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Over-The-Counter Monograph Safety, Innovation, and Reform Act of 2018

Floor Speech

Date: July 16, 2018
Location: Washington, DC
Issues: Health and Health Care

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Ms. DeGETTE. Mr. Speaker, today we have an opportunity to make long- overdue reforms to the way that the FDA reviews over-the-counter medicines. These medicines play a critical role in treating Americans' ailments and in helping us stay healthy. In fact, almost 7 in 10 parents report giving their kids OTC medicine to help treat sudden medical symptoms. Similarly, 81 percent of adults use these drugs as a first response to treat a minor ailment.

Think about it. Despite the widespread use of over-the-counter medicines, the FDA is currently forced to use a cumbersome and laborious monograph pathway to approve them. This antiquated, 40-year- old OTC review system has not kept pace with new medical advances and the rapid expansion of this market, which now comprises over 300,000 drugs. As a result, the current monograph review system fails to respond to the OTC safety issues in a timely and effective way, which can pose serious healthcare risks for children and families.

Between 2004 and 2005, for example, the Centers for Disease Control and Prevention reported 1,500 cases of children under the age of 2 visiting emergency rooms due to serious side effects or overdoses associated with over-the-counter cough and cold products.

Since the CDC made this startling finding, the FDA has been trying to revise the cough and cold monograph system to warn parents about the risks that these common drugs can pose to children, but the FDA can't do it because they have been hamstrung due to the burdensome process it must undergo to revise these monographs.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act would streamline the FDA's review of over-the-counter drugs and provide it with new tools to protect children and warn parents about potentially dangerous OTC drugs.

I want to add my thanks to the bipartisan team that passed this bill, Representatives Latta, Burgess, Green, Guthrie, and Dingell for all working together with me on this important legislation, and, in addition, Ranking Member Pallone, Chairman Walden, the FDA, and the many stakeholders that have worked closely with us throughout the process.

Mr. Speaker, the bill is a rare triple win for regulators, consumers, and industry. I urge my colleagues' support.

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