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

Floor Speech

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Mr. LATTA. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5333) to amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes, as amended.

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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Food and Drug Administration's regulatory framework for oversight of OTC products, also called the monograph system, is outdated and incomplete.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. Burgess); the Health Subcommittee vice chairman, the gentleman from Kentucky (Mr. Guthrie); the Health Subcommittee ranking member, the gentleman from Texas (Mr. Gene Green), the gentlewoman from Colorado (Ms. DeGette); and the gentlewoman from Michigan (Mrs. Dingell) would provide meaningful and long overdue reform to FDA's monograph system.

The necessary reforms would create a more flexible framework that accounts for advances in science, permits timely updates to safety information and label changes, and creates a workable process for completing unfinished monographs.

By updating the current burdensome process, Congress would also create a pathway to market for new and innovative products that greatly benefit our constituents and reduce strain on our healthcare system.

Safe, reliable, and affordable OTC drugs allow consumers to treat common ailments at home, usually without visiting a healthcare provider, saving the healthcare system $102 billion annually.

Our bill would improve regulatory certainty for manufacturers and, over time, we would see additional investment in research and development, leading to new, innovative OTC medicines that will continue to save Americans and our healthcare system money.

I thank my colleagues, FDA, and stakeholders for working so closely with me over the last 2 years to ensure that this modernization effort appropriately addresses and resolves this complex issue.

I strongly urge my colleagues to support passage of H.R. 5333 to modernize the broken monograph system, strengthen consumer protection, spur innovation, and increase consumer choice.

Mr. GENE GREEN of Texas.

Mr. Speaker, I rise today in support of H.R. 5333, the Over-the- Counter Monograph, Safety, Innovation and Reform Act.

I am a proud original cosponsor of this legislation that will strengthen the Food and Drug Administration's ability to oversee the over-the-counter drug market and establish a user fee program for this market for the first time.

H.R. 5333 is legislation that enjoys bipartisan support and would reform the current monograph system that is relied upon by industry to legally market over-the-counter drugs in response to concerns raised by both the FDA and the industry that the current system is outdated and burdensome.

Under current law, the safety and effectiveness of over-the-counter drugs is established through conformance with a monograph. Monographs serve as a type of rule book outlining the conditions of use for a particular drug ingredient, including the dosage form, patient population, labeling and warnings, and other requirements. This rule book is established currently through a three-phase rulemaking process and is very resource and time intensive.

This process has made it difficult for the FDA to finalize, revise, or update monographs to reflect innovations, changes in science, or to respond to safety issues.

We also have heard from the industry that the current process inadvertently discourages innovation, as it is not nimble enough to respond to evolving science and technology.

The legislation we are considering today would address these concerns by transitioning the monograph system from rulemaking to administrative order, create a procedure for the FDA to respond to the needs for safety label changes, and establish an innovation pathway.

These reforms can only be successful if it is also accompanied by stable and reliable funding that more appropriately represents the growth and science of the over-the-counter industry.

Today, the over-the-counter monograph program oversees more than 100,000 products with a staff of about 30 people and a budget of just over $8 million. The user fees provided in this bill would help the FDA transition the monograph program from rulemaking to administrative order, provide for additional staff capacity, and enable the FDA to respond to innovation and safety changes in the current market.

I want to thank my colleague from Ohio, Congressman Bob Latta, for introducing this legislation and for working with me and other members of our committee. I would like to thank the original cosponsors of the bill, Representative Diana DeGette, Representative Debbie Dingell, Chairman Mike Burgess, and Representative Brett Guthrie for their dedication and hard work on this important issue.

I ask all my colleagues to join me in supporting the Over-the-Counter Monograph Safety, Innovation, and Reform Act.

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Mr. LATTA. Mr. Speaker, once again, I just want to thank all the members for all their hard work on this. Especially, I want to thank the gentleman from Oregon, the chairman of the full committee, for his work on this piece of legislation. Also, I want to thank the staff.

Mr. Speaker, I urge passage of the bill.

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