The FDA encourages NDA applicants to meet with its staff to discuss any questions that arise during development of nonprescription drug products for which additional labeling or conditions may be effective.

In an effort to provide approval of a wider range of nonprescription drug products, the U.S. Food and Drug Administration (FDA) has issued a draft guidance, entitled “Innovative Approaches for Nonprescription Drug Products.” 

The FDA approves new drug applications (NDAs) for nonprescription drug products based on information that ensures the drug product is safe and effective for use without the supervision of a healthcare practitioner. One way to prove that a drug is safe and effective for nonprescription use is through self-selection studies that test whether consumers can apply information from the product’s drug facts labeling (DFL) to correctly decide whether the drug can be used for their personal medical situation. Another type of study is one that shows how consumers will actually use the drug product.

However, in instances where the DFL alone would not be sufficient to provide for adequate self-selection, the FDA suggests that the NDA applicant may consider proposing innovative approaches to labeling. Some examples of the type of additional labeling information that the FDA may consider include:

• Information leaflets or other documents contained inside the carton or container for the nonprescription drug product
• Text or images on a video display, including interactive displays for consumers to review
• Information displayed on websites
• Statements or questions in a mobile application

In addition to labeling innovations, the FDA may consider innovative approaches that require the consumer to meet additional conditions prior to selection, including:

• Prior to purchase, the consumer is required to respond to a set of questions on a self-selection test in a mobile application, and the outcome of the self-selection test affirmatively indicates that the consumer is an appropriate candidate to use the nonprescription drug product.
• Prior to purchase, the consumer is required to view and affirm that they viewed text or images in a video that describes how to appropriately use the nonprescription drug product.

The FDA encourages NDA applicants to meet with its staff to discuss any questions that arise during development of nonprescription drug products for which additional labeling or conditions may be effective. We encourage the use of pre-submission meetings to approach the FDA with suggested labeling and conditions to see if a drug may be approved for nonprescription use.

For Further Information

If you have any questions about this Alert, please contact Frederick R. Ball, Carolyn A. Alenci, any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.