by Bruce Mirken
In its official response to the AMA’s recent call for a review of marijuana’s status as a Schedule I drug (barring any medical use) under federal law, the White House Office of National Drug Control Policy stated that it would defer to “the FDA’s judgment that the raw marijuana plant cannot meet the standards for identity, strength, quality, purity, packaging and labeling required of medicine.”
While we’re not used to factual accuracy from ONDCP, in this case they’re wrong not once, but twice.
First, there is absolutely no reason that plant medicines can’t be standardized and controlled for purity and potency. Indeed, the Netherlands has been doing just that for years, with medical marijuana distributed in Dutch pharmacies that is “of pharmaceutical quality and complies with the strictest requirements,” according to the Dutch government.
Second, the FDA has never said that a natural plant product can’t be a medicine. Indeed the agency has a lengthy “Guidance for Industry: Botanical Drug Products,” specifically designed to aid developers of plant medicines. The document not only doesn’t rule out plants as medicines, it even states, “In the initial stage of clinical studies of a botanical drug, it is generally not necessary to identify the active constituents or other biological markers or to have a chemical identification and assay for a particular constituent or marker.” Given that the active components of marijuana are already well-known and extensively researched, marijuana is well ahead of where the FDA says plant products need to be to start the process of seeking FDA licensing.
Yes, the FDA did put out a press release in 2006 saying that “smoked marijuana” had not been shown to be a safe and effective medicine. That statement was utterly unscientific, as we pointed out at the time, but it was absolutely not a declaration that the plant could never be a medicine.
by Bruce Mirken