From Mark McCoy, SVP, Brand Planning Director, Palio
Recent developments have opened up a better, faster, cheaper route to market for new medicines. Marketers should seriously consider the medical marijuana commercialization path as an alternative to the tradition route to market via the FDA approval process.
Medical Marijuana Indications
Consider the status of medical marijuana in the state of New Mexico today. Marijuana is approved for use in 15 disease indications in that state.
| Amyotrophic Lateral Sclerosis | Hospice patients |
| Cancer | Inflammatory autoimmune-mediated arthritis |
| Crohn’s disease | Intractable nausea/vomiting |
| Damage to the nervous tissue of the spinal cord with intractable spasticity | Multiple sclerosis |
| Epilepsy | Painful peripheral neuropathy |
| Glaucoma | Post-traumatic stress disorder |
| Hepatitis C infection currently receiving antiviral treatment | Severe anorexia/cachexia |
| HIV/AIDS | |
8-Member Board Provides Approvals
The approval process for gaining a new indication for medical marijuana is much less rigorous than the process required by the FDA. For example, according to the New Mexico Independent, Representative Sal Pace said, “An eight-member board of physicians in New Mexico just verified that medical marijuana does assist fight (sic) the symptoms of PTSD.” The pharma industry could save billions in R&D costs every year, by gaining approval of the 8 New Mexico physicians instead of the FDA.
Trend Is Sweeping the Nation
New Mexico is not alone. There are 14 states that currently allow the use of medical marijuana: Alaska, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington. Many other states are considering making marijuana legal.
Precedent for Bypassing FDA
For the pharma industry, the legalization and commercial sale of medical marijuana represents a tremendous precedent. The states have allowed a drug to be sold and promoted for the treatment of extremely common diseases without the benefit of any FDA approval or oversight.
New Competitive Advantage?
A pharma company wishing to sell a new drug for glaucoma, for example, could follow the medical marijuana route to market. This new glaucoma drug could gain breath-taking advantages over its competition. The glaucoma drug maker could conduct minimal or no clinical trials, realizing vast savings in time and money. The company could forgo Good Manufacturing Processes (GMPs) and the need for Prescribing Information (PI). If challenged, the pharma company could argue that they are merely following the same process used by a previous drug that is also approved and sold for the treatment of glaucoma. It could not be argued that marijuana is an herb or a botanical and not a drug, since marijuana is classified as a class 1 narcotic by the federal government.
The Spark For A Pharma Industry Boom?
It would be fascinating to see a net present value analysis for a new a drug comparing the profitability of the commercial asset if it were developed through the traditional FDA route or the wide open medical marijuana route. If this new route to market were exploited by the industry, patients, physicians and investors would all benefit handsomely.
Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.
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