As the FDA begins to review and approve applications for marketing these drugs, manufacturers will need to follow new requirements.
In late December 2024, the U.S. Food and Drug Administration issued its new rule establishing requirements for approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU), aiming to increase the availability of certain drugs directly to consumers and increase options for manufacturers to develop and market safe and effective nonprescription drugs. The final rule is scheduled to become effective in March 2025.
A nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if the manufacturer implements an “additional condition” to ensure appropriate self-selection (consumers being able to choose whether the drug is right for them), appropriate actual use, or both, by consumers without the supervision of a healthcare provider.
Overview of the ACNU Final Rule and Compliance
Many categories of drugs have transitioned from prescription to over-the-counter (OTC) in recent years, including many allergy medicines, the morning-after pill, opioid overdose reversal medication and laxatives, among others, after demonstrating that they are safe and effective without physician oversight. Despite the move of some of these drugs to OTC, other drugs have remained available as prescription-only—including some that manufacturers and the FDA believe should be accessible OTC—such as antibiotics, statins, albuterol inhalers, insulin and more, subject to certain conditions.
Now, the final rule on ACNU drug products will allow a drug sponsor (the entity or applicant developing a nonprescription drug product) to switch its prescription drug to being available OTC, or to head straight to the OTC market, provided the sponsor can demonstrate certain criteria. Namely, the sponsor must demonstrate that safety issues not addressed by the OTC drug facts are addressed by an additional condition. An example of an “additional condition” could be a questionnaire to determine if the drug product is right for the consumer, and then dispensing the product through a pharmacy or from a designated locked kiosk.
As the FDA begins to review and approve applications for marketing these drugs, manufacturers will need to follow new requirements. The rule requires manufacturers seeking approval for nonprescription drugs with ACNUs to submit applications with additional information beyond the traditional new drug application requirements. For example, applicants must submit both the purpose and necessity of labeling their product ACNU, data about the product, labeling information and operational plans regarding how the approved conditions will be satisfied in order to obtain ACNU approval. While the required application information largely supplements the requirements for a new drug application, the final rule does require a separate application for a nonprescription drug product with an ACNU, and sponsors cannot merely supplement an existing new drug application.
Potential Impacts
The new rule is not intended to affect drugs already marketed as nonprescription. But it does open the door for manufacturers to submit separate applications for nonprescription drug products with ACNUs that may not otherwise qualify for OTC marketing. This will increase marketing options for sponsors and increase availability of certain drugs to consumers. Indeed, the FDA’s stated goal in establishing this framework was to extend access to drugs to the public that treat both chronic and acute conditions.
In turn, the final rule will undoubtedly have impacts on manufacturers and consumers alike. As an initial matter, manufacturers who pursue this route will need to follow the regulatory requirements governing the submission of these new applications. They will also need to comply with new labeling requirements for ACNUs—which must appear in bolded text on a yellow background to help distinguish products with ACNUs from those without them, for example. The rule also includes specific post-marketing requirements, including a 15-day window to report “ACNU failures,” which include operational issues and issues related to key implementation requirements. Consumers in turn will need to satisfy the additional condition(s) required to purchase nonprescription drugs with ACNUs, which they will need to be aware of and comply with prior to purchase, as compared to traditional OTC product purchases. Manufacturers will need to include specifics on an operational plan for satisfying these conditions on the consumer end, which may entail cooperation with retailers to ensure that conditions are satisfied prior to product purchase.
Product Liability Considerations
The final rule also raises potential product liability considerations for manufacturers. For example, nonprescription drugs with an ACNU are by definition not appropriate for all consumers and eliminate the role of the provider in assessing attendant patient risks. To this end, while the consumer purchasing a nonprescription drug with an ACNU must attest they meet the additional condition, there remains a risk that consumers will misunderstand or incorrectly attest to being within the appropriate patient population. This may enable consumers to self-prescribe—either intentionally or inadvertently—against product warnings, whereas medical providers can short-circuit prescriptions where not properly indicated. While of course product misuse provides a defense in matters, it will have to be litigated as a factual issue, and without the benefit of the learned intermediary defense for ACNU products.
On the flip side, under the final rule, ACNU drug labeling will be subject to FDA’s review in the product application and—given this oversight—the argument for preemptive effect of a ACNU product’s labeling may have more force than has traditionally been recognized in the OTC drug context. The viability of potential preemption defenses to labeling claims in this context will remain to be seen as ACNU cases arise.
Additionally, depending on the method for executing the ACNU requirements, there may be greater litigation and indemnification issues with retail distributors tasked with ensuring compliance with the additional conditions before products are purchased, and as to retailers who are named in litigation and sold the product consistent with the ACNU requirements—should resulting claims arise. Manufacturers and retailers alike should consider the best methods for retention of data to verify satisfaction of specified conditions prior to product sales to ACNU customers.
Conclusion
Under the rule, manufacturers have the potential to more widely distribute certain drugs to consumers without a prescription, so long as the consumer satisfies an additional condition. Given the opportunities to more widely market ACNU drugs directly to consumers, manufacturers should be aware of the corresponding requirements and potential risks involved, including with respect to regulatory compliance, potential patient safety issues and related litigation. Drug manufacturers should familiarize themselves with these requirements when evaluating whether to apply for approval under the rule, and to ensure proper execution of marketing strategies for ACNU drugs, which may entail strategic coordination with retail pharmacies and distribution centers.
For More Information
If you have any questions about this Alert, please contact Dana J. Ash, Alyson Walker Lotman, Sharon L. Caffrey, Anne A. Gruner, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Products Liability and Toxic Torts Groups, or the attorney in the firm with whom you are regularly in contact.
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