ACI - The Legal, Regulatory & Compliance Forum on OTC Drugs

FDA's proposed introduction of a new paradigm for 'OTC drugs with conditions of safe use' (which some industry observers have referred to as a third class of drug product or 'behind the counter'/ 'BTC' products ) will put a new twist on existing legal and regulatory protocols and product commercialization in the OTC space.  Self-diagnosis and self-care, two basic tenants of the current OTC paradigm may be supplemented with the assistance of a pharmacist and rapid diagnosis testing, thus leading to a multitude of questions ranging from scope of FDA authority to potential liabilities.

To help make sense of this new proposal and its potential impact on existing legal and regulatory structures in the OTC environment, ACI has developed The Legal, Regulatory and Compliance Forum on Over the Counter Drugs.   A distinguished faculty of over two dozen leading legal and regulatory OTC experts --- including 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 line extensions; and the modernization of the monograph system.

Dick Downing is scheduled to speak on October 18th on the topic of "Making and Maintaining Your Mark:  Mitigating Legal and Regulatory Risks Relative to Trademarks, Trade Names and Brand Name Product Line Extensions in the OTC Space."