22 August 2016

Actually some very pertinent points made in this op-ed that we’d suggest would benefit law firms who are thinking about solutions for the pharma industry ahead of any federal changes that might come in 2017-2018

Motley Fool write

Yet the irony is that Clinton’s push to reschedule cannabis could actually wind up backfiring on the industry.

Rescheduling marijuana could backfire big-time

For as long as I can recall, the National Organization for the Reform of Marijuana Laws (NORML) and other non-profit organizations have been pushing for lawmakers to remove marijuana’s schedule 1 status, effectively legalizing and decriminalizing the drug at the federal level. If Clinton has her way, NORML and its peers would get that first step toward a possible full legalization. However, the move to schedule 2 could come at a mighty cost to the cannabis industry.

Current therapies that bear the schedule 2 designation include Oxycontin, Percocet, and morphine, to name a few. While these narcotics can be prescribed by a physician for pain management, they’re also tightly regulated by the U.S. Food and Drug Administration. The FDA is the regulatory body responsible for establishing medicinal efficacy, approving medicines, regulating the manufacturing process of drugs, and overseeing the accuracy of the marketing and package labeling of therapeutics. Moving marijuana to a schedule 2 classification would, in effect, move medical marijuana into the pharmaceutical business and place the industry under the tight and costly rules and regulations of the FDA.

For example, the FDA could require all packaging and labeling be run by it prior to retail sale in medical marijuana shops. Perhaps that’s not so bad, but it could certainly slow down the process through which medical marijuana makes it to store fronts.

Secondly, the FDA could tightly regulate the manufacturing process of medical marijuana grow farms. This could include ensuring that THC content from one grow to the next remains consistent and within certain guidelines. If growers aren’t abiding by the strict guidelines laid out by the FDA, then they could be subject to fines, and their crops may not make it to medical marijuana dispensaries.

Yet the most damaging aspect of a schedule 2 designation could be the possibility of clinical trials. The FDA is under no obligation to take the cannabis industry at its word that marijuana has a medically beneficial effect on epilepsy or pain, as an example. Instead, the FDA could require that medical marijuana growers, processors, and retailers prove that medical marijuana can meet these primary endpoints in a traditionally run and supervised clinical trial. Clinical trials can take a long time, and they can be extremely costly. Filing for drug approval alone is a significant added cost.

FDA regulation over the marijuana industry could be a nightmare. Smaller marijuana players that can’t afford the added regulatory costs could go out of business, while bigger businesses that can absorb those costs could take over. In theory, a rescheduling could give investors more legitimate ways to take part in marijuana’s growth story — but it could also inhibit competition and thereby raise the price of medical marijuana for consumers.

At the end of the day, liberating marijuana from its schedule 1 status could do more harm than good.

Read the rest of the op ed at