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DEA Says No to Schedule II for Marijuana
Posted on September 5th, 2016 by Betsy Davis in Pharma R&D
This month, in response to petitions from the former governors of Rhode Island and Washington and from a psychiatric nurse in New Mexico, the U.S. Drug Enforcement Agency (DEA) announced its decision to keep marijuana classified as a Schedule I controlled substance. With medical marijuana now legal in 25 states, and the legalization of the drug’s recreational use passing in a handful of states, some thought the DEA might finally move marijuana to Schedule II status, which would have put it in the same category as drugs like Ritalin and oxycodone. But the DEA decided otherwise.
Forbes writer David Kroll contends that, “To some marijuana proponents, the decision fuels speculation that the FDA and DEA are favoring the pharmaceutical development of prescription products containing specific, isolated or synthetic marijuana components.”
But Chuck Rosenberg, acting administrator of the DEA, released the letter that he sent to the petitioners, and defended the decision, stating:
“Using established scientific standards that are consistent with that same FDA drug approval process and based on the FDA’s scientific and medical evaluation, as well as the legal standards in the CSA [Controlled Substances Act], marijuana will remain a schedule I controlled substance. It does not have a currently accepted medical use in treatment in the United States, there is a lack of accepted safety for its use under medical supervision, and it has a high potential for abuse.”
Is It Safe? Is It Beneficial?
Detractors of the DEA’s response, who are numerous, argue that to continue lumping marijuana in with more dangerous drugs like LSD and heroin is illogical. In another Forbes article, Emily Willingham points out that “Many plants make caffeine, the active ingredient in aspirin derives from willow bark, and digitalis, along with its cousin digoxin, are both used for heart conditions and come from foxglove. These plants obviously had much to offer in terms of clinically effective therapeutics. Like any medical intervention, each one also has its side effects. Yet none of these side effects—which range from gastric bleeding to death—has led to these plants being classified as a Schedule I drug.”
In his letter, Rosenberg is intent on making it clear that the classification isn’t just about whether or not marijuana is dangerous, but whether it can be scientifically proven that it actually has health benefits. Kroll responds to this, writing that “Denial of the medical value of marijuana is disingenuous, particularly in cancer pain or the nausea, vomiting and anorexia of cancer and cancer chemotherapy. In these cases, the FDA has already approved for medical use pharmaceutical products derived from marijuana.”
Growing the Research
Despite this setback, though, the good news for advocates of its medicinal use is that Rosenberg also said that they would be relaxing restrictions that had previously made it very difficult to study marijuana. So far, researchers have only been allowed to use marijuana grown in a single regulated facility at the University of Mississippi, but the DEA will now approve additional growers.
Although this olive branch to researchers is heartening, there is still concern that it will be difficult to ever obtain the proof that is being asked for. In an article in Science, health economist David Bradford explains, “That level of proof is never going to be forthcoming in the current environment because it requires doing a really extensive clinical trial series, and given that a pharmaceutical company can’t patent whole plant marijuana, it’s in no company’s interest to do that.”
From Farm to Pharma
However, there is one reason that businesses in the burgeoning pot industry might be relieved that the drug hasn’t been reclassified as Schedule II. “FDA regulation experts say if pot is placed in the same category as legal pharmaceutical formulations of opioids like oxycodone and stimulants like amphetamine, the burden of keeping up with regulatory compliance might be too costly for many of today’s small marijuana companies,” Will Yakowicz warned in Inc. prior to the DEA’s decision. “The marijuana industry as it exists today simply isn’t prepared for the rigors of transforming into a pharmaceutical industry.”
Anyone accustomed to wrestling with pharma’s expensive, complicated regulatory requirements may well agree that “Little Marijuana” has dodged a bullet. But it may not be long until they do move into the Big Pharma leagues. Maya Harris, a senior policy advisor for Hillary Clinton, recently said that Secretary Clinton would reclassify marijuana as a Schedule II substance if elected president. So the days of full legalization for marijuana – and all of the costs of legitimacy that come with it – may be soon to come.
All opinions shared in this post are the author’s own.
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