The Pew Charitable Trusts and organizations representing public health advocates, health care providers, and makers of nonprescription drugs and sunscreens praised the reintroduction of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (H.R. 3443) in a June 26 letter to the bill’s sponsors from both parties.
The House bill would streamline the Food and Drug Administration’s regulatory system for over-the-counter products, allowing the agency to act quickly in response to safety concerns or evidence supporting dosage and labeling updates. The bill also would require that makers of these products pay fees to the FDA to ensure that the agency has adequate funds to carry out oversight responsibilities in a timely manner.
In addition to Pew, the letter is signed by the American Academy of Allergy, Asthma & Immunology; American Academy of Pediatrics; American Public Health Association; Consumer Healthcare Products Association; March of Dimes; National Association of County and City Health Officials; Public Access to SunScreens (PASS) Coalition; and the Society for Maternal-Fetal Medicine.
The full letter is included below.
Dear Representatives DeGette, Latta, Dingell, and Guthrie:
We, the undersigned organizations, thank you for your support of public health and for your work on H.R. 3443, the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. As organizations representing public health advocates, health care providers, and manufacturers of nonprescription drugs and sunscreens, we applaud your efforts to modernize the Food and Drug Administration’s (FDA) over-the-counter (OTC) monograph system. As FDA itself acknowledges, the current regulatory system was designed decades ago, and reform is long overdue. Congress must now act to make these reforms a reality.
As demonstrated by the recent finalization of the antiseptic hand wash monograph, 45 years after initial notice of proposed rulemaking, the current framework does not allow FDA to pace with the science in a timely way. This bill would streamline agency oversight, transitioning from the current formal rulemaking process to a more nimble administrative order procedure. Through this change, FDA will be better positioned to take appropriate action in the event of a safety concern and to respond to the latest science with updates in dosage and labeling.
Additionally, the user fees authorized by the bill will provide FDA with needed resources, increasing the agency’s capacity to review OTC ingredient applications, clear the backlog of unfinished monographs, and respond expeditiously if safety concerns emerge. Speeding FDA’s ability to make changes to OTC monographs will encourage product innovation, which will enhance choice and allow patients and consumers to better meet their specific health needs.
Without action on this legislation, FDA will miss out on new resources necessary for timely review and the agency will be forced to continue working under an inefficient regulatory framework that simply cannot keep up with today’s science. A more efficient regulatory structure will enable the agency to better ensure safety and allow manufacturers to bring innovative options to market. Should you have any questions or require additional information, please do not hesitate to contact Sarah Despres at the Pew Charitable Trusts at [email protected] or (202) 540-6601.
American Academy of Allergy, Asthma & Immunology
American Academy of Pediatrics
American Public Health Association
Consumer Healthcare Products Association
March of Dimes
National Association of County and City Health Officials
Public Access to SunScreens (PASS) Coalition
The Pew Charitable Trusts
Society for Maternal-Fetal Medicine
CC: Chairman Frank Pallone, Jr., Ranking Member Greg Walden
America’s Overdose Crisis
Sign up for our five-email course explaining the overdose crisis in America, the state of treatment access, and ways to improve care