FDA Plans to Overhaul Regulation of OTC Medications

MARCH 11, 2014
The FDA announced plans to hold a meeting on March 25 and 26, 2014, to discuss potential changes to regulation of OTC medications. The current system, known as the over-the-counter monograph, has been in place since 1972 and involves multiple rounds of scientific review, public hearings, and comments before a final “monograph” is published. As a result, many OTC products remain technically under review for years and it is very difficult to add warning labels regarding newly recognized safety risks in a timely manner.

Drug manufacturers are also limited in their ability to make changes to their products’ dosing, formulation, and labeling, which all must go through the monograph process. For example, manufacturers of children’s medications containing acetaminophen have been trying for years to add information on dosing for children younger than 2 years. Despite a unanimous recommendation by an FDA expert panel in 2011 that this information be added, it is still working its way through the monograph process.

In announcing the meeting, the FDA said that it aims to design a system that will “allow for innovative changes to drug products [and] provide FDA with the ability to respond promptly to emerging safety or effectiveness concerns.”


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