Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

Floor Speech

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Mr. LATTA. Mr. Speaker, I rise today in support of H.R. 269, the PAHPA OTC legislation, which includes a bill I authored last Congress, the Over-the-Counter Monograph Safety, Innovation, and Reform Act.

More than 240 million Americans use over-the-counter medications for relief of common ailments, such as headaches, colds, and seasonal allergies. We trust and depend on these affordable remedies to get us well and stay well.

Despite the success and high utilization of these medicines, the Food and Drug Administration's regulatory structure for oversight of OTC products, referred to as the monograph system, is outdated and incomplete. The system was created more than 45 years ago, yet movement on unfinished items has ground to a halt due to cumbersome notice and comment rulemaking processes.

Without process modernization, it is nearly impossible for manufacturers to address safety concerns and offers little incentive to develop new products. This bill would provide meaningful and long overdue reform to the FDA's monograph system. The reform will create a more flexible framework that accounts for advances in science, allows timely updates to safety label changes, and creates a workable process for completing unfinished monographs.

This bill would also create a pathway to market for new and innovative products, which would help to reduce strain on our healthcare system by giving consumers more options to treat common ailments at home. Furthermore, this legislation will improve regulatory certainty for manufacturers. Over time, we would see increase investment in research and development, leading to new OTC medicines on our shelves, and providing greater self-care options to consumers.

Again, I thank my colleagues--Ms. DeGette, Mr. Guthrie, Mrs. Dingell, Dr. Burgess, and former Member Mr. Gene Green from Texas--the FDA, and stakeholders for working so closely with me over the last 3 years to ensure that this modernization effort appropriately addresses and resolves this complex issue.

I believe modernization of the broken monograph system will strengthen consumer protections, spur innovation, and expand consumer choice. It is long overdue to fix this regulatory framework that oversees 60 percent of the medicines sold in the United States.

Mr. Speaker, I strongly urge my colleagues to support passage of our bipartisan bill, H.R. 269, PAHPA OTC.

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