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The top line
: Two years after issuing draft guidance on “innovative” nonprescription drug labeling, FDA is again thinking about potential improvements to the Drug Facts Label.

First, let’s explain a bit about the regulation of labels for nonprescription drugs.

  • Nonprescription, or over-the-counter (OTC) drugs, are regulated differently than prescription drugs. Until recently, FDA relied on a monograph process, in which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and testing for the OTC products. However, under the March 2020 CARES Act, Congress replaced the monograph process with an administrative system intended to be faster and more simple. Instead of requiring FDA to issue and update monographs through notice-and-comment rulemaking, FDA now has the authority to regulate OTC products via an administrative process.
  • Labeling for nonprescription drugs has historically been outlined in each monograph. This means that these Drug Fact Labels (DFLs) are largely and procedurally uniform for all OTC products in a specific class, allowing for little deviation or additional information about the specific product that could support safe or effective use. Unlike labels for prescription drugs, which have the benefit of a clinician or provider assisting with patient comprehension, DFLs must be designed to be understood by regular patients. The main goal of a DFL is to help a consumer “appropriately self-select” an OTC product and use it “safely and effectively.”
  • Drug Fact Labels are currently standardized according to a March 1999 regulation. The rule was intended to make it easier to find drug information on a product’s label by standardizing the format and information provided. DFLs include information about the drug’s ingredients, intended use, any warnings (e.g., interactions with drugs, cautions about alcohol use) and directions for use. For safety purposes, the DFL should also include the drug’s expiration date, lot or batch code, name and address of the manufacturer, quantity and what a consumer should do in case of an overdose.

Now a newly announced workshop indicates that FDA might be looking to update Drug Fact Labels.

  • FDA is inviting academia and industry to the event to discuss “areas where improvements could be made to the format and content of the DFL.” Set to include both presentations and panel discussions, FDA is seeking to highlight barriers to consumer understanding of DFLs, including individual characteristics like health literacy and “trends in packaging that impact DFL effectiveness.”
  • Digital DFLs may be a priority as well. The agency states that it is looking for ways to enhance DFLs both as they are now in “traditional text/paper-based presentation” and also “adaptable for use with new technologies.” This likely includes digitally-available DFLs, as one of the topics outlined in the workshop announcement includes: “overcoming communication barriers through innovations to the DFL and developing DFL content for the digital space.” FDA has previously proposed regulating certain digital companion software for prescription drug (not OTC) use, referred to as “prescription drug-use-related software,” as labeling.
  • According to a 2018 literature review from researchers at the University of California, even as nonprescription drugs are widely used, a key challenge in DFL utility is that they are designed to be “static and non-customizable." This means that they cannot consistently meet specific needs for discreet populations such as older people, visually impaired people, or those with “pre-existing beliefs/attitudes that override DFL messaging.” Further, although DFLs are intended to be understandable to laypeople, making a decision to self-select a nonprescription drug product appropriately does require a person to consider “complex, multi-attribute criteria,” which are not well communicated in DFLs in their current form. That paper recommended the integration of more visual aids (e.g., iconography) into DFLs, as well as better used of technologies like interactive, step-by-step decision aids, multimedia content, flexible and customizable approaches and more accessible content (e.g., audio for the visually impaired). In addition, they further recommended increased reliance on pharmacists at the point of sale to help guide patient decisions and answer questions.

This isn’t the first time that FDA has looked to modernize DFLs.

  • In July 2018, the agency issued a draft guidance on “Innovative Approaches to Nonprescription Drug Products.” As the agency noted at the time, limitations with the DFL system “present challenges for adequate communication of information” necessary for safe use, especially for more innovative OTC drugs such as those that could help treat chronic conditions. “Approval of a wider range of nonprescription drug products has the potential to improve public health by increasing the types of drug products consumers can access and use that would otherwise only be available by prescription,” the agency explained. The guidance proposed that FDA could consider approving “additional labeling” beyond the DFL for certain OTC products, such as informational leaflets, interactive digital displays or website and/or mobile-app based informational portals, to support safe use when the DFL alone was not sufficient.
  • Reactions to the 2018 draft guidance were mixed. Pharmacy stakeholders were, to quote the National Association of Chain Drug Stores, “cautiously optimistic” about the proposal but raised concerns that the additional information beyond the DFL could inappropriately replace interactions with a health care provider. Pfizer supported the overall sentiment of the guidance, but urged FDA to consider a more tailored, risk-based approach than the broad flexibilities outlined in the guidance as drafted. Further, the Consumer Health Products Association (CHPA) urged FDA to go further, pointing to FDA’s 2018 announcement that it “intend[ed] to issue a proposed rule that provides more details regarding the use of additional conditions for nonprescription drug products.” However, the draft guidance was never finalized, and as of 2021 the proposed rule has not yet materialized.
  • Overall, 2021 is likely to be a big year for the nonprescription drug industry. The regulatory changes from the OTC reform, including the new user fee system and opportunities for exclusivity, are expected to be operationalized over the coming year. Further, industry is still anticipating new guidance on nonprescription drug naming, the draft version of which was issued in late 2020 (although FDA pushed the comment period back in March 2021). The workshop announcement specifically indicated that the agency is largely looking for discussions of how DFL content can be translated into digital spaces, including through apps, websites and interactive displays. However, it’s likely that the topic of “additional information” (separate from the DFL) proposals may be discussed at the meeting. Interested stakeholders can submit comments on the meeting docket through August 10, 2021.

The meeting will be held on June 9, 2021.

 

The preceding article is reprinted with permission from AgencyIQ, publishers of FDA TodayYou can sign up to FDA Today for free here.