WASHINGTON—The Pew Charitable Trusts applauds Congress for passing the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act, which aims to streamline the regulation of over-the-counter (OTC) drugs. The measure was included in the Coronavirus Aid, Relief, and Economic Security Act.
This legislation is the first update to OTC regulations since 1972. The bill’s provisions allow the Food and Drug Administration to more quickly address safety concerns for some existing OTC ingredients and permit manufacturers to more easily market new products.
Liz Richardson, who directs Pew’s health care products project, issued this statement:
“These reforms to FDA’s outdated, inefficient system are long overdue. We thank Congress for its bipartisan efforts to strengthen the agency’s oversight of over-the-counter products to ensure consumer safety and support innovation.
“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.”
Most Americans use one or more of the roughly 300,000 OTC drug products on the market, accounting for $35 billion in annual sales. Unlike prescription drugs, most OTC products are not individually approved; instead, FDA publishes, on no set schedule, a “monograph” for categories of products such as cough and cold treatments, pain relievers, and even sunscreens and antiperspirants. The monograph describes the active ingredients in drugs 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 further review or approval from FDA. Updating these monographs can take decades, a cumbersome process that the Over-the-Counter Monograph Safety, Innovation, and Reform Act will address once the president signs the bill.
Pew has partnered with public health groups, OTC manufacturers, and physicians’ groups in recent months to support the legislation, creating joint principles for reform, sending letters, and providing testimony to Congress. When the legislation is implemented, it will become significantly easier for FDA to update monographs to reflect the latest science, and the law will provide flexibility for the agency to respond to safety issues and innovations. The law also will establish new fees paid by the industry, allowing FDA to expand staff and finalize several monographs that have been pending for years while also removing ineffective or potentially harmful products that may still be on shelves.
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