In July of this year, the FDA announced new innovative approaches that demonstrate safety and efficacy for nonprescription drug products while expanding consumer access to more products. These innovative approaches (including the involvement of Digital Health Technologies such as apps) are recommended when having just the drug facts labelling (DFL) alone in a nonprescription drug product setting is insufficient to ensure that these over-the-counter (OTC) drugs can be used safely and effectively.

FDA’s Two Innovative Approaches

1. Development of Labelling (beyond the DFL) for Nonprescription Products, such as:

• • Information Leaflets (or other documents) contained in the carton (or containers)
  • Video Display containing texts and images for consumers to review (could be interactive)
  • Information on Websites
  • Statements or Questions in a Mobile Application (App)

2. Implementing Additional Label Conditions that permit the consumer to self-select and self-use the OTC product appropriately, for example:

• Prior to purchase, the consumer is required to answer a set of questions on a mobile app. The results of the test determine if the consumer is an appropriate candidate for the nonprescription drug product.
• Prior to purchase, the consumer is required to answer a set of questions on a mobile app. The results of the test determine if the consumer is an appropriate candidate for the nonprescription drug product.
• Prior to purchase, the consumer is required to view and confirm they have viewed the text and/or images teaching how to appropriately use the nonprescription drug product.

The FDA outlines and expands the details of these two approaches in their new FDA draft guidance document Innovative Approaches for Nonprescription Drug Products. The FDA also encourages applicants to meet with their staff to discuss any questions that arise during the development of nonprescription drug products where added conditions of safe and effective use are proposed.

The guidance clarifies that these innovative approaches apply to drugs that follow the New Drug Application (NDA) regulatory process, and not to drugs that comply with the OTC Drug Review Regulatory Process that complies with a pre-existing OTC Monograph.

Goals of the Nonprescription Drug Product Approaches

The FDA has launched these new innovative approaches to improve access to a greater selection of nonprescription drug products for consumers, empowering them to self-treat common conditions (including chronic conditions) that do not require the supervision of a health care professional. This is part of the FDA’s goal for a new, more modern framework that empowers consumers, heightens efficiencies to products immediately available to the public, and helps lower cost to the health care system.

The FDA also wants to make clear that, while these innovative approaches are intended to expand the range of products that could fall under nonprescription drug category, evidence standards that nonprescription drug products are evaluated against are not changing. Nonprescription products will still have to pass a robust scientific review to ensure that the product can safely be used by patients under this framework. For the new innovative approaches, this could even mean having studies demonstrating that consumers can correctly interpret the novel approach and can safely and properly implement the directions and use the drug without a prescription nor supervision of a healthcare professional.

Do you have questions on what these innovative approaches mean for you and your nonprescription drug products? Wondering if your product will now fall under the wider range of OTC products in the United States? Reach out to dicentra for further guidance on how the FDA’s new nonprescription drug product approaches could present opportunities for your company by filling out the form below or contacting us directly.

1-866-647-3279 | info@dicentra.com

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces.