The US Food and Drug Administration (FDA) has issued draft guidance, Innovative Approaches for Nonprescription Drug Products, as part of the agency’s effort to increase access to nonprescription drugs to increase drug competition.

“While the FDA doesn’t have a direct role in the cost of medicines, we’re very mindful of the time and financial cost to patients and the healthcare system to fill a prescription medicine—particularly one taken repeatedly for chronic conditions,” Gottlieb said in a July 17, 2018 agency statement. “Our hope is that the steps we’re taking to advance this new, more modern framework will contribute to lower costs for our healthcare system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription.”

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. The draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the NDA process and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription.

“We envision this process will work as follows – a sponsor, for example one that has a prescription cholesterol-lowering drug or a prescription naloxone product, could develop one of these innovative approaches to increase the likelihood of correct self-selection and accurate use of their product in the nonprescription setting,” said Gottlieb in his statement. “After performing appropriate studies demonstrating that the novel approach works as intended, in other words, that consumers can safely use the drug without a prescription and associated supervision of a healthcare professional, the sponsor could submit an application for FDA consideration for nonprescription status for the product.”

The draft guidance outlines two new approaches for demonstrating safety and effectiveness that may be useful to consider in cases where the drug-fact labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting. The DFL on nonprescription drug packaging is 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.

The first approach is the development of labeling in addition to the DFL. The second approach is the implementation of additional conditions so that consumers could 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.

“But it’s important we’re clear that we are not proposing a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription,” FDA Commissioner Scott Gottlieb said in the July statement. “As we move into making this a reality, the FDA will ensure that products considered under this framework receive a robust scientific review to ensure they can be used safely by patients.”

Gottlieb said that the new approaches described in the 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 standards 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, said Gottlieb in his statement.

Gottlieb says the FDA intends to continue this effort with proposed rulemaking in the near future and will provide additional information as it moves forward. The proposed rule will clarify the requirements for a drug product that could be marketed as a nonprescription drug product with a requirement that ensures appropriate self-selection by consumers, appropriate actual use, or both, in order to obtain the drug without a prescription.

Source: FDA