Cannabinoid Evaluation and FDA Approval

Cannabinoid

Evaluation and

FDA Approval

Only certain cannabinoid products have undergone or are undergoing a federal testing and approval process.

The rigorous FDA-approval process is undertaken in an effort to establish the efficacy, safety, and quality of a medicine before use by the general public.1 FDA-approved medicines are available by prescription in both specialty and/or retail pharmacies, not dispensaries.

Cannabinoid products that have not undergone the FDA-approval process are sold in dispensaries and online.2,3 These should not be considered substitutes or generics for FDA-approved medicines.

Approval Process

References: 1. What we do. US Food & Drug Administration website. https://www.fda.gov/AboutFDA/WhatWeDo/. Accessed January 23, 2018. 2. Bonn-Miller MO, Loflin MJE, Thomas BF, Marcu JP, Hyke T, Vandrey R. Labeling accuracy of cannabidiol extracts sold online. JAMA. 318(17):1708-1709.

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3. Warning letters and test results for cannabidiol-related products. US Food & Drug Administration website. https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm. Accessed January 23, 2018. 4. Borchardt D. The cannabis market that could grow 700% by 2020. Forbes. December 12, 2016. 5. Step 3: clinical research. US Food & Drug Administration website. https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm. Accessed January 23, 2018. 6. Marinol [package insert]. North Chicago, IL: AbbVie Inc; 2017. 7. Cesamet [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc; 2013. 8. Syndros [package insert]. Chandler, AZ: Insys Therapeutics, Inc; 2017.

References: 1. Marinol [package insert]. North Chicago, IL: AbbVie Inc; 2017. 2. Cesamet [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc; 2013.

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3. Syndros [package insert]. Chandler, AZ: Insys Therapeutics, Inc; 2017. 4. Drug Schedules. US Drug Enforcement Administration website. https://www.dea.gov/druginfo/ds.shtml. Accessed January 22, 2018. 5. European Monitoring Centre for Drug and Drug Addiction (EMCDDA). European drug report 2016: trends and developments. http://www.emcdda.europa.eu/system/files/publications/2637/TDAT16001ENN.pdf. Accessed January 22, 2018.

FDA-Approved versus Non–FDA Approved Cannabinoid Products
Study and Evidence Requirements

FDA-Approved Cannabinoid Products1.2
Studied in placebo-controlled publicly disclosed clinical trials with large patient samples to determine efficacy, safety, and recommended dosing.

Non–FDA-Approved Cannabinoid Products3
Randomized clinical studies have not been conducted. Public disclosure of smaller, informal studies not required.

Manufacturing

FDA-Approved Cannabinoid Products1.2
Produced according to regulated, current good manufacturing practices (cGMP). FDA-approved medications must adhere to strict specifications that ensure batch consistency and stable shelf life.

Non–FDA-Approved Cannabinoid Products3
Testing standards vary from state to state, and some states require no testing. There are no federal standards; FDA does not inspect the manufacturing sites for adherence to cGMP.

Quality Standards

FDA-Approved Cannabinoid Products1.2
Meets FDA standards for quality, stability, consistency. Tested to ensure they contain the consistent concentrations of cannabinoids and other product ingredients listed on the label.

Non–FDA-Approved Cannabinoid Products3
Non-prescription, non-FDA-approved cannabinoid products are subject to inconsistent regulation at the state level. There are no federal standards for testing to ensure accuracy and consistency.4

Legality

FDA-Approved Cannabinoid Products1.2
Federally legal as prescribed: similar to other DEA-controlled prescription medicines.

Non–FDA-Approved Cannabinoid Products3
Restrictions to access vary by state.5 Healthcare providers can "recommend" but not prescribe hemp products or marijuana, as they are illegal at the federal level. Interstate transportation of these products is federally illegal.

