With so many conditions and medical applications, what is the link between Cannabis and the Right to Try Act? As with so many other instances, the answer is complicated.
What is The Right to Try Act?
The Right to Try Act was made to established to offer accessibility to investigational drugs directly from the companies who develop them, before the drugs or therapies have been approved by the FDA for use for that specific indication. The FDA is not involved in these interactions, but it does allow them to take place under the guidelines established. The decisions and requests are made directly to the manufacturers by the patients and their health care teams. It is up to the companies to decide if they want their products included in the program, and to make the final decisions on a case-by-case review.
What’s the Impact of Cannabis and the Right to Try Act?
- The short answer is: It’s not eligible.
- The explanation is a bit more elaborate.
So is Cannabis included?
Not really, no. In order to qualify under the “Right to Try”, an eligible patient has to have been diagnosed with a life threatening disease or condition and have used all other options currently available without success. The patient also has to be deemed ineligible for any clinical trials.
But the main requirement for “Right to Try” is that a drug must have completed the Phase 1 FDA clinical trial process. So that means pretty much no. The only products that may be eligible would be Epidolex, which has been approved for seizure disorders, and may be under additional investigation and trials for other uses. Marinol and Syndros are two other products that are under consideration and research with the FDA so there may be considerations granted for those, as well.
For current information on trials and studies for medical marijuana, click here »