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Regulatory and Policy Research Note
OTC Drug Monograph Modernization Project Announced By
FDA, Joining Previous Effort to Broaden OTC Category
The Food & Drug Administration's announcement that it wants to begin collecting public comments and suggestions for updating the 40-year-old OTC Drug Monograph process further identifies that sector of FDA regulation as an area in pre-flux – with a lot of study and discussion but probably a long way to go to big changes. FDA is keen to make substantial procedural changes in the OTC area but is putting so much current policy under review that it appears instead to be spinning its wheels. of a Part 15 public meeting to revisit the OTC Monograph regulatory structure was previewed on Friday, February 21. The hearing dates are March 25-26 at FDA's White Oak The newly announced project has a broad agenda: from finding shorter routes for FDA to
finish the Final Monograph process to handling new safety issues for OTC ingredients and
dosages in Final Monographs or de facto protected in Tentative Final Monographs; to finding
easier ways to update monographs.
By coincidence, the recent announcement is almost three years exactly from the announcement of a similar Part 15 hearing on redefining and broadening the range of products that could be made available OTC by using new technologies to extend the "conditions of safe use." (See our March 23, 2012 note, That previous effort to overhaul the definition of drugs suitable for OTC led to a project called "Nsure" (Nonprescription Drug Safe Use Regulatory Expansion), to a lively two-day public hearing in March 2012, to follow-up meetings under the aegis of the Brookings Engelberg Center, but not to any major regulation revision effort. However, the discussion of the Nsure concept does appear to have had some indirect benefits in making FDA more receptive to discussions of consumer education on programs as part of OTC NDAs such as Merck's for Oxytrol for over-active bladder in women. (See our January 25, 2013 note, FDA Encourages Big Ideas on Monograph Change, Further Defining A Long Process
FDA says ideas for reforming the monograph system do not have to build off the existing regulatory platform. The agency is "interested in hearing the full range of ideas, including novel ideas for new regulatory frameworks." That type of broad request for new systems to potentially replace the monographs as well as refinements to make the old system more "agile" defines a task that FDA recognizes it is not likely PHONE (202) 747-9476 1055 Thomas Jefferson St. NW Washington, DC 20007 WEBSITE HTTP://PREVISIONPOLICY.com
Regulatory and Policy Research Note
to accomplish quickly. Paired with the still pending effort to examine and incorporate new forms of providing patient information to make more drugs available OTC, FDA has carved out a big task. It is an important task and FDA's unveiling of the effort at this point could cause some distractions to rumored efforts by companies to get rid of OTC businesses. The initiation of a regulatory overhaul process – even a long-term one – could cause some review of the value of OTC franchises. FDA does identify the skeleton of an ideal solution to its objectives for updating the monograph system. The agency describes an "ideal, comprehensive solution" as including:  Modern standards for safety and efficacy;  An efficient mechanism for finalizing the status of drug products that are currently marketed under TFMs (tentative final monographs);  A way to allow for innovative changes to drug products;  A method for FDA to respond promptly to emerging safety or effectiveness concerns;  A way for FDA to easily and quickly require additional information or data nece3sssary to develop pediatric labeling where appropriate;  A system to obtain final formulation information about individual products or readily establish final formulation testing standards. FDA exhibits a particular interest in one currently under-used process for getting new versions of final monograph ingredients to the market: the NDA deviation process (Sec 330.11). The agency describes it in terms that make it appear as a route to a proto-ANDA system. The process as it exists is a form of abbreviated, but limited, application that can rely on certain data submitted to an OTC monograph to be supplemented by data relating to the "deviation" from the monograph ingredient. That process is estimated to take about three to five years but does offer the potential for three-year exclusivity for a product that goes that route. FDA notes that "industry has not utilized the NDA deviation process as a pathway to marketing very often." FDA is curious why. "The agency is interested in learning why this is and whether there are changes that could be made to the existing NDA deviation process that would make it a more attractive alternative for industry and that could allow marketing of additional drug products without having to submit a full NDA." FDA is not seeking to limit the March 25-26 conversation but it does ask for comments on strengths and weaknesses of the current system; concepts for modernization; and suggestions for alternatives or modifications (See list below). FDA List of Topics For March 25-26 OTC Monograph Review Meeting
A. Strengths and Weaknesses of the Existing OTC Drug Review  What aspects of the OTC Drug Review continue to function effectively?  Which aspects of the OTC Drug Review are most in need of change? PHONE (202) 747-9476 1055 Thomas Jefferson St. NW Washington, DC 20007 WEBSITE HTTP://PREVISIONPOLICY.com
Regulatory and Policy Research Note
 Are there additional mechanisms to eligibility for the OTC Drug Review that could be explored? If so, what should be the parameters of eligibility?  Why is the NDA deviation process rarely used by industry? Are there changes to that process that would make it a more appealing and appropriate alternative pathway? B. Preliminary Concepts for Modernization Described in This Document  Ideas for a streamlined process that would allow us to promptly resolve all TFMs.  Issue monographs by administrative order.  Issue regulations to require product specific information and expand the use of guidances.  Expand the NDA deviation process. C. Your Suggestions for Modifications or Alternatives to the OTC Drug Review  What alternatives or changes to the OTC Drug Review would modernize or improve FDA's regulation of monograph drugs?  What changes can facilitate speedier finalization of the remaining monographs?  How can the Agency most expeditiously address emerging safety issues for drugs regulated under the OTC  Are there specific changes to the OTC Drug Review that the Agency could employ to address the lack of pediatric data for some final monographs?  Should the only alternative to marketing an OTC drug under an OTC monograph be an NDA or abbreviated NDA approval? If not, what could another alternative be?  Are there other regulatory mechanisms (not necessarily used for the regulation of drug products) that are used by other agencies in the United States or in other countries that FDA could consider using to regulate OTC drugs products? PHONE (202) 747-9476 1055 Thomas Jefferson St. NW Washington, DC 20007 WEBSITE HTTP://PREVISIONPOLICY.com

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