FDA Requests Input Regarding Re-engineering of the 40 Year Old OTC Monograph Process

By Riëtte van Laack –

The Over-the-Counter (“OTC”) drug regulatory framework was established by FDA more than 40 years ago in the OTC Drug Review.  The procedure was intended to lead to a monograph which described the active ingredients and conditions that are generally recognized as safe and effective (“GRASE”) for each of more than 60  categories of OTC drugs.  The rulemaking procedure for evaluating each category of OTC drug products involved a three part rulemaking process, including an Advanced Notice of Proposed Rulemaking (representing the recommendations of an independent advisory review panel), a Tentative Final Monograph (“TFM,” or proposed rule) and a Final Monograph (or final rule).  If an OTC drug meets the requirements detailed in a final monograph, it is GRASE and does not require approval of a new drug application or any other individual review by FDA.

In a February 24, 2014 Federal Register notice, FDA announced its opinion that the OTC Drug Review needs critical examination.  The agency indicates that it has determined that the OTC monograph system is not efficient, does not allow for rapid product innovation, and is not designed to respond quickly to newly emerging information. 

FDA identifies a number of challenges of the current system.  For example:

• A large number of products is currently marketed under TFMs (FDA claims there are more than 150 TFMs).  Under FDA’s enforcement policy, OTC drug products that were on the market at the time the review began may remain on the market pending finalization of the monograph.  This includes products for which FDA has insufficient data to determine safety and effectiveness.
• Changes to a final monograph require notice and comment rulemaking, thus limiting FDA’s ability to respond promptly to emerging safety data.  
• With some exceptions, the OTC review is limited to active ingredients in specific dosage forms that were available at the inception of the review.  Thus, this system does not easily accommodate innovative changes to OTC drug products, e.g., new combinations or new dosage forms of active ingredients.

FDA invites comments on the strengths and weaknesses of the existing OTC Drug Review and on some preliminary concepts for modernizing the process.  The agency also invites suggestions on how to develop a system that (ideally) will:

• use modern standards for safety and efficacy;
• provide an efficient and speedy mechanism for finalizing the remaining TFMs;
• allow for innovative changes to drug products;
• provide FDA with the ability to respond promptly to emerging safety or effectiveness concerns for monograph products;
• allow FDA to address pediatric use and labeling where appropriate; and
• allow FDA to obtain information about the final formulation of individual OTC drug products or establish testing standards for the final formulation.

Comments need not address all challenges of the current system.

The public hearing is scheduled for March 27 and 28, 2014.  Written comments, however, may be submitted until May 12, 2014.