Political Quotes

“I thank the gentleman from Texas for yielding to me. Mr. Speaker, I rise in support of H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, and I want to thank Chairman Walden and Ranking Member Pallone for bringing this important bill to the floor. The monograph system for regulating over-the-counter drugs is broken, plain and simple. Mr. Speaker, 60 percent of all medicines sold in the United States are over the counter, yet the FDA only has 18 full-time employees overseeing the market. It doesn't work for patients; it doesn't work for companies; and it doesn't work for the FDA. Companies cannot bring new, innovative products to market and the FDA cannot act quickly when they are faced with a safety risk. This is not reflective of how our healthcare system should be run, and it is putting patients at risk. Our legislation helps bring the agency into the 21st century by creating a user fee program at FDA for OTC drugs and by making it easier to bring a new, innovative product to the market. From past experience, we know that user fee programs have been very successful at FDA, and this bill extends that successful model to the OTC space. Today, the FDA has to go through the cumbersome rulemaking process to update a monograph, which is problematic for many different reasons.…”