(WASHINGTON, DC) – The Consumer Healthcare Products Association (CHPA) today released the below statement following the U.S. Food and Drug Administration (FDA) issuing a final rule for Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU):
“CHPA strongly agrees with principles included in the final rule that the use of technology to enhance consumers’ ability to self-select and use nonprescription (or over-the-counter [OTC]) products on their own can increase access and benefit public health. But we remain extremely concerned that the simultaneous marketing provision within the rule will blunt the incentive to pursue the ACNU pathway and would ultimately undermine public health goals. Moreover, we do not believe simultaneous OTC and prescription (Rx) status for identical products is permitted under the Food, Drug, and Cosmetic Act.
“For decades, Rx-to-OTC switches have increased access to safe and effective self-treatment options. This is why CHPA called on FDA to be extremely cautious to avoid unintended consequences from the ACNU rule as proposed in 2022.
“CHPA has additional concerns with the adoption of a ‘fail-first’ concept which will likely result in a significant increase for sponsors in development time and costs. We strongly believe sponsors should be able to evaluate the need for an ACNU in their switch or development programs without prior agreement from FDA.
“CHPA is disappointed that a number of our comments on the proposed rule were not reflected in the final rule. We continue to evaluate the rule and potential next steps.”
Click here to view CHPA’s Nov. 21, 2022, comments on FDA’s proposed rule on ACNU.
