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

Floor Speech

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Mrs. DINGELL. Mr. Speaker, 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. Not only does it make it harder for innovative products to come to market, but it also makes it nearly impossible for the FDA to amend existing monographs if they see safety concerns in certain products.

We need to make sure FDA has the ability to act quickly if they see unsafe products in the market, and our legislation makes it easier for the agency to do so. This is why the bill has the support of industry groups and consumer groups.

Mr. Speaker, I know that there has been much discussion about the exclusivity provisions of this legislation. It has been debated in committee, and we compromised with 18 months of exclusivity. I will be the first to admit it is not perfect, but, on balance, the public health benefits of this bill outweigh any concerns about exclusivity.

Americans deserve to have the most innovative products on the market available to them, while ensuring the FDA has the resources they need to protect public health. I am proud to say that this legislation accomplishes both these goals.

I, too, want to thank my colleagues, Bob Latta, Diana DeGette, Brett Guthrie, Gene Green, Dr. Burgess, Chairman Walden, and Ranking Member Pallone for all their hard work on this legislation. Their staffs worked tirelessly as well on this, and I want to thank all of them for their efforts.

Passage of this bill represents another step towards getting our legislation signed into law this year. I urge my colleagues to support H.R. 5333.

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