Washington, D.C. – Yesterday, the Over-the-Counter Monograph Safety, Innovation, and Reform Act (S.2740), introduced by U.S. Senators Bob Casey (D-PA) and Johnny Isakson (R-GA), passed the full Senate. The Senators introduced this landmark legislation to overhaul the way over-the-counter medications are regulated and brought to market. The legislation seeks to streamline and modernize the U.S. Food and Drug Administration’s (FDA) regulatory system, ensuring effective oversight and speeding up the current years-long approval process for new over-the-counter medications.
“I am pleased that my Senate colleagues have passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act, which will make long overdue updates to the regulation of over-the-counter drugs,” said Casey. “By modernizing regulation of over-the-counter drugs, we will provide confidence to American consumers that non-prescription medications 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.”
“The Over-the-Counter Monograph Safety, Innovation, and Reform Act will help ensure that Americans have effective, accessible health products in their medicine cabinets and on supermarket shelves. In addition, the legislation will ensure innovations can be made well into the future and that we are promoting competition to bring down costs for consumers,” said Isakson. “I thank my Senate colleagues for their overwhelming support in passing this legislation to modernize and overhaul our woefully outdated over-the-counter drug approval process, and I urge our colleagues in the House to quickly follow suit in passing this measure.”
The current system used by the FDA to regulate these medications, called the “over-the-counter (OTC) monograph system,” was implemented in 1972. While modern medicine is constantly improving and adapting as research offers new information, the regulatory system for OTCs is outdated, putting consumer health at risk and hindering innovation that could benefit all Americans. 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.
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 exclusivity 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 six.
- 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.