New FDA Bill: Blow to Medical Marijuana?

Brian Doherty | May 14, 2007

From the Politico, via Americans for Safe Access. Right before the vote on the new drug safety bill that passed the Senate last week (extending FDA authority over the lifecycle of a drug, not just prior to approval):

An amendment by Tom Coburn (R-Okla.) was adopted that required marijuana to undergo the same Food and Drug Administration approval process that other prescription drugs do.

Until this process is accomplished -- and it typically takes about five years -- those in the medical marijuana business apprehended by federal authorities could face penalties for violating FDA regulations as well as selling an illegal substance, even where state laws sanction the use. [Medical pot] activists say the conservative senator clearly intended to shut down medical marijuana cooperatives.....

Steph Sherer, founder and executive director of Americans for Safe Access, which advocates for medical marijuana only, said her group learned of Coburn's amendment the night before the markup.

Her staff called members of the panel to try to dissuade them from approving the amendment, and she said everyone they talked to voted against it. She's hopeful that Tom Harkin (D-Iowa) and Jeff Bingaman (D-N.M.), who voted with Republicans for the amendment, will change their minds.

Karen Woodson, ASA's director of government affairs, said Coburn's amendment is about prohibition, not regulation. The tests necessary to secure FDA approval would be impossible to conduct, she explained, because the Drug Enforcement Administration and the National Institute for Drug Abuse don't give researchers permission to grow marijuana.

Comments

Ramsey|5.14.07 @ 10:40AM|#

I fail to see how a plant that can grow in the ditches of most of the US can be classified as a prescription drug. The active ingredients can, but how can the plant?

I should start smoking this stuff, maybe if I was stoned the war on pot would make more sense.

|5.14.07 @ 11:18AM|#

God created nature. Churchianity wants pot illegal and nature be damned.

bourgeoiscowboy|5.14.07 @ 11:45AM|#

I don't understand how or why anyone is against medical marijuana in the first place - I'm surprised this issue can be used for political leverage at all.

|5.14.07 @ 12:07PM|#

"I fail to see how a plant that can grow in the ditches of most of the US can be classified as a prescription drug."

Good call.

Pharmaceutical companies have teams of people running around the four corners of the Earth collecting roots and berries and scraping slime from the backs of frogs to analyze the active chemicals because, it turns out, one cannot patent something that they've found in nature (patents are designedto protect intellectual property). They then reverse engineer the active ingredients and, if they can, recreate the agent in the lab. Then, and only then, can someone apply for a patent and FDA approval. Big Pharma makes a lot of its money on royalties paid as a result of their "ownership". I wouldn't be surprised if this bill wasn't sparked by someone at Pfizer or UpJohn.

It seems to me that if you can't patent it then it's can't be under the control of the FDA but I could be wrong.

|5.14.07 @ 2:06PM|#

I really don't understand why government types are so dead-set against marijuana. What is it with these guys? I've never seen such an irrational aversion.

|5.14.07 @ 2:11PM|#

The main bill itself is far more dangerous than the medical weed amendment attached to it. So I think we should applaud it only in the hopes that hopefully can give lawmakers another reason to vote against the Bill itself.

LarryA|5.14.07 @ 2:47PM|#

I really don't understand why government types are so dead-set against marijuana. What is it with these guys? I've never seen such an irrational aversion.

Not aversion, fear. MJ is a gateway drug. As people start to take it and everyone notices there aren't any ill effects, it will call the whole war on drugs into question.

|5.14.07 @ 2:54PM|#

I really don't understand why government types are so dead-set against marijuana. What is it with these guys? I've never seen such an irrational aversion.

Because once we accept that a substance is safe enough to give to a cancer patient, then it might create the impression that it is safe for a healthy individual, and in some way might lead to the legalization of pot.

Since the police-industrial complex is driven by the war on drugs, that it a terrifying danger.

|5.14.07 @ 3:38PM|#

So I think we should applaud it only in the hopes that hopefully can give lawmakers another reason to vote against the Bill itself.

Sadly, it will probably have the opposite effect, making it harder to oppose the main bill without being tagged as soft on drugs.

Robert|5.14.07 @ 4:09PM|#

Either the news report is garbled or the bill itself is. Maybe both.

"An amendment by Tom Coburn (R-Okla.) was adopted that required marijuana to undergo the same Food and Drug Administration approval process that other prescription drugs do."

But that's already the case. There's no exception in the FFDCA for cannabis now. The only mention of cannabis in the existing Act is that a drug containing cannabis has to be prescription, not OTC, and labeled as possibly habit forming.

"those in the medical marijuana business apprehended by federal authorities could face penalties for violating FDA regulations as well as selling an illegal substance, even where state laws sanction the use."

The FFDCA already allows a presumption of interstate commerce in seizures of drugs & devices, although that presumption is rebuttable. But as far as penalties, there are none if the article is not in interstate commerce or being prepared for introduction to interstate commerce. If interstate commerce is established -- a question of fact -- FDA can go after med mj suppliers without any further legislation.

So I don't see how the amendment as described would change anything in terms of med mj.

bruce|5.14.07 @ 8:51PM|#

THC is already FDA approved when combined with sesame seed oil in a gelcap (Marinol pills). I don't see how the active chemical in pot can be FDA approved but pot itself can't. But it's not like drug laws make any sense to begin with.

Robert|5.14.07 @ 9:27PM|#

It's because food & drug law as currently constituted in most respects (and exclusive of controlled substances) deals with articles of commerce, not substances per se. The "drug" is the whole package -- its ingredients (active & inactive), packaging, labeling, and even to some extent its marketing.