Rep. Latta: Modernizing The OTC Product Approval Process

How do we better address public health issues, provide economic relief or supplement the heroic efforts of our private sector to combat a crisis like the one we are facing now with the coronavirus pandemic? Congress is addressing these obstacles through legislation.
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How do we better address public health issues, provide economic relief or supplement the heroic efforts of our private sector to combat a crisis like the one we are facing now with the coronavirus pandemic? 

Congress is addressing these obstacles through legislation. 

Recently, Congress passed the CARES Act, legislation to help those affected by this crisis through direct payments, small business loans and grants, and support for our nation’s healthcare providers. The CARES Act also includes a bill that I’ve long championed that will make it easier for Americans to protect themselves against COVID-19 by reforming and modernizing the way over-the-counter (OTC) products are approved by the U.S. Food and Drug Administration (FDA).

Nearly all Americans purchase OTC products regularly, and we’ve seen just how important they can be to help prevent the spread of COVID-19 and treat those who are afflicted. With OTC products like hand sanitizer playing an important role in helping people stay safe, approval of these products should be quick and streamlined. The traditional FDA process for OTC drugs and products is too burdensome, doesn’t use the most up-to-date science and limits the development of new OTC options. That’s why making this fix now was so important. 

Here’s where this system, the OTC monograph process, went wrong. In the 1970s, the FDA put in place an approval apparatus where OTC products could be approved based on an active ingredient or combination of ingredients that are considered to be safe and effective. A number of these “monographs” have never been finalized even though it is now decades later. While OTC products currently on your shelves are safe, this incomplete system has meant uncertainty for manufacturers leading to a lack of new and innovative products for consumers. Even though common products like headache medicine, bandages and allergy relief are used every day, the approval process to change their labels or delivery mechanism was woefully cumbersome and out of date. 

Reforming the OTC monograph system has been a long time coming and has seen Republicans working hand in hand with Democrats to address the problem. After countless bipartisan discussions, I introduced the Over-the-Counter Monograph Safety, Innovation and Reform Act and garnered the backing of manufacturers of OTC products, consumer groups and officials at the FDA. 

Despite receiving widespread support in Congress, the legislation did not become law right away. In fact, it needed to pass the House four times before it became law as part of the CARES Act. Getting this bill across the finish line took longer than anticipated, but its passage was a real turning point. This tool will now help the FDA streamline the approval of new OTC medicine and products that Americans desperately want and need.

The legislation ends the current practice of requiring OTC drug monographs to go through a burdensome rulemaking process that takes far too long. Additionally, the bill makes it easier to update products on the market today using the latest scientific or safety information without needing to go through the cumbersome rulemaking process. It’s hard to believe, but the previous process actually discouraged using the newest science because of the bureaucratic hoops that would be required for approval. That problem now is solved.

Over the last few weeks, we’ve seen the heroics of our healthcare workers on the front lines. We’ve seen communities coming together to support their friends and neighbors who have been affected the most by this pandemic. We’ve seen businesses and manufacturers completely revolutionize their production lines to help in the fight against the coronavirus. Americans have been united and have shown their resiliency. 

Congress needs to ensure that the laws and rules on the books don’t hinder these efforts. Reforming the way OTC products are made is one way we’ve reduced barriers to innovation and provided certainty for consumers. More innovation and competition mean better products and lower costs for American families. This will pay dividends as we seek to win the fight against COVID-19, and it also will benefit us well into the future. 

Congressman Bob Latta represents Ohio’s 5th Congressional District. He is a member of the House Energy and Commerce Committee and serves as Republican Leader of the Subcommittee on Communications and Technology.

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