(WASHINGTON, D.C.) — The Consumer Healthcare Products Association (CHPA) applauds the Energy and Commerce Committee, particularly Chairman Fred Upton (R-Mich.), Ranking Member Frank Pallone (D – N.J.), Health Subcommittee Chairman Joe Pitts (R-Penn.) and Ranking Member Gene Green (D-Tex.), Representative Diana DeGette (D-Colo.) and all members of the Committee on House passage of the 21st Century Cures initiative (H.R. 6). CHPA looks forward to implementation of these provisions and believes it will help accelerate the discovery, development, and delivery of new treatments and cures for patients, including over-the-counter (OTC) medicines. Leadership in the U.S. House has been critically important in the drafting and passage of this important legislation, and CHPA looks forward to next steps working with the Senate.
In particular, the focus on patient-focused drug development is of key importance to the OTC industry, as outlined in Section 2001 of H.R. 6, which would require FDA "to establish a structured framework for the meaningful incorporation of patient experience data into the regulatory decision-making process."
This section would provide more structure through FDA guidance for patient-reported outcomes, including in clinical trials and drug submissions. It presents an opportunity to accelerate trends in how companies look at patient-reported outcomes in their prescription(Rx)-to-OTC switch applications. Rx-to-OTC switch refers to the transfer of proven Rx drugs to nonprescription, OTC status. Rx-to-OTC switch is a data-driven, scientifically rigorous, and highly regulated process that allows consumers to have OTC access to a growing range of medicines. More than 100 OTC ingredients, strengths, or indications on the market today were available only by prescription less than 40 years ago — and we believe this trend will continue as consumers demand greater control of their healthcare.
We also commend Section 2062 of H.R. 6, which outlines expansion of FDA’s ability to make decisions regarding therapeutic benefit based on real-world evidence, including observational studies, registries, or patient reported outcomes. This evidence would be used as a supplement to randomized controlled trials, as appropriate, and could have significant benefit for patients and other stakeholders. This development could be very helpful in expanding the sources of data to demonstrate safe use and the benefits of new medicines, including OTCs.
We appreciate the efforts of the U.S. House of Representatives to improve upon the value of OTC and prescription medicines to patients and the healthcare ecosystem, and we look forward to the bill’s next steps as it moves to the Senate for further consideration.
