(WASHINGTON, D.C.) — The Consumer Healthcare Products Association (CHPA) today released the following statement echoing concerns U.S. Reps. Bob Latta (OH-05), Dan Crenshaw (TX-02), and Mariannette Miller-Meeks (IA-01) raised to the U.S. Food and Drug Administration (FDA), urging the Agency to strike the simultaneous marketing portion of the preamble that is tied to the final rule for Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU):
“It cannot be emphasized enough how vital expanded access to OTC medicines is to public health, and the Rx-to-OTC switch process has delivered safe, effective, and affordable options for decades. In fact, the Office of Management and Budget estimates that future Rx-to-OTC switches could save consumers nearly $27 per purchase. While the new rule enabling these switches through modern technology is a promising step forward, CHPA is concerned the rule’s preamble unnecessarily raises issues about simultaneously marketing prescription and nonprescription versions of the same product—an issue that doesn’t belong in this context. We strongly urge FDA to protect the trusted Rx-to-OTC switch pathway while advancing the broader benefits of ACNU, and we commend Reps. Latta, Crenshaw, and Miller-Meeks for championing greater access and choice for consumers.’”
Background:
Last month, FDA announced it was delaying the implementation of the ACNU final rule for another two months, now set to take effect May 27, following the announcement of its initial delay in January.
The preamble portion of the Federal Register notice describing the ACNU final rule includes a discussion on the simultaneous marketing of prescription and nonprescription versions of the same product—a topic that is unnecessary in this context. This is why CHPA is calling for FDA to remove the simultaneous marketing discussion from the preamble, as it will avoid unintended precedent and preserve a practical path forward.
