State Rescheduling for a Pathway for FDA
Approved Therapies Derived from CBD
Frequently Asked Questions
The Epilepsy Foundation is bringing together the epilepsy community to advocate for changes to state
scheduling laws that would allow therapies derived from cannabidiol (CBD) and approved by the Food
and Drug Administration (FDA) to become available to patients timely manner.
Therapies derived from cannabidiol (CBD) show promise for people living with uncontrolled seizures
and rare epilepsies. Even with FDA approval, states would need to implement changes to state
scheduling laws for these therapies to become available in the state, even if the state has a medical
cannabis program.
What does it mean to be an FDA approved therapy derived from CBD?
The FDA examines potential therapies for safety and efficacy, and approves a therapy when the benefits
of said therapy outweigh the potential risks for a specific condition(s), also known as indication(s).
Products made with CBD are considered to be derived from CBD. Not all products made from CBD go
through the FDA approval process, which includes multiple studies to determine a product’s safety and
efficacy for treating a particular medical condition. If a product derived from CBD successfully goes
through the FDA approval process, it would be considered an FDA approved therapy. For many
epilepsy medications, including those derived from CBD, there is an additional step, DEA scheduling,
before the medication can be available to patients.
If FDA approves and DEA schedules a therapy derived from CDB, why do the states need to take
action?
After FDA approval, the Drug Enforcement Agency (DEA) will reschedule the FDA approved therapy
derived from CBD. In addition, to the federal action by DEA, individual states would them be
responsible for rescheduling the therapy because it is derived from a Schedule I substance. If action is
not taken in a state, the FDA-approved therapy would not be available in that particular state.
If a state has a medical cannabis program or related legislation, why is state rescheduling
legislation or regulatory action needed?
Most state medical cannabis programs were created by laws that did not reschedule cannabis or CBD.
These laws often define cannabis and/or CBD, and outline criteria for the medical conditions for which
medical cannabis is allowed under state law. Even in the few states that rescheduled cannabis or CBD,
the change was to a Schedule II, which is still very restrictive and would not allow for timely and
meaningful access to FDA approved therapies derived from CBD.
What action(s) does my state need to take in order for FDA approved therapies dervived from
CBD to be available?
Each individual state has its own laws on which governing body is responsible for rescheduling changes
to ensure a therapy is available in the state after FDA approval and DEA scheduling. In many states, it
State Rescheduling for a Pathway for FDA
Approved Therapies Derived from CBD
Frequently Asked Questions
is the state legislature that is responsible for rescheduling a drug, while in others it is a state agency such
as the Board of Pharmacy or Department of Health.
What will happen if my state does not act or does not act in timely manner?
If a state does not take action, people living with epilepsy in that state would not have access to the
newly approved therapy. In order to ensure timely access for people living with epilepsy, states should
begin now to take steps to eliminate any barriers that would delay the entry for an FDA approved
therapy derived from CBD into the marketplace.
When will FDA approved therapies derived from CBD become available?
The FDA is currently reviewing at least one CBD derived therapy (Epidiolex) that shows promise for
the treatment of Dravet and Lennox Gastaut syndromes, tuberous sclerosis complex (TSC) and
potentially other rare epilepsies. This potential treatment option has both Orphan Drug Designation and
Fast Track Designation from the FDA for Dravet syndrome and also Orphan Drug Designation for LGS
and TSC, another type of rare epilepsy. Given the Fast Track Designation, this potential treatment option
could be available as soon as early 2018. Since CBD is a Schedule I substance under most state
schedules, state action is needed to ensure proper rescheduling of FDA-approved treatments derived
from CBD.
For additional information and the latest on state rescheduling efforts visit
epilepsy.com/stateFDA pathway