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 and cannabis derived products to become prescription drugs in the US.
The American Botanical Drug Association (ABDA) is an industry organization 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 entities, 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 prescription botanical drugs through FDA botanical drug development pathway.
The pharmaceutical industry has been thriving for many decades but experienced slowdown in recent years. New drug development methods are needed. The US FDA ”Botanical Drug Development Guidance for Industry" opens doors for botanical products like herbal medicines or cannabis derived products to develop to prescription drugs: if a drug product is a single plant or from a mix of plants, the Guidance waives the requirement of: 1) identifying active ingredients, 2) description of mechanism of action. As long as botanical products demonstrate safety and efficacy in phase 1, phase 2, and phase 3 trials, they are approved as prescription medication on the US market. Between 2016 to 2019, 195 botanical drug clinical trials were registered, of which 81 are phase 2. By the end of 2018, over 600 IND applications were in clinical development under the botanical drug category. Two botanical products have been approved as prescription drugs:
Veregen (sinecatechins), a topical drug for the treatment of genital and perinatal warts.
Mytesi® (crofelemer) (old name Fulyzaq), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
ABDA's mission is to facilitate the development of the botanical drug industry.
Modern herbal medicines are in forms of pills or capsules. Their safety and efficacy have been demonstrated by daily use on a large population. Identifying already-known effective herbal medicines with promising is an efficient drug development pathway. ABDA promotes US FDA botanical drug guidance and collaborates with entities around the globe to develop herbal medicines to US prescription botanical drugs.
FDA issued a draft Cannabis Product Guidance for Industry to encourage cannabis derived products to be developed into prescription drugs through FDA botanical drug pathway.
ABDA develops research platforms for scientists around the globe to work together to advance technology application in herbal medicine research.
By working with research institutions and entities around the world, ABDA develops and publishes industry standards.