On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held its first hearing to examine draft legislation to create a new user fee program and completely revamp the review process for OTC drug applications. The bill reforms the existing monograph process – established by FDA in the early 1970s – that relies on notice and comment rulemaking, and replace it with a system that would use administrative orders to authorize drug marketing. Similar to prescription drug and medical device review programs, it pays for the new review process by establishing a user fee program for product applicants and manufacturers” (per Lexology.com, 9-13-2017)
In order to reform the system under which OTC drugs can be marketed in compliance with an OTC Monograph, an OTC user fee solution was recently submitted as part of the OTC Monograph Safety, Innovation, and Reform Act of 2017. Such new regulations would result in changes and opportunities for companies that develop and market OTC drugs in the US.
In a thought provoking presentation, two OTC experts will provide an overview of the OTC market, the opportunity for drug delivery within the Monograph system for OTC drugs, and the path leading forward in capitalizing on the expected changes in the regulatory system. The OTC market worldwide is in excess of $130 billion, and drug delivery has always played a key role in brand extensions and organic growth. The US Monograph system for OTC drugs has been designed to help quickly introduce new technologies for safe and effective product alternatives. Understanding the changing landscape is important in gaining a competitive edge in the future.