FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that sponsors of new drug applications may wish to consider to demonstrate the safety and effectiveness of nonprescription drugs.  In announcing the draft guidance, FDA Commissioner Scott Gottlieb explained that the agency sees an opportunity to “foster greater access to the medicines that help keep people healthy” by encouraging “innovative tools, like digital health technologies, that would support consumers in appropriately and safely self-selecting and using certain drugs.”

While reiterating that the legal standard for approval of new drugs as nonprescription drug products remains the same under section 505 of the Federal Food, Drug & Cosmetic Act, the draft guidance identifies two specific innovative approaches that “could lead to the approval of a wider range of nonprescription drug products, including drug products that may treat chronic conditions or other conditions for which the limitations of the DFL [drug facts labeling] present challenges for adequate communication of information needed for safe and effective use without the supervision of a health care practitioner.”  Those two approaches are:

  • Labeling in Addition to the DFL for Nonprescription Drug Products.  The draft guidance explains that FDA may approve additional labeling for nonprescription drug products and cites as potential examples information leaflets, text or images on a video display or interactive displays, information displayed on websites, and statements or questions on a mobile application.
  • Nonprescription Drug Products With Additional Conditions for Safe and Effective Use.  The draft guidance suggests that new drug sponsors may wish to propose additional conditions that consumers must fulfill to ensure that the product is safe and effective for nonprescription use, such as requiring the consumer to respond to a set of questions on a mobile application or affirm that they’ve seen a video describing how to appropriately use the drug.  The draft guidance further notes that “applicants should consider how to ensure proper implementation of any additional condition necessary for safe and effective use.”

Comments on the draft guidance will be accepted until September 17, 2018.  Commissioner Gottlieb noted that the agency views the draft guidance as “a first step as drug developers begin to study products that might be considered for marketing without a prescription.”  As noted in Commissioner Gottlieb’s statement accompanying the draft guidance, the agency also intends to initiate a rulemaking that 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.”