Coverage

FDA-Approved Cannabinoid Products1.2
Eligible for insurance coverage

Non–FDA-Approved Cannabinoid Products3
Insurance coverage is rare

How the FDA-Approval Process Helps Healthcare Providers and Consumers

Download and share this valuable guide to understanding
the FDA approval process.

References: 1. The FDA’s drug review process: ensuring drugs are safe and effective. US Food & Drug Administration website. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm. Accessed October 31, 2017. 2. Guidance for industry, Q7 good manufacturing practice guidance for active pharmaceutical ingredients. US Food & Drug Administration website. https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm200364.htm. Accessed October 30, 2017.

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3. Guidelines for the use of non-pharmaceutical grade compounds in laboratory animals. National Institutes of Health website. https://oacu.oir.nih.gov/sites/default/files/uploads/arac-guidelines/pharmaceutical_compounds.pdf. Accessed October 30, 2017. 4. Warning letters and test results for cannabidiol-related products. US Food & Drug Administration website. https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm. Accessed January 23, 2018. 5. State medical marijuana laws. National Conference of State Legislatures website. http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx. Accessed October 31, 2017.

There currently are FDA-approved cannabinoid medicines for:

*Check all that apply

Approved Medicines

References: 1. Marinol [package insert]. North Chicago, IL: AbbVie Inc; 2017. 2. Syndros [package insert]. Chandler, AZ: Insys Therapeutics, Inc; 2017.

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3. Cesamet [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc; 2013. 4. Sativex [package insert]. Berkshire, United Kingdom: GW Pharma Ltd; 2015. Quiz 2 1. The FDA’s drug review process: ensuring drugs are safe and effective. US Food & Drug Administration website. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm. Accessed October 31, 2017. 2. Guidance for industry, Q7 good manufacturing practice guidance for active pharmaceutical ingredients. US Food & Drug Administration website. https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm200364.htm. Accessed October 30, 2017. 5. Guidelines for the use of non-pharmaceutical grade compounds in laboratory animals. National Institutes of Health website. https://oacu.oir.nih.gov/sites/default/files/uploads/arac-guidelines/pharmaceutical_compounds.pdf. Accessed October 30, 2017.

Additional testing for CNS medicines

For medicines that work through the central nervous system (CNS), developers are required to conduct studies to assess abuse potential and liability. These studies determine if a medicine could make a patient physically dependent and have the potential to be abused or misused.1

When do drugs get expedited review?

For drugs that address an unmet medical need in the treatment of a serious or life-threatening condition, the FDA offers expedited programs to help ensure that therapies are reviewed and made available to patients earlier when they have promise in treating such conditions.2

While medicines are being developed, can they be accessed by people not in clinical studies?

In some cases involving serious diseases or conditions, the FDA provides a pathway for physicians to request access to drugs for their patients while the drugs are being studied, before they are approved.3 This is referred to as expanded access or compassionate use.

References: 1. Assessment of abuse potential of drugs: guidance for industry. US Food & Drug Administration website. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm198650.pdf. Accessed January 23, 2018. 2. Guidance for Industry: expedited programs for serious conditions—drugs and biologics. US Food & Drug Administration website. https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf. Accessed January 23, 2018.

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3. Expanded access: information for patients. US Food & Drug Administration Web site. https://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm. Accessed January 23, 2018.

True or False?

All cannabinoid products are tested to ensure they contain the consistent concentrations of cannabinoids and other product ingredients listed on the label.

References: 1. The FDA’s drug review process: ensuring drugs are safe and effective. US Food & Drug Administration website. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm. Accessed October 31, 2017. 2. Guidance for industry, Q7 good manufacturing practice guidance for active pharmaceutical ingredients. US Food & Drug Administration website. https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm200364.htm. Accessed October 30, 2017.

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3. Guidelines for the use of non-pharmaceutical grade compounds in laboratory animals. National Institutes of Health website. https://oacu.oir.nih.gov/sites/default/files/uploads/arac-guidelines/pharmaceutical_compounds.pdf. Accessed October 30, 2017.