The FDA published the final rule for the much-anticipated additional condition for nonprescription use (ACNU) requirements on December 23, 2024. A nonprescription drug product with an ACNU is a drug product that can be marketed without a prescription if the applicant implements an additional condition to ensure the end user is making an appropriate selection and/or using the product appropriately without the supervision of a licensed healthcare professional. The final rule comes over two years after the initial rule was proposed and nearly 13 years since the FDA first gathered to examine a pathway to approve certain drugs for over-the-counter use that would otherwise require a prescription.
The final rule becomes effective on January 27, 2025, and aims to expand consumer access to safe and effective OTC drugs. The appropriateness of an ACNU product may be assessed through an FDA-approved questionnaire or a video followed by questions for the consumer. Successful completion of the additional condition (i.e. questionnaire) will satisfy competency for appropriate use. This could be seen as a milestone for patient empowerment, or a breaking of the dam that is safe and responsible medication use that pharmacists have spent their careers protecting.
ACNU certainly could provide more access to medications while avoiding costly copays and other direct and indirect costs. The FDA analyzed the time to see a doctor, obtain a prescription (including waiting time), and other transportation costs as well as copays and other out-of-pocket costs. Upon the conclusion of its analysis, the FDA estimates a $33.62 savings per consumer per purchase for patients who transfer from a prescription to an ACNU drug product. However, some stakeholders have raised concerns that payers and PBMs will cease any existing coverage of products once they are switched to ACNU status. This would shift payment to the consumer and could ultimately increase out of pocket costs.
Whether or not manufacturers will take advantage of this pathway to generate additional revenue remains to be seen. While the exact pathway to ACNU status for a drug is left vague by the FDA, manufacturers will have to submit an entirely new application. Some speculate that this could disincentivize and even limit the utilization of the ACNU pathway. The FDA would disagree. It cites that for drugs that have switched from prescription to OTC status, approximately 60 percent of drug purchasers are “new-to-therapy” consumers who had not taken the drug since it switched from prescription status. The FDA believes that this will create an opportunity to reach new markets for manufacturers who use the ACNU pathway.
This raises the question of whether or not a drug can be simultaneously marketed as a prescription and ACNU product. Will manufacturers have to completely abandon their prescription strategy for a product to pursue the ACNU pathway? The Food Drug and Cosmetic Act does not allow for the same active ingredient to be simultaneously marketed as prescription and nonprescription product unless a meaningful difference exists between the two that makes the prescription product safe only under the supervision of a practitioner licensed by law to administer such drug. The initial sentiment by the FDA is that an ACNU is a significant difference, just like strength or route of administration, that would allow for the same active ingredient to be simultaneously marketed in a prescription and nonprescription product. This means that manufacturers may be able to market the same product as prescription and as nonprescription with the only difference being that the nonprescription product has an ACNU.
The blurring of line between prescription and nonprescription products has sparked debate. Herein lies the argument posed by a great number of pharmacists, including those at the National Community Pharmacists Association (NCPA). Access to medication is important for patients. Some patients certainly could stand to benefit from ACNU products if manufacturers choose to pursue that route for their products. However, the NCPA would argue that ACNU products cut the pharmacist, whose primary responsibility is to ensure appropriate medications for their patients, out of the patient care process and therefore leaves the patient at risk for unnecessary adverse events. This is not limited to potential misuse of an ACNU product. Patients taking ACNU products could be at a higher risk of drug interactions going unnoticed compared to those who do not utilize ACNU products.
Other stakeholders may argue that the FDA is competent enough to separate prescription and nonprescription drugs, which pose many of the same risks. They would argue that there is no reason to believe that a product that could cause serious harm to a consumer would be designated as ACNU by the FDA in the first place and that pharmacists should conduct thorough medication reconciliations on patients to avoid interactions between prescription and nonprescription products.
Regardless which side you are on, the final rule becomes effective on January 27, 2025. It will be interesting to see if manufacturers pursue this new pathway and if patients prefer ACNU products over prescription products. It is also unknown what products and types of products will be approved for ACNU. Stay tuned!
Will ACNU pose a safety issue? Will there be unintended financial consequences because of ACNU? Will increased access to medications lower healthcare costs? Will manufacturers jump at the opportunity to market prescription and nonprescription products? How will payers and PBMs react to ACNU products? What products would be good candidates for ACNU? How will ACNU affect pharmacies? Share your thoughts with PHSL!