New Reforms for Over-the-Counter Drugs

In a move designed to streamline regulation of over-the-counter drugs, Congress passed—and President Donald Trump signed—legislation in March that will allow the Food and Drug Administration to move more quickly to address safety concerns and permit manufacturers to more easily market new products.

A coalition of medical organizations, drug manufacturers, and consumer groups, including The Pew Charitable Trusts, had sought the reforms that were the centerpiece of the Over-the-Counter Monograph Safety, Innovation, and Reform Act. The law, which received bipartisan support, was included in the massive coronavirus relief legislation approved by lawmakers and marks the first significant regulatory changes for over-the-counter medications since 1972.

“This bill improves public health protections and sets us on a path to a modern, streamlined system for regulating drugs that hundreds of millions of Americans use every year,” says Liz Richardson, who directs Pew’s health care products project.

Pew staff compiled evidence, testified before Congress, and helped create a coalition of public health and provider organizations that built enough support among lawmakers and stakeholder groups to push the package to enactment.

Over-the-counter drugs play a central role in many Americans’ lives. Studies show that 4 in 5 adults use the medications as a first response to minor ailments, and there are more than 300,000 of these drugs on the market, with annual sales of $35 billion.

Some of these drugs, such as allergy medicines and antacids, are regulated like prescription medications: FDA reviews clinical data and other materials submitted by the drug manufacturers and then determines whether the products are safe and effective enough for sale.

But the great majority of over-the-counter drugs are regulated differently, through an FDA-administered process known as the monograph system; the monographs cover product categories such as cold and cough treatments, pain relievers, and antiperspirants. A monograph describes the active ingredients allowed in a product category; the acceptable forms for the drug, such as capsule, liquid, or topical cream; the 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.

Sometimes, however, new research suggests the ingredients in a monograph are less safe than previously thought. In those cases, under the old law, FDA had to go through a complex notice-and-comment rule-making process to make changes. The process typically took many years, sometimes decades.

For example, FDA updated rules for hand sanitizer in 2016, more than 40 years after beginning the monograph update process. That was 16 years after researchers began raising safety concerns about active ingredients in some of these products. Until the changes, the monograph permitted ingredients such as triclosan, an antibacterial agent that has been linked to impaired muscle function and is absorbed into the bloodstream more easily than previously thought.

Another example of lengthy delay involves cough and cold medicines for which no monograph changes have been made since 1987, even as serious safety risks have been identified. The current monograph permits labeling that says the products are appropriate for anyone age 2 or over, even though 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. It 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.

In short, the system “was in desperate need of modernization,” according to Scott Melville, president and CEO of Consumer Healthcare Products Association, which was part of the coalition seeking the reforms.

There were many reasons for these inefficiencies, starting with FDA’s limited resources. Before passage of the new law, the agency had fewer than 30 full-time employees working on the monograph process, with an annual budget of less than $10 million. Mandates from Congress and the courts focused most of these resources on specific products, including sunscreens and antibacterial soaps.

In addition, obtaining and distilling information on over-the-counter products was a hodgepodge process for regulators. Unlike information about prescription drugs and medical devices, data on over-the-counter products was not submitted in standardized formats. FDA reviewers typically had to sift through years of often outdated and unorganized material and then try to reshape it in a format allowing useful reviews. The agency had no authority to require specific data from manufacturers, so the drugmakers weren’t obligated to submit negative evidence.

This required FDA staffers to search scientific literature or to commission research to resolve any data gaps before changing a monograph’s status. Still other steps for a proposed change to over-the-counter products included obtaining projected cost implications from the White House Office of Management and Budget.

“It was a complex process,” Richardson says. “When combined with the FDA’s limited resources and restricted authority to seek adequate data from manufacturers, it was really hard for the agency to analyze the evidence, act on safety concerns, and accommodate innovation.”

By contrast, FDA could review and approve a new prescription drug application in less than a year.

The new law will make it much easier for FDA to respond to safety issues and innovation and to more quickly update monographs to reflect the latest science, with decision-making resting with agency scientists as it does with prescription drugs. The law also establishes fees, to be paid by the drug industry, that will enable FDA to expand staff, finalize long-pending monographs, and remove ineffective or potentially harmful products from stores.

The coalition that prompted the reforms included a range of medical groups such as the American Academy of Pediatrics, whose CEO, Mark Del Monte, calls the legislation “an important victory for children’s health.”

 “Pediatric labeling on older drugs is based on evidence that no longer meets current safety and efficacy standards or on incorrect assumptions about how adult data should inform the labeling of drugs for children,” he says.

The new law, he says, will make it easier for FDA “to keep up with the latest scientific developments and address safety concerns.”

Charles Babington is a Washington journalist and frequent contributor to Trust.