The U.S. Food and Drug Administration (FDA) will conduct a public hearing on March 25-26, 2014, in silver spring, Maryland, “to obtain information and comments from the public on the strengths and weaknesses of the current OTC [over-the-counter] Monograph Process, and to obtain and discuss ideas about modifications or alternatives to this process.”Those wishing to attend or provide oral testimony must register by March 12, and comments are requested by May 12.

FDA’s OTC Monograph Process encompasses the agency’s review of nonpre- scription drugs marketed under its OTC drug review procedures, 21 C.F.R. part 330, in effect since 1974. While the 40-year-old process, in FDA’s view, has been successful in maintaining the safety and efficacy of thousands of OTC drug products by therapeutic category, certain challenges remain, including (i) “[t]he large number of products marketed under the OTC Drug Review for which there are not yet final monographs”; (ii) “limitations on FDA’s ability  to require, for example, new warnings or other labeling changes to address emerging safety or effectiveness issues for products marketed under the OTC Drug Review in a timely and effective manner”; and (iii) “the inability of the OTC Drug Review to easily accommodate innovative changes to prod- ucts regulated under the OTC Drug Review.” As part of this initiative, FDA is interested in ideas to change the OTC monograph process “or ideas for its replacement with an entirely new regulatory or statutory framework.”