ACI - Legal, Regulatory and Compliance Forum on Over the Counter Drugs

FDA’s NSURE (Nonprescription Safe Use Regulatory Expansion) Initiative which seeks to establish a new paradigm for ‘OTC drugs with conditions of safe use’ will undoubtedly alter existing legal and regulatory protocols and product commercialization in the OTC space. Pharmacist assistance coupled with the use of new technologies and rapid diagnostic testing would in certain instances supplement the current OTC paradigm of self-diagnosis and self-care, thus leading to a multitude of controversies ranging from scope of FDA authority to potential liabilities. Additionally, the granting of OTC status to non-traditional switch candidates such as Oxytrol and the controversy over levonorgestrel also known as Plan B have led to new questions concerning how the NSURE Initiative may also impact the Rx-to- OTC switch mechanism.

To help make sense of the NSURE Initiative and in furthering the objectives of our inaugural OTC conference, ACI’s Second Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs will you help thoroughly comprehend the continuing evolution of the OTC landscape. By attending this event, you will understand how these latest developments will impact the existing legal and regulatory structures which frame the OTC environment.

A distinguished faculty of over two dozen leading legal and regulatory OTC experts — including current and former FDA representatives — will address the intricacies of this new proposal as well as existing challenges affecting such core OTC functions as advertising and promotion; labeling; trademarks, trade names and umbrella branding; and the modernization of the monograph system.

Dick Downing is the Moderator on the topic entitled, "Umbrella Branding for OTCs: Strategies for Maximizing the Value of Trade Names and Trademarks While Avoiding Legal and Regulatory Liabilities."