On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a proposed rule amending the agency's regulations concerning "intended uses." While the proposed rule does not signal a fundamental change in FDA's position that all relevant sources of evidence may be considered, it attempts to make clear what sort of evidence is not on its own sufficient to demonstrate a product's intended use.
FDA clarifies its position on what types of evidence are acceptable and sufficient (and which are not) by making a number of noteworthy changes and additions to the existing rule. For instance, the amendment proposed by FDA would add examples of types of evidence that the agency would consider relevant in determining the intended use of a given product, including:
- Express claims and representation, such as labeling claims, advertisements, or oral or written statements by individuals who are responsible for the labeling (or their representatives);
- Implied claims, such as claims or statements made by a company that implicitly represent a product for a particular use, such as names like "Chronix," "Shroomz" or "e-Cialis" and representations that the product contains a particular ingredient in order to imply a physiological effect (for instance, including "aspirin" or "sildenafil" in an ingredient list);
- Product characteristics and design, such as the product's technical features, which might suggest that the product is intended for a use different from its purported use; and
- Circumstances of the sale or distribution, such as to whom, for whom and where the products are offered.
The proposed rule identifies types of evidence (along with examples of such evidence) that would not be determinative of intended use, such as a firm's knowledge that its approved product is being prescribed or used by healthcare providers for the unapproved use. The rule offers the following scenario as an example. A pharmaceutical firm tracks sales and distribution data and recognizes that one of its products, which is approved for use only in adults, is being ordered and distributed to many medical practices that only treat children. In this situation, where the firm does not provide any direction to its sales or marketing staff to disseminate samples or information to these pediatric practices, such knowledge by the firm, on its own, is insufficient to demonstrate the product's intended use.
The proposed rule also includes examples of other types of evidence that likely would not be sufficient alone to establish intended use. One scenario constituting this type of insufficient evidence centers on a pharmaceutical company's CEO displaying a presentation slide during an internal meeting with the sales projections for an approved product that includes potential sales for an unapproved use that is widely recognized as the standard of care. Another considers a firm making corporate filings or submissions to the SEC that include the required disclosures or development activities, or potential or actual sales, for a product's unapproved use.
Additional details and examples are contained in the proposed rule. Industry participants and members of the public have until October 23, 2020, to submit comments on the proposed rule.
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