We thought our readers might be interested in a recent Untitled Letter that FDA sent to Zydus Discovery DMCC, the US agent/subsidiary of Indian pharmaceutical company Zydus Cadila, alleging that the company’s promotional claims for the product on YouTube, prior to obtaining FDA approval for the drug in the U.S., caused the product to be misbranded under the U.S. Federal Food, Drug, and Cosmetic Act.
Zydus launched the drug Lipaglyn™ (Saroglitazar) in India, which is approved by Indian regulators to treat Type 2 diabetes patients with hypertriglyceridemia or diabetic dyslipidemia, not controlled by statins alone. Saroglitazar is not, however, approved for any indication in the US. Zydus is currently studying the drug in Phase 2 trials (under an FDA-approved IND) for possible US indications in dyslipidemia and NASH.
The Dec. 21, 2016 Untitled Letter cites Zydus Discovery DMCC for preapproval promotion of Saroglitazar. (FN: FDA has requested a response to the Untitled Letter by Jan. 6, 2017. Cadila Healthcare Ltd., who markets the drug in India, noted on Wednesday that it has already taken responsive corrective action.) Specifically, FDA took the position that a YouTube® video posted by a Zydus representative, in which safety, efficacy, and superiority claims are made about Saroglitazar, renders the investigational drug misbranded under 21 USC 352(f). Among other things, FDA alleged that the YouTube content caused the drug to be misbranded because the content includes unsubstantiated compound-specific safety and efficacy claims (e.g., “novel, superior, dual acting” and “dual lipid and glycemic control”), associates these claims with the Lipaglyn proprietary name, and is cross-linked to a Lipaglyn promotional website. The cross-linked Lipaglyn.com promotional website was not access-restricted or user-limited in any way (e.g., with a “speed bump” or other viewer acknowledgement message). (FN: We note that in response to the Untitled Letter, a disclaimer that the drug is only approved in India now appears on the site). And, according to FDA, some of the claims in the YouTube video were also present in a branded Lipaglyn booth banner used by the company at the American Diabetes Association Scientific Sessions meeting this past June.
The Saroglitazar Untitled Letter is an important reminder of why FDA-regulated companies and their communications agencies need to continue to be sensitive to pre-approval promotion risks not only in traditional promotional channels, but also when developing web-based and social media content. Companies with global brands must take into account local marketing restrictions when developing global web and social media content. This is particularly important for companies conducting studies in the US on investigational compounds that have been approved in other jurisdictions. Pre-approval “pipeline” presentations, trial recruitment initiatives, investor communications, and disease awareness activities should all be subject to careful review to ensure that they do not run afoul of the regulatory requirements that govern the target audience. However, global marketing teams should not despair: often, creative web and other content design (e.g., thoughtful “redirect” messages, well-placed disclaimers, use of country-specific URLs, etc.) can be a way to artfully manage US regulatory expectations while also meeting global communication needs in a competitive business environment.