News Releases

Thursday, January 18, 2018

Isakson, Casey Introduce Bipartisan Legislation to Reform Over-the-Counter Drug Regulation

Would protect consumers, encourage innovation

WASHINGTON – U.S. Senator Johnny Isakson, R-Ga., and Bob Casey, D-Pa., introduced bipartisan legislation yesterday that would overhaul the way over-the-counter medications are regulated and brought to market. The reforms aim to protect public health and encourage the development of new products to better meet the needs of patients.

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While modern medicine is constantly improving and adapting as research offers new information, the regulatory system is outdated, putting consumer health at risk and hindering innovation that could benefit all Americans.

The Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315, seeks to streamline and modernize the FDA’s regulatory system to better serve the American public.

“The system for approving over-the-counter drugs and warning consumers about health risks is woefully outdated,” said Isakson. “With this legislation, we have brought everyone to the table and agreed on how we can help consumers, regulators and researchers. I’m eager to see this plan move forward to ensure the health products on Americans’ medicine cabinets and supermarket shelves are effective and accessible for patients, and that innovations can be made well into the future.” 

“The over-the-counter monograph system has not kept up with the needs of the American public or the over-the-counter drug market for years,” said Casey. “This legislation represents a common-sense, bipartisan modernization of the regulation of over-the-counter drugs to provide confidence to American consumers that these drugs have appropriate oversight from the Food and Drug Administration, and that the FDA has the authority to take swift action to protect public health should a safety problem arise. I look forward to working with our colleagues to advance this legislation swiftly.”

Isakson and Casey’s Over-the-Counter Drug Safety, Innovation, and Reform Act could also speed up the current years-long approval process for these medications.

The pharmaceutical industry would help cover much of the costs of the updated regulatory system through “user fees” to support review, new information technology (IT) infrastructure and new full-time employees for the FDA.

Specifically, the legislation 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 a two-year period of product differentiation to reward innovation.
  • Conform to sunscreen regulations to make sure Americans have access to latest protective technology.
  • 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.