The US Food & Drug Administration (FDA) serves as the gatekeeper between pharmaceutical companies and the public they serve, including governing how medications are promoted and advertised. Pharmaceutical companies want to go above and beyond the product label to provide useful (and, for the company, strategic) information to customers. But at the same time, FDA regulators must ensure that such information is truthful and not misleading.

In the past, the practice of off-label promotions has strained this relationship, leading to conflict and even litigation between the agency and pharmaceutical manufacturers.

But a number of factors, including several recent enforcement actions as well as new state laws, indicate the FDA may be clarifying and improving how it handles off-label promotions. That is good news for the pharma industry.

Drs. Francis Nguyen and Frances Sousonis examine the latest developments in a new article for Regulatory Focus (subscription required)*. Nguyen and Sousonis point to two recent off-label promotions cases—2014’s US v. Pacira Pharmaceuticals and 2015’s Amarin Pharmaceuticals, Inc. vs. FDA —as milestone cases. In both cases, the pharmaceutical companies successfully argued that off-label promotions were constitutionally protected free speech, as long as the language used met the “truthful and not misleading” standard.

In the Pacira case, the FDA ultimately resolved the issue by requiring the company to incorporate additional, more precise language into its label. In Amarin, Nguyen and Sousonis find that the company’s current, FDA-accepted off-label promotions “were supported by studies with pre-specified endpoints in addition to a plethora of disclaimers.”

Arizona and Tennessee also have passed state laws permitting the truthful promotion of off-label pharmaceutical use, while Missouri lawmakers are considering similar legislation. Such state-level actions may provide additional clarity on what pharmaceutical companies should and shouldn’t include in off-label promotions.

In their Regulatory Focus article, Nguyen and Sousonis say that these factors combined are helping move the regulatory climate in favor of off-label promotions.

“Amarin’s off-label promotion of Vascepa, and Pacira’s Exparel label update are examples demonstrating FDA’s forward thinking and consideration on how off-label communication may be approached in the future,” Nguyen and Sousonis write. “Perhaps the pharmaceutical industry and stakeholders are now better equipped with additional resources and examples by which they can navigate the ‘murky waters’ regarding off-label communications.”

For regulatory consultation of your FDA-regulated product, contact Dr. Heather Hatcher, Regulatory Scientist in Womble Bond Dickinson’s Winton-Salem office.

Heather Hatcher, Ph.D. , is a regulatory scientist on Womble Bond Dickinson’s Life Sciences and Pharmaceuticals Sector Team. Drawing on her background as a research scientist, Hatcher guides clients through FDA regulatory strategies and product development issues for drugs, biologics and medical devices. Her experience includes the preparation of pre-submissions, initial Investigational New Drug (IND) and Investigation Device Exemptions (IDE) applications, annual progress reports, and FDA meeting requests.

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[*] Nguyen F and Sousonis F. “Clarifying FDA’s Off-Label Promotion Efforts.”

Regulatory Focus. September 2018. Regulatory Affairs Professionals Society.