FDA Workshop: Developing Botanicals as New Drugs

Saturday, August 5, 2006

As a preamble workshop to the 47th Annual Meeting of the American Society of Pharmacognosy in Arlington, VA, the Developing Botanicals as New Drugs workshop was both well-attended and well-received. Below are links to the presentations given at the workshop, as well as contact information for the presenters.

Course Description

The US Food and Drug Administration defines a “botanical” as any product containing ingredients of vegetable matter or its constituents as a finished product. This includes whole plants or plant parts, including plant materials—either juices, gums, fatty oils, scent oils, etc., and also algae or macroscopic fungi and similar products. In the United States botanicalsand other natural products are regulated as foods (including dietary supplements), cosmetics, drugs, biologics and medical devices. When a product is intended to be used to diagnose, treat, prevent, mitigate or cure diseases in humans and animalsAND effects the structure or function of the body, from a legal standpoint it is a “drug.”This Workshop, sponsored by the American Society of Pharmacognosy and the FDA Center for Drug Evaluation and Research (www.fda.gov), explores the rationale behind developing heterogeneous botanical products as drugs, and the scientific and regulatory considerations for product development in the US.

This Workshop was an introduction to the drug development process for naturally heterogeneous products, such as botanicals. Students, academic and industry scientists, researchers, and potential drug sponsors learned from leaders in the field regarding the pertinent US laws, regulations and policy guidances governing the development of botanical drugs.

Specifically the discussion addressed what the FDA is looking for in the Chemistry, Manufacturing, and Controls (CMC) and Pharmacology-Toxicology sections of an Investigational New Drug (IND) application for a botanical drug.

Participants should be able to:

  • Understand the regulatory definition of a “botanical” as defined by FDA.
  • Delineate the different potential ways a botanical product can be marketed in the United States.
  • Identify the differences between “foods” and “drugs,” including how they are defined by “intended use,” and differences in GMPs.
  • Define what a “disease” claim is.
  • Recognize under what circumstances an IND should be filed with the FDA.
  • Understand the IND process, including which form(s) are required, how the FDA reviews botanicals, and on what are the potential agency responses.
  • Delineate the responsibilities of the IND sponsor.
  • Identify what kinds of information will likely be needed for the CMC and Pharm-Tox sections of the IND, and to understand what kinds of additional work may be required for a New Drug Application (NDA).
  • Obtain assistance from the FDA, by understanding how to reach pertinent information, who to contact, and how to utilize the Agency’s website.

Download the workshop PDF:
Workshop: FDA – Developing Botanicals as New Drugs