Congress Passes Legislation to Reform Over-the-Counter Drug Regulation

The article was updated April 1, 2020, to reflect that President Trump signed the legislation.

Congress gave final approval March 27 to long-needed legislation that will improve the safety of over-the-counter (OTC) medications.

The bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act passed as part of the sweeping Coronavirus Aid, Relief, and Economic Security Act, which President Donald Trump signed later that day. The OTC bill had support from The Pew Charitable Trusts and a diverse group of medical, public health, industry, and consumer interest organizations.

The measure represents the first significant update to federal oversight for OTC products since 1972. Under the regulatory system established nearly 50 years ago, the Food and Drug Administration (FDA) has not been able to quickly respond to safety concerns or keep pace with innovation.

The act’s provisions would help the agency move with greater speed and agility to protect consumers from unsafe drugs and to permit manufacturers to market new products, steps that would benefit  Americans who use one or more of the roughly 300,000 OTC drugs on store shelves.

Cumbersome system doesn’t put patients first

Unlike prescription drugs, most OTC products are not individually approved by regulators. Instead, FDA publishes, on no set schedule, what is known as a “monograph” for categories of products such as cough and cold treatments, pain relievers, and a wide range of other products including sunscreens and antiperspirants. The monograph describes the active ingredients allowed in a product category, along with acceptable forms (e.g., capsule, liquid, topical cream), dosages or concentrations, and required labeling. If a manufacturer’s product falls within the parameters described in the monograph, it can be marketed without FDA review or approval.

Updating monographs often takes decades under the existing system, a reality that has prevented the introduction of products that would advance patient safety and convenience but don’t comply with outdated monographs. That includes the use of new dosage forms—such as gummies or tablets that dissolve under the tongue—for children or others who have trouble swallowing.

The agency’s complicated system also made it difficult for FDA to protect patients from drugs that were shown to be unsafe or ineffective after approval of the original monograph. For example, in 2016, the agency issued a final rule for consumer antiseptic washes, more than 40 years after beginning the monograph update process and 16 years after researchers began raising safety concerns about active ingredients in some of these products. Until the rule change, the monograph permitted ingredients such as triclosan, an antibacterial agent that is absorbed into the bloodstream more easily than previously thought and that more recent research linked to impaired muscle function.

Meanwhile, no changes have been made since 1987 to the monograph for another category of OTC products—cough and cold medicines—even as serious safety risks have been identified. The current monograph permits labeling that describes these products as appropriate for anyone age 2 or over, despite the fact that these drugs were associated with the deaths of more than 100 children under age 6 between 1969 and 2006. In 2007, an FDA advisory committee recommended against use of these products for this age group, but the original monograph still stands more than a decade later. That means these products can still be legally marketed for children as young as 2, although manufacturers have voluntarily agreed not to label them for children under 4.

New law streamlines system, establishes industry funding

Implementation of the legislation should make it much easier for the FDA to revise monographs to reflect the latest science and respond to safety issues and innovations. Instead of the current multistep rule-making system, the agency would be able to use a faster administrative order process, under which decisions rest with agency scientists—as they do for prescription drug products. The law also gives the agency a mechanism to collect data about OTC drugs in ways that facilitate agency reviews.

Importantly, the measure establishes fees paid by OTC manufacturers to the FDA to ensure regulators have sufficient funding for appropriate oversight. The agency currently allocates fewer than 30 full-time employees with an annual budget of less than $10 million to regulate the entire OTC industry. New resources will allow FDA to expand staff, finalize several monographs that have been pending for years, and consider updates to others that have lagged behind scientific advances.

With the president’s signature, the FDA at last has the authority to create an effective and modern regulatory system for OTC products used regularly by hundreds of millions of consumers.

Liz Richardson directs The Pew Charitable Trusts’ health care products project.