The Food and Drug Administration has issued a warning about the use of over-the counter (OTC) teething products that contain benzocaine, a common topical pain reliever, but the agency has limited ability to act because these products for infants and toddlers are regulated under FDA’s outdated OTC monograph system.
That means the only immediate action the agency can take is to strongly advise parents and physicians against using these items and ask companies to voluntarily remove them from store shelves. Lawmakers in both the U.S. House of Representatives and the Senate have introduced bipartisan legislation to reform the monograph system. FDA’s May 23 warning about benzocaine is the latest reminder of why reform cannot wait.
Currently, OTC drug products can go on the market without FDA preapproval if they adhere to the monograph for their active ingredients. The monograph provides important details, such as the form the product may take (e.g., oral liquid, tablet, topical ointment) and what indications and dosing information can appear on the label. But the process for changing that guidance is cumbersome, even when quick action is warranted.
When safety issues arise that require monograph changes, FDA must engage in notice and comment rule-making, which can take decades. Last year, the banning of certain ingredients in antibacterial soaps made headlines, but that decision was more than 20 years in the making—because of the inefficient system under which FDA operates. And that process ended only because of a court order.
In other instances, necessary monograph changes are long-pending, and some of these, such as for teething products, primarily affect children. For example, the monographs for cough and cold and acetaminophen products need to be changed to modify labels to reflect the risks of use by young children or to provide more accurate dosing for babies and toddlers.
Over the past year and half, The Pew Charitable Trusts has been working with a variety of stakeholders, including industry, the American Academy of Pediatrics, and other public health groups, to advance legislation that would reform the monograph system and grant FDA the authority and resources to respond to safety issues in timely and decisive ways. Pew developed a set of joint principles with several of these groups that are reflected in the bills in the House (H.R. 5333, which was introduced in March), and the Senate (S. 2315, introduced in January). Both have made it out of committee and leadership should bring them to the floor for a vote.
In the case of benzocaine, FDA pursued voluntary industry action instead of changing its regulations because, the agency said, “lengthy notice and comment rulemaking procedures” were “generally not well-suited to either addressing safety concerns that arise before a monograph is finalized or keeping pace with evolving science.”
FDA described pending OTC-reform legislation as a “transformative shift” that would allow it to address safety concerns. The next time the agency identifies a concern with an OTC product, it should be able to move quickly to protect public health without navigating needless bureaucracy. It’s time to get this legislation done and empower FDA to carry out its mission of protecting patients and consumers from harmful products.
Elizabeth Jungman directs The Pew Charitable Trusts’ public health programs.