A Teaching Moment for Next Generation Rx-to-OTC Switch: Updated

On Tuesday, June 28, 2022, FDA announced the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule outlines requirements for a nonprescription drug product that has an additional condition for nonprescription use (ACNU). The proposed rule intends to increase options for developing and marketing safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.

Amwell commends FDA on the proposed rule. It is consistent with all that the Agency has shared in prior guidance and industry discussions. It offers flexibility “regarding the types of additional conditions applicants may propose and how those additional conditions can be implemented.”

We stand by our position that the FDA has provided the industry with a roadmap for gaining approval for new nonprescription products. This pathway will unlock growth and value for sponsor companies.

Amwell is poised to support this new era of consumer empowerment and improved health equity.

FDA has placed a clinical hold on an actual use trial designed to evaluate the Rx to OTC switch of CIALIS, a treatment for erectile dysfunction. In the company’s recent press release, Sanofi said the pause is related to concerns about how the trial protocol has been designed, adding that no patients had so far been recruited for the study.

Much of the industry coverage of the announcement has suggested that FDA’s action will have a chilling effect on the ability of Sanofi and others to successfully switch many prescription drugs to over-the-counter status in the future.

We disagree.

As far back as 2012, FDA drew attention to the significant public health benefits that would accompany greater access to many treatments that currently require a prescription. The Agency stated that nonprescription access could help reverse the crisis of undertreatment of many common and some chronic conditions such as high blood pressure, high cholesterol, and asthma and relieve burdens on an already stressed healthcare system. At that time, FDA laid out a vision for using technology to aid consumers in selecting and using nonprescription drugs.

FDA had more to say on this in 2018 when it issued Industry Guidance entitled, “Innovative Approaches for Nonprescription Drug Products.” In its Guidance, FDA outlined “approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: (1) the development of labeling in addition to the DFL, and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product.”

FDA said that these approaches could lead to the approval of a wider range of drug products that consumers could safely and effectively use without the supervision of a health care practitioner.

Today, we have the technology, data interoperability, and consumer readiness to achieve FDA’s vision. And we can achieve this within the current regulatory framework by automating, connecting, and personalizing the tools of additional labeling and additional conditions for safety and effectiveness.

Our partners at Biograph have followed the FDA’s thinking on this issue since 2012. In response to the Agency’s vision, we submitted a Pre-Request for Designation (Pre-RFD) in 2017 that outlined a process to adapt data-driven safety standards operating in the Rx domain to deliver the same quality process in the OTC setting. This application set off a series of interactions and meetings with the FDA over the past five years as we crafted a technology-enabled approach to digital labeling for the next generation of nonprescription products.

Today, Biograph has partnered with Amwell to create a suite of Life Sciences solutions. The Amwell digital care platform offers sponsors a pathway to properly implementing a wholly new and empowering consumer self-care experience.

We do not know the specific issues that led FDA to their action on the Cialis program. However, Sanofi likely did not propose a comprehensive labeling strategy that included additional labeling and additional conditions sufficient to maintain the same safety provided to the public when purchasing Cialis on a prescription basis.

The FDA’s Innovative Approaches for Nonprescription Drugs Guidance suggests that sponsors leverage data and technology to interact with consumers and enforce label instructions. These additional conditions will improve the performance, reduce risk, and maximize the potential public health benefit.

We propose at least three considerations that a sponsor seeking to switch a prescription drug to nonprescription status should consider.

The first is objective verification of the consumer identity to ensure compliance with labeling regarding age, sex, and other instructions for use.

The second objective is a consumer-driven query of personal health attributes to check against label warnings. This safety process, powered by reliable third party data resources, identifies contraindications or drug interaction warnings for the individual consumer.

A third objective is to map a pathway for real-time access to a physician or pharmacist when label instructions direct the individual to “Ask a doctor before use” or “Ask a pharmacist.” This becomes an opportunity for retail collaboration to offer support in the consumer journey.

There are certainly other considerations that a sponsor and FDA will consider to ensure that nonprescription access carries the same safeguards as prescription access. A comprehensive labeling strategy for each nonprescription drug will reflect and address the risk profile of that product. Sponsors can approach each program with confidence that the vast capabilities and ecosystem connectivity of the Amwell digital care platform will help them address FDA requirements.

Rather than engaging in a “rush to judgment” that the FDA is not serious about enabling greater access to nonprescription treatments, Industry leaders should empower their organizations to evolve programs to meet the requirements outlined in the FDA’s Innovative Approaches for Nonprescription Drugs Guidance.

The FDA has provided the industry with a roadmap to the approval of new nonprescription products; and a pathway to offer consumers greater self-directed access to treatment. The requirements are reasonable, achievable, and within our grasp.

Amwell and its Biograph partnership are committed to helping sponsors act on FDA’s Guidance with innovative and comprehensive digital care capabilities that meet policy objectives and unlock value for consumer health.