The global market for botanical and plant-derived drugs expected to grow to $39.6B by 2022 with a compound annual growth rate (CAGR) of 6.1%. The US FDA Botanical Drug Development Guidance for Industry defines a pathway for herbal medicines to become prescription drugs in the US.
The American Botanical Drug Association is an industry trade organization for world wide herbal manufacturers and companies, with a mission to:
Increase public awareness of botanical drugs
Increase options in the healthcare system
Facilitate healthcare policy formation
Serve as a platform for dialogues and collaboration among government agencies, private enteritis, and academics, by means of conferences and meetings
Promote collaboration between the pharmaceutical industry and the botanical and herbal industry
Establish international standards for botanical drugs and its medical usage
ABDA collaborates with research institutes and companies to develop safe and efficacious botanical products to US prescription botanical drugs through FDA botanical drug development pathway.
The pharmaceutical industry has been thriving for many decades but experienced inevitable slowdown in recent years. A new approach for drug development is needed. In 2004, the US FDA issued the "Botanical Drug Development Guidance for Industry". In 2016, FDA published a second edition: if a drug product is derived from single plant or from mix of plants, the Guidance waivers the requirement of:
identifying active ingredients
description of mechanism of action
As long as a botanical product demonstrates safety and efficacy in Phase I, Phase II, and Phase III trials, they are approved as prescription drugs on the US market. This Guidance has open a doors for cannabis-related products and traditional herbal medicines to develop into prescription drugs through US FDA botanical drug development pathway. Two botanical drugs have been approved so far as prescription drugs:
Veregen (sinecatechins), a topical drug for the treatment of genital and perinatal warts.
Fulyzaq (crofelemer), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
By the end of 2018, over 800 IND applications were filed to US FDA under the botanical drug category. The majority of them were allowed to the clinical trial stage. ABDA's mission is to facilitate the development of botanical drug industry.
FDA recommends that researchers interested in developing a cannabis-related drug should refer to the Botanical Drug Development Guidance for Industry and request a Pre-Investigational New Drug application meeting to discuss cannabis-specific issues. In addition, last week’s publication explains that those who are interested in cannabis-related drugs should contact the Center for Drug Evaluation and Research (CDER). Further, the FDA explains how potential researchers can actually get started on cannabis-related drug research by laying out two pre-study processes for cannabis-related drugs: a five-step process for cannabis study drugs containing hemp (with no more than 0.3% THC) and a seven-step process for cannabis study drugs controlled under the Controlled Substances Act (containing more than 0.3% THC). Working with cannabis-related product manufacture to develop botanical drugs is a focus of ABDA.
Internationally, ABDA prompts US FDA botanical drug guidance and collaborates with entities around the globe to develop traditional herbal medicines into botanical drugs in the US. Modern herbal medicines are in forms of pills or capsules. Their safety and efficacy have been demonstrated by daily use on large scale population. Identifying already-known effective herbal medicines with potential indication in the US is an efficient drug development pathway.
Lastly, herbal medicine outside US has utilized little advanced biochemistry research technology. ABDA builds research platform for scientists around the globe to work together to advance technology application in herbal medicine research.