The controversy caused by President Obama lying about his ability to reschedule marijuana has sparked a debate about how important such a move would really be. For example, Professor Mark Kleiman claims it would have almost no impact because there is currently no FDA approved marijuana. From Kleiman:
Yes, authority to reschedule cannabis lies with the Administration. If the DEA Administrator decided that the drug had “accepted medical use,” that would move it to Schedule II, making cannabis legally available by prescription. Selling it without a prescription would remain the same crime it is today. (Recall that cocaine and methamphetamine are Schedule II drugs.)
But prescriptions can only be written for FDA-approved drugs. And the FDA can’t approve “marijuana,” because “marijuana” isn’t something that can be put through clinical trials. The New Drug Application would have to be for a specific cannabis preparation, to be given in a specific dosage regimen via a specific route of administration for the treatment of a specific condition. That “new drug” could be a single molecule a combination, an herbal preparation, or an extract. In any case, it would have to have a known and reproducible chemical composition and be produced using “Good Manufacturing Practice.” Producing cannabis without FDA approval would still be the illegal manufacture of a Schedule II controlled substance.
So administrative rescheduling would not make “medical marijuana,” or any other kind, legal at the federal level. Its practical effect would be identically zero.
This is just circular logic. It is an absurd catch-22 that has always hampered medical marijuana at a federal level.
I would argue that the main reason there is no herbal preparation of whole marijuana that is approved by the FDA is because the administration has made it clear they don’t support medical marijuana, regardless what research shows.
The administration has repeatedly made it clear they have an irrational and incredibly hostile attitude toward medical marijuana. They have done this primarily by resisting calls to even consider new medical marijuana research. The DEA sat on a rescheduling petition for a decade and only issued a final determination against it when effectively compelled by the court to do so. Their decision unacceptably ignored the science. In addition, the administration has actively prevented research that was approved by the FDA.
The bottom line is that the administration has clearly signaled to companies that it would be a complete waste of time and money to try to get an herbal preparation of marijuana approved by the FDA. If the administration would prove they no longer refuse to acknowledge the medical benefits of marijuana by moving it to a lower schedule, I strongly suspect we would see companies trying to get FDA approval. Government-approved medical marijuana producers in Israel or Canada would be some logical candidates.
Public policy is always an interlocking set of cogs. Technically, you can point out how moving one item in total isolation wouldn’t do much, but every process starts somewhere — you have to get the other cogs turning.
Kleiman argues rescheduling won’t make a difference because there is no FDA-approved marijuana preparation, but there is no FDA-approved marijuana in large part because the administration refuses to reschedule it, and now the lack of FDA-approved marijuana is used as an excuse for not rescheduling it.
Jon Walker is the author of After Legalization: Understanding the future of marijuana policy