promotional materials, Regulatory Focus 16 February 2021).
“[CooperSurgical] appears to be promoting Paragard without presenting the serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP,” the letter states.
FDA says the video, “Paragard: Family Planning During The Pandemic,” presented efficacy claims for Paragard, but failed to mention any risk information associated with the product. The video has since been removed from NBC Boston’s website.
Paragard is approved for intrauterine contraception for up to 10 years and carries several contraindications, warnings and precautions.
Some of the contraindications for Paragard include that it should not be used during pregnancy or in patients with certain uterine abnormalities, acute pelvic inflammatory disease, recent postpartum endometritis, Wilson’s disease or an allergy to copper or any of the trace elements present in the copper component of the product. Warnings about Paragard include the risk for intrauterine pregnancy, ectopic pregnancy, pelvic infection, immunocompromise, sepsis, embedment, perforation and expulsion.
According to the warning letter, the video begins with a voiceover stating the segment is sponsored by Paragard and presenting the product’s logo and website URL. “The remainder of the video features a physician being interviewed and includes claims and representations about the use and/or benefits of Paragard … However, the video fails to communicate any risk information about the product,” FDA writes. While the video refers viewers to for more information, FDA says this “does not mitigate the complete omission of risk information in the video,” and creates a misleading impression about Paragard’s safety.
“This misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the drug,” FDA writes.
The agency also says that CooperSurgical failed to submit the video using Form FDA-2253 as required at the time of its initial dissemination.
In response to the warning letter, FDA requests CooperSurgical cease any violations and submit a written response within 15 days addressing the concerns raised in the letter and listing other promotional communications for Paragard that contain similar representations. FDA says the response should also include a plan for discontinuing those communications or ceasing distribution of Paragard.
In addition, FDA says the company must provide a comprehensive plan to disseminate corrective communications to the same audience(s) that received the promotional communication cited in the letter.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found