Augmenting Labeling for OTC Drugs

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New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.

FDA has released for comments a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” which outlines ways that manufacturers could augment labels to demonstrate the safety and effectiveness of nonprescription drugs. 

Developed with the goal of making more low-cost, over-the-counter (OTC) treatments available to patients who suffer from chronic conditions, the guidance would govern nonprescription drugs submitted for approval via a new drug application (NDA) including those under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD&C Act).  The guidance would allow manufacturers to supplement drug facts labeling in cases where that labeling alone cannot ensure that patients will use the drug appropriately. 

In one option, additional information could be used to supplement the drug label and address areas of concern. Potential solutions would include information leaflets or other documents, video or interactive displays including text or images, website information, and statements or questions provided in a mobile health application.

FDA also states in the preliminary guidance that additional conditions could be set that consumers would have to meet in order to ensure safe drug usage. These conditions would be established before purchase of the drug, with purchase conditional on results. Possibilities could include:


  • Requiring consumers to respond to questions in a test on a mobile app, with test results indicating whether or not the consumer would be an appropriate candidate for the treatment

  • Requiring consumers to affirm that they viewed text or images in a video that describes how to use the nonprescription therapy properly.

Any methods selected would have to be tested and found to be effective before being included in an application, the guidance states. FDA acknowledges that these are only a few possibilities and suggests that NDA applicants carefully consider the treatment involved, key patient populations for the drug, and other factors carefully when coming up with alternatives.

As FDA Commissioner Scott Gottlieb acknowledged in a statement issued on July 17, 2018, when the draft guidance was released, “We envision this process will work as follows-a sponsor, for example one that has a prescription cholesterol-lowering drug or a prescription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. 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.”

Source: FDA