FDA announces proposed changes to nonprescription drug framework

Changes encourage innovative approaches to demonstrating safety and effectiveness

On July 17, FDA released draft guidance, “Innovative Approaches for Nonprescription Drug Products,” which represents the agency’s first step to modernize its regulatory framework for nonprescription drugs, according to a media release from FDA Commissioner Scott Gottlieb. The draft guidance states that product sponsors may use innovative approaches, such as mobile applications or videos, to supplement labeling or provide additional conditions for safe and effective use. The draft guidance does not propose changes to the evidentiary standard needed for a product to be approved as a nonprescription, but rather, expands the methods that can be used to demonstrate a product’s safety and effectiveness.

 

The draft guidance identifies two potential ways a product sponsor may demonstrate safety and effectiveness when the drug facts label (DFL) alone is not sufficient to ensure the product can be used safely and effectively in a nonprescription setting. The two options may involve the use of technology, such as a self-selection test in a mobile application or information displayed on websites, or more common methods of communication, such as information leaflets contained inside the container for the prescription drug product.

 

The first option would be for labeling (e.g., information leaflets, text or images on a video display, information displayed on websites, and statements or questions in a mobile application), in addition to the DFL.

 

The second option is implementation of additional conditions (e.g., consumer completion of self-selection test prior to purchase, consumer views text or images explaining appropriate use of the non-prescription drug product and affirms such viewing) so that consumers can appropriately self-select and use the product.

 

Future steps anticipated by FDA include a proposed rule which is expected to clarify the requirements for prescription drug products that can demonstrate appropriate self-selection by consumers and/or appropriate actual use, to be marketed as a nonprescription drug.

 

APhA will provide comments to FDA regarding the draft guidance. Members interested in providing feedback should contact Jenna Ventresca, APhA director of health policy, at jventresca@aphanet.org by August 15, 2018.