FDA considering all options for positively impacting both access and the cost of health care. FDA announcing a new effort to establish innovative approaches to increase access to a broader selection of nonprescription drug products for consumers, empowering them to self-treat common conditions and potentially some chronic conditions.
Clearly, not all prescription drugs can or should be available directly to consumers. Many require a professional diagnosis and oversight to ensure the benefits of use outweigh the risks. But other, select types of drugs, are appropriate for nonprescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them. These are the products that we will carefully consider for this innovative pathway. These approaches include applying innovative tools, like digital health technologies, that would support consumers in appropriately and safely self-selecting and using certain drugs.
Nonprescription drug products are used by consumers without the supervision of a health care professional and require a very high safety margin that takes into consideration the potential consequences of inappropriate use, the ability of the consumer to determine that they have the condition for which the drug is to be used, and the expected effectiveness of the product when used under nonprescription conditions.
Consumers may recognize the “Drug Facts Labeling” (DFL) on nonprescription drug packaging as the primary source for information about a product’s intended use, directions for use and important safety information, all designed in understandable language that is tested for consumer comprehension. As we look at expanding the types of products available without a prescription, the safety of patients remains a top priority.
Currently, nonprescription drugs can be marketed under either of two regulatory pathways: the Over-the-Counter (OTC) Drug Review (OTC Monograph Process) or the New Drug Application (NDA) process, and there are different requirements under each system.
This draft guidance outlines two innovative approaches for demonstrating safety and effectiveness that may be useful to consider in cases where the DFL alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting. The first is the development of labeling in addition to the DFL. The second approach is the implementation of additional conditions so that consumers appropriately self-select and use the product. Either of these approaches could involve the use of technology, such as mobile apps or other tools. The appropriateness and specific details of either of these approaches will depend on the circumstances that apply to a particular drug product.
The innovative approaches described in this draft guidance could lead to the approval of a wider range of nonprescription drug products, including drug products that may treat chronic conditions, in ways that maintain the FDA’s gold standard for safety and effectiveness. This will require coordination and collaboration with industry and other stakeholders to strike the right balance of access while protecting public health and we’re committed to a public process that allows for input from a broad range of voices on the impact of this proposed policy.
