Over-the-counter (OTC) medicines are necessities for nearly every American. From the treatment of cold symptoms and allergies to stomach ailments and headaches, there are over 100,000 OTC options from which consumers can choose to treat or manage a variety of symptoms and conditions. In fact, the majority of medicines on the market today — 60 percent — are available over the counter. Most of these medicines are regulated by the U.S. Food and Drug Administration (FDA) under what’s called the OTC Monograph system. However, despite the popularity and widespread availability of OTC medicines, the OTC Monograph system hasn’t been updated in more than 40 years.
Currently the FDA establishes standards for an OTC therapeutic drug class by reviewing the active ingredients in the product to determine whether the ingredients are safe for use in self-treatment. As prescription drug prices continue to rise, more Americans are turning to OTC medicines to self-treat certain conditions. When the FDA needs to make updates to an existing monograph based on new science and data, the process is cumbersome and antiquated, and it can take months if not years to complete. It also significantly delays the availability of new products that are proven to be safe and often are more effective due to advances in medical science and technology. This outdated OTC Monograph system has real-life implications on the future quality and quantity of products available to consumers.
Making OTC Monograph improvements now is essential to creating a modern, safe, and streamlined regulatory framework to benefit consumers and public health. Members of both the U.S. Senate and House are considering language on monograph reform. It is critical that this effort maintains momentum within Congress, as it would greatly improve OTC Monograph efficiency, transparency, and predictability; spur more innovation; accelerate safety labeling changes; and finalize the remaining 20 percent of monographs that are unfinished today.
As a veteran of the OTC healthcare space, I have firsthand experience with the limitations of the current OTC Monograph system. For example, when developing a new product for dry eye, scientists developed a product with a new lubricant that was not approved under the OTC Monograph, but was equally safe and considerably more effective than approved lubricants already on the market. As a result, the innovative technology was allowed in Europe and Asia, but not in the U.S. Because of our antiquated Monograph system, innovative companies with ideas for new and better OTC products find it very unwieldy and expensive to bring new safe and effective products to market when the modern technology does not align with a regulatory system designed decades ago.
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Healthcare organizations and individuals across the U.S. have been vocal in their support for OTC Monograph modernization at both the national and local levels. The bipartisan momentum behind OTC Monograph reform in both the House and Senate is encouraging consumers, alongside industry stakeholders, to see it forward. This is a simple healthcare improvement issue that has wide bipartisan support as well as support from industry, healthcare professionals, and public health experts.
It is imperative that we call on Congress to encourage them to modernize the outdated OTC Monograph system as quickly as possible. Our communities rely on OTC medicines for everyday care, especially in the ever-changing environment of healthcare in our country. Over the past 40 years, the federal government has improved the process of many regulatory guidelines in our country including healthcare, taxes, insurance, information technology, campaign finance, elections, trade, government oversight, and more. The regulatory system that regulates OTC medicines — the majority of medicines Americans use — deserves the same.
Elyse Stoltz Dickerson is the CEO and co-founder of Eosera®, a Fort Worth-based company. Eosera is a majority woman-owned biotech company committed to developing products that address underserved medical needs. Eosera seeks to heal humans through innovative healthcare products.