On the recordDecember 10, 2019
Madam President, today, the Senate passed S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, which will completely overhaul and improve how the Food and Drug Administration--FDA--regulates over-the-counter--OTC--or nonprescription, drugs. These medicines are used by Americans every day, but our regulatory system has been stuck in the 1970s and has not kept pace with innovation or the need to ensure appropriate consumer protections. Senator Johnny Isakson and I have been working on this legislation since 2016. This legislation creates a modern regulatory system for OTC drugs, providing the FDA with new resources to be able to review changes to existing OTC drugs and allow the marketing of new OTC drugs. FDA will have the authority to take swift action to protect the American public if a serious problem arises and to make changes to how OTC drugs are allowed to be sold if the science indicates that the steps are necessary to ensure that these products are used safely. The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 establishes a streamlined administrative process which allows the FDA to modify a drug's safety labeling to address new health risks. The act is intended to modernize and accelerate regulatory procedures applicable to OTC drugs and will also allow for increased innovation. However, patient safety and manufacturer accountability are of equal importance.…





