OTC Monograph System Gets an Update

This month’s Ask the Expert is answered by EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane. Susan specializes in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution of OTC drugs and dietary supplements.

Each month EAS chooses one question sent in by a reader of EAS-e-News. To submit your question, use the Contact Us link on our website.

Q: Why is FDA updating the OTC monograph system?

Crane: The current OTC monograph system has been in use since the 1970’s and has proven to be a lengthy and cumbersome rule-making process for finalizing, or making changes to the monographs. Several monographs have been in the “Tentative Final” stage for 40 years, while hundreds of active ingredients still lack FDA determination as to their safety and effectiveness. The FDA simply lacks the resources to manage the system as it currently exists.

To address the problem, the FDA, in consultation with other stakeholders, worked with Congress to draft legislation. The resulting Over-the-Counter Drug Safety, Innovation, and Reform Act is currently moving through the legislative process with bipartisan support so is expected to pass and be signed into law, hopefully before the mid-term elections in November.

The reforms include, but are not limited to:

  • replacing the current rule-making process with a more efficient “administrative order” process
  • providing FDA with funding through a new user fee program
  • providing mechanisms to allow FDA to more quickly address safety issues that arise
  • encouraging innovation by offering exclusivity to manufacturers for new active ingredients or conditions for use

EAS is monitoring the legislation and will provide details as they become available.

Posted in 2018 July, Ask the Expert.