(WASHINGTON, DC) — Today, the Consumer Healthcare Products Association (CHPA) echoed concerns in a letter sent to the U.S. Food and Drug Administration (FDA) by U.S. Reps. Bob Latta (OH-05), Debbie Dingell (MI-06), and Dan Crenshaw (TX-02), urging the Agency to ensure the simultaneous marketing provision of its proposed rule for Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU) is not included in a final rule:
“It is well established that the public health is benefitted when consumers have greater access to nonprescription drugs,” said President and CEO Scott Melville. "To that point, CHPA is pleased with the intent behind FDA’s recently proposed ACNU rule that could facilitate new non-prescription medicines coming to market. However, we remain extremely concerned with a provision in the proposed rule that would allow the same drug to be available simultaneously as both a prescription and nonprescription medicine. We believe such treatment would lead to significant consumer confusion, undermine the economic foundation of Rx-OTC switches, and is likely in conflict with the Food, Drug, and Cosmetic Act. The FDA should be extremely cautious of unnecessarily obstructing the Rx-OTC switch pathway, and we therefore hope the FDA strikes this provision when it issues its final ACNU rule. CHPA agrees with the points raised in today’s letter, and commends Reps. Latta, Dingell, and Crenshaw for urging FDA to remove the simultaneous marketing provision from its final rule, as it poses a threat to both consumers and the entire U.S. healthcare system by undermining the Rx-to-OTC switch process.”
“I’m proud of the work the House Energy and Commerce Committee has accomplished, including advancing my Over-the-Counter (OTC) Monograph Safety, Innovation, and Reform Act – signed into law in 2020 – to increase access to new safe pharmaceutical products for underserved communities,” Rep. Latta said. “Unfortunately, the FDA’s new rule of marketing both prescription and nonprescription versions of the same drug threatens this access and will limit innovation. That is why today, we are formally urging the FDA to remove the simultaneous marketing provision of their proposed rule that undermines the Rx-to-OTC switch process and poses a serious threat to the American consumer and our healthcare system.”
“We must continue to take meaningful action to expand access to nonprescription drugs and lower health care costs,” said Rep. Dingell. “However, I have concerns that the FDA’s proposed ACNU rule will counteract those efforts by disincentivizing the switch from prescription to over the counter, ultimately limiting access to important OTC medications.”
Click here to view CHPA’s Nov. 21 comments on FDA’s proposed rule on ACNU.