Marijuana And The FDA
Why is FDA approval required for legal access to drugs including marijuana?
FDA approval is required for access to certain drugs because the government decided, in the early 1900s really, to start regulating the flow of medicine to people. So in the early 1900s, you started to see the first attempts at Congress and the President, and the government generally trying to regulate the production and the marketing and the distribution of drugs to people who wanted them. And we've seen many evolutions of how this system has worked. The FDA itself actually underwent a major overhaul in the mid-90s when Congress passed the Prescription Drug User Fee Act, and the Prescription Drug User Fee Act actually allowed the companies to pay a fee to the FDA, the drug companies that want to speed their drugs to approval, to pay a fee to the FDA, which would then allow the FDA to pay for more manpower and to pay for more resources, for more reviewers of the applications, for more safety experts. What we know now is that the FDA did not step up its focus on safety at all. It was primarily concerned, it seems, with speeding drugs to approval. Where this all comes in with marijuana is that marijuana needs to undergo an FDA approval process. It needs to undergo an investigational new drug application and Phase I, II, and III clinical trials at some point for it to actually be considered a pharmaceutical that can be prescribed by doctors.
Has the FDA studied marijuana?
The FDA has issued a very political, politicized statement about medical marijuana at one point, not based on any new science, not based on any review of current data. Basically based on the whim of one congressman and the Bush administration, who hate this issue. So what the FDA has put out was not scientific. Now I guess that should be a surprise to anybody who really follows the FDA and follows this administration's record on science. However it is not the case that the FDA has done any review and they have not rejected medical marijuana. In fact they haven't even taken an application in the door for it to begin with. So when our opponents claim that its been tried and rejected or studied and rejected, its just an absolute lie.
