WASHINGTON — The Consumer Healthcare Products Associatioh today released a statement echoing concerns U.S. Representatives Bob Latta (R-OH), Dan Crenshaw (R-TX), and Mariannette Miller-Meeks (R-IA) raised to the U.S. Food and Drug Administration, 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).
Last month, the FDA announced a further two-month delay in implementing the ACNU final rule, which is now scheduled to take effect on May 27. This follows the initial delay announced 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. According to the CHPA, this is an unnecessary topic in this context and why it calls for the FDA to remove the simultaneous marketing discussion from the preamble, as it will avoid unintended precedent and preserve a practical path forward.
Statement in full:
“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.”
