Washington, D.C. - U.S. Senators Bob Casey (D-PA) and Johnny Isakson (R-GA), today reintroduced legislation to overhaul the way over-the-counter medications are regulated and brought to market.
The current system used by the Food and Drug Administration (FDA) to regulate these medications, called the “over-the-counter monograph system,” was implemented in 1972. While modern medicine is constantly improving and adapting as research offers new information, the regulatory system remains outdated, putting consumer health at risk and hindering innovation that could benefit all Americans.
The Over-the-Counter Monograph Safety, Innovation, and Reform Act, S.2740, seeks to streamline and modernize the FDA’s regulatory system to better serve the American public.
“The over-the-counter monograph system is outdated and has not kept pace with the needs of the American public or the changing drug market for decades,” said Casey. “The Over-the-Counter Monograph Safety, Innovation, and Reform Act would make commonsense updates to modernize the regulation of over-the-counter drugs to provide confidence to American consumers that non-prescription drugs have appropriate oversight from the FDA, and that the FDA has the authority to take swift action to protect public health should a safety problem occur. This legislation has been the product of years of work, and I urge the Senate to take swift action to pass it.”
“It is past time to modernize and overhaul our woefully outdated over-the-counter drug approval process,” said Isakson. “I’m reintroducing the Over-the-Counter Monograph Safety, Innovation, and Reform Act to help ensure that the health products in Americans’ medicine cabinets and on supermarket shelves are effective and accessible for patients, that innovations can be made well into the future, and that we promote competition to bring down costs for consumers.”
Casey and Isakson’s Over-the-Counter Monograph Safety, Innovation, and Reform Act would also speed up the current years-long approval process for new over-the-counter medications.
The pharmaceutical industry would help cover much of the costs of the updated regulatory system through “user fees” to support medication review, new information technology (IT) infrastructure and new full-time employees for the FDA.
This legislation was originally introduced by Casey and Isakson in January 2018 and it was previously approved 22-1 by the Senate Health, Education, Labor and Pensions Committee on April 24, 2018.
Specifically, the Over-the-Counter Monograph Safety, Innovation, and Reform Act would:
- Change the cumbersome monograph rulemaking process to an administrative order process (the same legal authority used for other medical product approvals).
- Allow the secretary of the U.S. Department of Health and Human Services to take rapid action to protect public health in the event of safety issues.
- Establish processes for manufacturers to request administrative orders, or for the secretary to initiate administrative orders at the recommendation of the FDA or in response to citizens’ petitions.
- Establish a process by which drug developers can request meetings with the FDA, similar to existing processes for prescription drug development.
- Create a new incentive to bring innovative over-the-counter products to consumers by providing an 18-month period of product differentiation to reward innovation.
- Require an annual update to Congress on the FDA’s evaluation of the cold and cough monograph with respect to children under the age of 6.
- Authorize the FDA to collect user fees so that the agency has the necessary resources to evaluate and monitor the over-the-counter market.
The full text of the legislation can be found here.