Political Quotes

“Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of H.R. 5333, the Over-the- Counter Monograph Safety, Innovation, and Reform Act. Over-the-counter medications are widely used to treat common ailments such as colds, headaches, and seasonal allergies. In fact, more than 240 million Americans use OTC products every year and trust these affordable remedies to get well and stay well. Despite the success and high utilization of these medicines, the Food and Drug Administration's regulatory framework for oversight of OTC products, also called the monograph system, is outdated and incomplete.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 the cumbersome notice and comment rulemaking process. I will give an example that was pointed out in committee that the FDA brought out. The FDA advanced notice proposed rulemaking for this one started on December 4, 1979. Through a process of 20 different procedures they went through, they got to November 19, 1997, almost 18 years later, and what do they do? They reopen the administrative records to consider new data. It is taking too long. That is what this bill would remedy. The lack of modernization makes it impossible for manufacturers to address safety concerns and offers little incentive to develop new products. H.R. 5333, which I introduced with the Health Subcommittee chairman, the gentleman from Texas (Mr.…”