Freddie Ann Hoffman
Heterogeneity LLC, USA
Title: Regulatory considerations of botanicals as new drugs for the US market
Biography: Freddie Ann Hoffman
Medicinal use of plant-based products has its origins in antiquity estimated to date back at least 60,000 years. Today approximately 80% of the world’s population continues to utilize plants and plant products to treat or prevent clinical conditions. In the United States, plant-based medicines were a major part of pharmaceutical armamentarium that is up until the passage of the US Drug amendments of 1962. The drug amendments further established requirements for new drug approval in the US, specifically requiring that the US Food and Drug Administration must affirm the safety and efficacy of a new drug prior to market approval. It was not until FDA’s dissemination of its Botanical Drug Development Guidance document, several decades later, that the US development of botanicals as drugs has experienced resurgence. At present there are two FDAapproved new botanical drugs that are sold exclusively by prescription in the US. This session will discuss how the FDA defines a botanical and the implications of the US regulatory approach on the development and approval of this renewed drug category, along with some of the lingering hurdles to this special category of new drugs.