August 11, 2020 FDA Provides Playbook for Devel
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Posted On: 08/12/2020 3:10:03 PM
August 11, 2020
FDA Provides Playbook for Developing Cannabis Drugs
The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the Drug Enforcement Administration (DEA) for products that fall under the DEA’s jurisdiction. However, the FDA does provide several useful pieces of information for sponsors and investigators developing drugs derived from cannabis.
Background
This guidance is the direct result of passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill). With its passage, the 2018 Farm Bill removed hemp from the Controlled Substances Act (CSA).
The 2018 Farm Bill defined hemp as: The plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis.
Accordingly, Section 12619 of the 2018 Farm Bill amends the Controlled Substances Act by removing hemp from the definition of marijuana and by de-scheduling components derived from hemp containing a low concentration of THC.
The healthcare industry is interested in the 2018 Farm Bill because the definition of hemp now means that if THC concentrations are less than 0.3 percent on a dry weight basis, the plant Cannabis sativa L. and any part of that plant is not a controlled substance. Historically, all parts of the Cannabis sativa L. plant were classified as Schedule I controlled substances under the CSA. Schedule I means there is no accepted medical use, although research may be conducted under strict controls. Accordingly, after the 2018 Farm Bill, hemp, including hemp plants and cannabidiol preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or conduct research on it.
What does this guidance provide?
This FDA guidance provides clarification on three main issues related to the development of drugs derived from cannabis: sources of cannabis, resources for information on quality considerations and percent delta-9 THC calculation.
First , the FDA reaffirms that the DEA is the lead federal agency for regulating controlled substances. Thus, if a cannabis-derived compound exceeds the threshold of 0.3 percent delta-9 THC by dry weight, sponsors and investigators must comply with the CSA and DEA requirements. Thus, cannabis below the 0.3 percent delta-9 THC threshold may be sourced from anywhere and used for clinical research because this cannabis is not a controlled substance. While cannabis above the 0.3 percent delta-9 THC threshold is a Schedule I controlled substance. Currently, the National Institute on Drug Abuse Drug Supply Program is the only federally legal domestic source of cannabis containing more than 0.3 percent delta-9 THC.
Second , the FDA provides a bibliography of what resources should be consulted to ensure the identity, quality, purity and potency or strength of an investigational drug containing cannabis or cannabis-derived compounds.
Third , the FDA recommends that sponsors and investigators calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain information about the composition of a proposed raw material, intermediate substance, drug substance or drug product. The guidance provides a recommended calculation, for which sponsors should provide documentation when an investigational new drug application is submitted to the FDA. If at any time in the manufacturing process any material, such as intermediates or accumulated byproducts, exceeds the 0.3 percent delta-9 THC by dry weight threshold, sponsors and investigators should consult with the DEA for recommendations on how to handle the material because the material would be considered a Schedule I controlled substance.
Future outlook
This draft guidance provides sponsors and investigators with much-needed insight regarding developing cannabis and cannabis-derived compounds. While this guidance pertains only to drugs, it is anticipate that we may see future guidance or regulation on cannabis and cannabis-derived compounds marketed as dietary supplements.
It is this last sentence (the part underlined) that directly applies to Univec and all other companies involved in research and development of hemp and hemp derived products and treatments. For the first time, research can be done to develop medicinal products and dietary supplements without the fear of prosecution. Bravo, and may I say it is about time.
https://www.jdsupra.com/legalnews/fda-provide...b3ce9f3d94
FDA Provides Playbook for Developing Cannabis Drugs
The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the Drug Enforcement Administration (DEA) for products that fall under the DEA’s jurisdiction. However, the FDA does provide several useful pieces of information for sponsors and investigators developing drugs derived from cannabis.
Background
This guidance is the direct result of passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill). With its passage, the 2018 Farm Bill removed hemp from the Controlled Substances Act (CSA).
The 2018 Farm Bill defined hemp as: The plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis.
Accordingly, Section 12619 of the 2018 Farm Bill amends the Controlled Substances Act by removing hemp from the definition of marijuana and by de-scheduling components derived from hemp containing a low concentration of THC.
The healthcare industry is interested in the 2018 Farm Bill because the definition of hemp now means that if THC concentrations are less than 0.3 percent on a dry weight basis, the plant Cannabis sativa L. and any part of that plant is not a controlled substance. Historically, all parts of the Cannabis sativa L. plant were classified as Schedule I controlled substances under the CSA. Schedule I means there is no accepted medical use, although research may be conducted under strict controls. Accordingly, after the 2018 Farm Bill, hemp, including hemp plants and cannabidiol preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or conduct research on it.
What does this guidance provide?
This FDA guidance provides clarification on three main issues related to the development of drugs derived from cannabis: sources of cannabis, resources for information on quality considerations and percent delta-9 THC calculation.
First , the FDA reaffirms that the DEA is the lead federal agency for regulating controlled substances. Thus, if a cannabis-derived compound exceeds the threshold of 0.3 percent delta-9 THC by dry weight, sponsors and investigators must comply with the CSA and DEA requirements. Thus, cannabis below the 0.3 percent delta-9 THC threshold may be sourced from anywhere and used for clinical research because this cannabis is not a controlled substance. While cannabis above the 0.3 percent delta-9 THC threshold is a Schedule I controlled substance. Currently, the National Institute on Drug Abuse Drug Supply Program is the only federally legal domestic source of cannabis containing more than 0.3 percent delta-9 THC.
Second , the FDA provides a bibliography of what resources should be consulted to ensure the identity, quality, purity and potency or strength of an investigational drug containing cannabis or cannabis-derived compounds.
Third , the FDA recommends that sponsors and investigators calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain information about the composition of a proposed raw material, intermediate substance, drug substance or drug product. The guidance provides a recommended calculation, for which sponsors should provide documentation when an investigational new drug application is submitted to the FDA. If at any time in the manufacturing process any material, such as intermediates or accumulated byproducts, exceeds the 0.3 percent delta-9 THC by dry weight threshold, sponsors and investigators should consult with the DEA for recommendations on how to handle the material because the material would be considered a Schedule I controlled substance.
Future outlook
This draft guidance provides sponsors and investigators with much-needed insight regarding developing cannabis and cannabis-derived compounds. While this guidance pertains only to drugs, it is anticipate that we may see future guidance or regulation on cannabis and cannabis-derived compounds marketed as dietary supplements.
It is this last sentence (the part underlined) that directly applies to Univec and all other companies involved in research and development of hemp and hemp derived products and treatments. For the first time, research can be done to develop medicinal products and dietary supplements without the fear of prosecution. Bravo, and may I say it is about time.
https://www.jdsupra.com/legalnews/fda-provide...b3ce9f3d94
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