(WASHINGTON, DC) — The Consumer Healthcare Products Association (CHPA) released the following statement today after submitting comments to the U.S. Food and Drug Administration (FDA) on its proposed rule for Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU):
“CHPA appreciates the opportunity to provide feedback to FDA regarding the proposed ACNU rule and is supportive of the Agency’s efforts to improve public health through increased access to nonprescription drugs. While we agree with many of the principles to increase consumers’ ability to self-select and use products on their own, we remain concerned with three key aspects that would impose overly burdensome reporting requirements and create unnecessary obstacles for both FDA and application sponsors.
“First, CHPA is concerned that simultaneous marketing of the same Rx and OTC product with an ACNU would ultimately limit rather than expand access for underserved communities, while also undermining the rule’s anticipated favorable economic impacts. For decades, Rx-to-OTC switches have proven to increase access to safe and effective self-treatment options, and we should be extremely cautious of any actions that could disincentivize manufacturers from pursuing this pathway that benefits consumers and the healthcare system.
“Second, putting the onus on the sponsor to prove the need for an ACNU through the adoption of a ’fail-first’ concept, would not only trigger a significant increase for sponsors in time and costs for development, but it could be interpreted as needing prior approval from FDA to study an additional condition. CHPA strongly believes sponsors should be able to evaluate the need for an ACNU in their switch or development programs without prior agreement from FDA.
“Finally, the proposed changes related to adverse event reporting could negatively impact the ability to detect a true safety signal arising from an ACNU. Instead of implementing excessive and unnecessary requirements, CHPA believes FDA should utilize existing adverse event reporting systems, and we have provided recommendations in our comments to improve their effectiveness.”
Click here to view CHPA’s full comments.