Skip to Content

Press Releases

Latta: Modernizing The OTC Product Approval Process

“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 (R-OH5) championed bipartisan legislation to reform the over-the-counter (OTC) monograph system with his bill, the Over-the-Counter Monograph Safety, Innovation, and Reform Act. This legislation was recently signed into law as a part of the CARES Act.

This law modernizes the monograph framework and allows new, safe products to come to market more quickly while addressing label changes and expanding consumer choice. It also allows the Food and Drug Administration to make scientific determinations for OTC ingredients through an administrative order process, which is much more efficient than the current rulemaking system.

Congressman Latta penned an op-ed in the American Healthcare Journal highlighting the importance of OTC monograph reform as we combat the coronavirus pandemic:

Rep. Latta: Modernizing The OTC Product Approval Process

April 22, 2020

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. …

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. …

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. 

To read the full op-ed in the American HealthcareJournal, click here.

Congressman Latta encourages anyone who needs assistance to contact his office in Bowling Green at 419-354-8700. Ohioans living in the Fifth Congressional District can also call 419-318-8925 to leave a message and Congressman Latta’s team will respond as soon as possible. For up-to-date information, visit Congressman Latta’s website at


Back to top