FDA Final Rule on Intended Use

Medical products regulated by the FDA are evaluated based on their intended use. Companies are not allowed to promote uses of regulated products for off-label uses, although medical providers are permitted to prescribe off-label uses. The limitations on companies has been of issue for years. Clarifying what constitutes off-label promotion and what is “intended use” is crucial for companies complying with their legal requirements.

Over the weekend, FDA published a final rule regarding intended use finalizing the proposed rule. The proposed rule, published in late 2020, amends the regulation of intended use to include objective and subjective intent. Objective intent is determined by evidence including labeling claims, advertising and sponsor statements. Subjective intent is based on the firm’s claims.

“Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm's knowledge that such drug was being prescribed or used by health care providers for such use.”

Intended use is generally the use of the medical product, and is often included on the product label, but is not limited to labeling. Advertising and promotional materials can also be used to determine intended use. The final rule includes other sources as information to help determine the product’s intended use. Other sources include implied claims, product characteristics and design, and circumstances of the sale or distribution.

One key piece of information is that FDA does not consider a company’s knowledge of off-label use as intended use for the purposes of a prohibited act.

Companies that promote off-label use of their regulated products may be subject to FDA enforcement actions, starting with warning letters (see here for one relatively recent example) and eventually prosecution and fines for violating the Federal Food Drug and Cosmetic Act and the False Claims Act.