Opportunities and Challenges for Advancing Non-Prescription Medicines

FDA officials are proposing new rules, beefing up regulatory resources, and promoting digital technologies to support the development and marketing of safe and innovative over-the-counter (OTC) therapies. The agency and manufacturers continue to hope that Congress will approve legislation authorizing new user fees to modernize the OTC monograph review program, a plan that has been high on the legislative agenda for several years. But even without final agreement on that reform initiative, officials at the Center for Drug Evaluation and Research (CDER) expect to establish an expanded review office for nonprescription drugs as part of a broader reorganization of the Office of New Drugs (OND). In addition, the revamped office will better manage new drug applications (NDAs) for non-prescription medicines, including the new Nonprescription Safe Use Regulatory Expansion (NSURE) initiative to facilitate switches of prescription therapies to nonprescription status.

“OTC monograph reform remains a top priority for the agency,” stated FDA Chief of Staff Lauren Silvis at the recent meeting of the Consumer Health Products Association (CHPA). She described agency plans to facilitate prescription-to-OTC switches to increase consumer access to medicines that can be used safely without a prescription. Draft guidance issued in 2018 should encourage manufacturers to provide additional information on proper product use than what is found in the approved drug facts label (DFL).

CDER also is working to finalize a proposed rule for developing and marketing OTC sunscreens, an issue that has raised a host of issues relevant to ensuring safe and proper use of these widely available products. FDA seeks additional data to document the safety of ingredients commonly used in sunscreens that can be absorbed in ways to possibly have systemic effects on the body.

FDA also is concerned about dietary supplements made with unlawful ingredients or promoting violative claims. An agency initiative aims to communicate information on new ingredients in supplements that FDA has not yet determined to be safe and legal, while also seeking further input on efforts to encourage “responsible innovation” in supplement marketing.

In all these initiatives, FDA looks to utilize new technology that enables manufacturers to ensure the safe use of products beyond approved labeling. Silvis noted that new digital health technologies such as mobile applications and in-store digital kiosks can help consumers understand where additional conditions can be treated with an OTC product and facilitate consumer self-selection of treatment.

Considering cannabis

Of great public interest is FDA’s recently launched review of appropriate regulatory approaches for assessing the safety, risks, and benefits of foods, dietary supplements, and therapies with cannabidiol (CBD) ingredients. The agency seeks to gain scientific information that can help it evaluate how to oversee cannabis and cannabis-derived compounds at a public hearing held May 31, 2019, which has attracted hundreds of speakers and comments.

This initiative arose from Congressional approval of legislation in late 2018 that removed hemp from the federal controlled substances list, launching a stampede to market products made or infused with CBD. The measure also authorized FDA to examine how its authorities apply to CBD products, Silvis explained, and what “scientific uncertainties” should be addressed for legal marketing. FDA aims to protect the public from unsafe or ineffective products, including those that make unproven disease claims.

One issue is whether it is appropriate to use CBD in cosmetics or dietary supplements.  FDA is looking for “reliable scientific research” on health and safety risks, on how standards or processes can help ensure product quality, and what kind of policies may address marketing, labeling, and sales issues. By seeking input from a range of stakeholders, Silvis added, FDA aims to “clarify our regulatory authority over these products” and to make “sound, science-based decisions to protect the public’s health.”

After hearing from nearly 150 interested parties at the public hearing, an FDA cross-agency working group of senior staff will review both oral and further written comments on these issues. Meanwhile, Silvis advises manufacturers to hold off on submitting applications that look to claim a CBD product as a new dietary ingredient.