CooperSurgical, Inc. – FDA Warning Letter, Feb 23, 2021

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to CooperSurgical, Inc. regarding a direct-to-consumer video for Paragard (intrauterine copper contraceptive) titled “Paragard: Family Planning During The Pandemic.” The video, submitted via the FDA Bad Ad Program, was found to be false or misleading because it presented efficacy claims without communicating any risk information, thereby misbranding Paragard under 21 U.S.C. 352(a), (n); 321(n); 331(a) and 21 CFR 202.1(e)(5). This omission is a significant public health concern due to the drug's serious risks. Additionally, the promotional communication was not submitted to the FDA at the time of initial dissemination, violating 21 CFR 314.81(b)(3)(i). This is particularly concerning as OPDP had previously sent an Untitled Letter in 2019 for similar issues with Paragard promotional materials. CooperSurgical is required to cease all violations, submit a written response within 15 days detailing corrective actions, list other similar promotional communications, and provide a comprehensive plan for disseminating truthful, non-misleading corrective communications to the affected audience.