Forty-five years after the Food and Drug Administration (FDA) started to update the agency-approved recipe—called a monograph—for over-the-counter hand sanitizers, it announced in April that it had finished the task. The fact that it took more than four decades illustrates why FDA, along with medical, public health, industry, and consumer interest groups, are calling for legislative reform of the monograph system.
Most Americans routinely use over-the-counter (OTC) drugs. Unlike prescription drugs, OTC products typically are not individually approved, but are instead regulated through a system whereby FDA publishes a monograph for whole categories of products, such as pain relievers, sunscreens, or antiperspirants. The monograph describes active ingredients that can be used in products in each category, along with acceptable forms (such as capsule, liquid, or 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 additional FDA review or approval.
The process for updating monographs, however, is cumbersome. FDA and the Department of Health and Human Services review proposed changes, while the White House Office of Management and Budget often estimates the cost and benefit of any changes to the economy and consumers. In addition, FDA must solicit, and respond to, public comment throughout the revision process. Altogether, these efforts can—and often do—take decades to complete. By contrast, new drug applications are reviewed solely by FDA to determine whether the product is safe and effective. Approvals can be completed in as little as six months.
In the hand sanitizer example, FDA first published an advance notice of proposed rule-making—the first step toward updating a monograph—in 1974. But in the succeeding years, as consumers dramatically increased their use of these products, new information about the safety of some active ingredients emerged. For example, scientists discovered in 2000 that an often-used antibacterial substance called triclosan was absorbed into the bloodstream more easily than previously thought, and then found in 2012 that it could impair muscle function.
Over many years, FDA continued taking steps toward updating the monograph, and in 2016, published a final rule limited to “consumer antiseptic washes” that determined that triclosan and 18 other chemicals were unsafe. In April, it published the final monograph for the broader category of all OTC topical antimicrobial products.
In another concerning example, the monograph for cough and cold products, finalized in 1987, permits their use in children 2 and older despite these products being linked to the deaths of more than 100 children younger than 6 between 1969 and 2006. More than 10 years ago in 2007, an FDA advisory committee recommended that these products should not be used for this age group, but the original monograph still stands. 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.
The lengthy and complex monograph update process has also stifled innovation in the marketplace by preventing the introduction of products that could benefit consumers but don’t adhere to existing monographs. That includes new dosage forms, such as gummies or tablets that dissolve under the tongue for children or others who have trouble swallowing pills.
The problems with the current monograph system will become more severe over time, according to Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, the division responsible for evaluating prescription and OTC drugs before they can be sold.
“Without the passage of monograph reform legislation, the shortcomings of the existing, out-of-date monograph system will continue and worsen,” she told Pew last year. “Challenges in accommodating innovation and keeping pace with evolving science will remain.”
Along with medical, public health, industry, and consumer interest groups, Pew supports the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act, which would modernize the system by eliminating the burdensome rule-making process for changing monographs, and expand FDA funding through new user fees paid by manufacturers of OTC products. If FDA identifies a safety issue in an over-the-counter product today, it should not take 45 years—until 2063—for its monograph to address that concern.
Liz Richardson directs The Pew Charitable Trusts’ health care products project.