Are the Political Winds Shifting for Medical Marijuana?

Specialty Pharmacy Times, January/February 2015, Volume 6, Issue 1

A recent congressional spending bill prohibits federal agents from raiding retail medical cannabis operations in states that allow medical marijuana.

A recent congressional spending bill prohibits federal agents from raiding retail medical cannabis operations in states that allow medical marijuana.

Today’s debate surrounding medical marijuana continues to be divisive. Currently, marijuana is classified as a Schedule I drug under the Controlled Substances Act (CSA). This means that it has: (1) no accepted medical use in the United States, (2) a lack of accepted safety for use under medical supervision, and (3) a high potential for abuse.1 Since this classification, there have been numerous efforts to get the drug rescheduled for a variety of reasons, including its use for medicinal purposes. Interested stakeholders—including physicians, elected officials, and advocacy groups—believe that medical marijuana should be allowed to treat symptoms of AIDS, multiple sclerosis, cancer, glaucoma, epilepsy, and pain. Opponents say marijuana usage, which is not FDA approved, can be dangerous and believe that the medical marketplace has other prescriptions available to remedy these aforementioned conditions. This discussion will examine current medical marijuana policies and whether changing attitudes will have any effect on future oversight of the drug.

The first question to consider: what is medical marijuana? The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health and US Department of Health and Human Services (HHS), is charged with overseeing the cultivation, production, and distribution of research-grade marijuana on behalf of the US government. NIDA states that medical marijuana refers to the whole unprocessed marijuana plant or its crude extracts, which are not recognized or approved for use as medicine by the FDA.2

Cannabinoids are active chemicals contained within marijuana that have been used in the development of 2 FDA-approved medications and may lead to the development of future medications. Scientists have identified 2 cannabinoids of interest out of the more than 100 within the marijuana plant that may have medicinal value. Tetrahydrocannabinol, the plant’s psychoactive ingredient, stimulates appetite and reduces nausea, but may also decrease pain, inflammation, and spasticity. The other, cannabidiol, may reduce pain and inflammation, control seizures, and treat psychosis and addictions.2 While these initial observations sound promising, debate continues as to whether these potential benefits outweigh the significant risks posed to patients who use these substances as medication.

Current federal policies on medical marijuana have been conflicting. In 2009, medical marijuana advocates expressed optimism after the release of a 2009 Department of Justice (DOJ) memorandum dubbed the “Ogden memo.”3 This document was distributed to federal prosecutors in states that implemented marijuana laws. While the memo was far from expressing support for marijuana use, the DOJ emphasized its commitment to “the prosecution of significant traffickers…and the disruption of illegal drug manufacturing and trafficking networks.” Furthermore, the memo emphasized that federal resources should not be focused on “individuals whose actions are in clear and unambiguous compliance with existing laws providing for the medical use of marijuana.”

However, confusion became more widespread after the Ogden memo circulated as the Drug Enforcement Administration (DEA) and Office of US Attorneys continued to aggressively raid and prosecute state-approved marijuana providers. In response, on June 29, 2011, the DOJ issued a clarification dubbed the “Cole memo,” which appeared to walk back the Ogden memo by expressing that medical marijuana dispensaries would be considered targets for prosecutors and drug investigators. The memo stated, “Persons who are in the business of cultivating, selling, or distributing marijuana, and those who knowingly facilitate such activities, are in violation of the Controlled Substances Act, regardless of state law. Consistent with resource constraints and the discretion you may exercise in your district, such persons are subject to federal enforcement action, including potential prosecution. State laws or local ordinances are not a defense to civil or criminal enforcement of federal law with respect to such conduct, including enforcement of the CSA.”4 One can only imagine the potentially chilling effect this kind of enforcement could have by making it almost impossible for a patient to gain access to marijuana since dispensaries could be prosecuted under federal law.

The DEA has remained steadfastly against marijuana. Marijuana advocates and interested stakeholders claim that the DEA has created a virtual “Catch 22,” as its position is that the drug has no medical value, yet researchers must get approval from the DEA to research whether medical value exists. Needless to say, research has been sparse.

However, this past spring, NIDA notified the DEA that it required 600 kilograms of marijuana to be manufactured to provide for current and anticipated research,5 which is a significant increase over the 21 kilograms that had been previously allowed. The request, in the process of being approved, derives from increased interest in determining whether the drug has any therapeutic potential. Additionally, the FDA has weighed in on the discussion via congressional testimony and a helpful Q&A on its website. While the FDA has not approved a marketing application for marijuana for any indication, it has approved Marinol (dronabinol) and Cessamet (nabilone) for therapeutic uses. Overall, the agency believes that scientifically valid research conducted under an investigational new drug application is the best way to determine which patients could benefit from the use of drugs derived from marijuana.6

All of the back and forth over this issue in 2014 suggests that Congress may be best positioned to determine the direction of this debate. Last summer, a group of bipartisan congressional representatives sent a letter to HHS secretary Sylvia Matthews Burwell seeking to make the process for obtaining marijuana for medical research less cumbersome. The letter came after an earlier House vote to block the DEA from using funds to go after medical marijuana operations that are legal under state law. Senator Rand Paul (R-KY) has also filed an amendment to S.2569 (known as the “Bring Jobs Home Act”) which would protect the patients and doctors acting in accordance with state laws that exempt medical marijuana use from federal prosecution. Additionally, HR 5226, the Charlotte’s Web Medical Hemp Act of 2014, sponsored by Congressman Scott Perry (R-PA), also had many stakeholders talking. The bill sought to amend the CSA “to exclude therapeutic hemp and cannabidiol: (1) from the definition of ‘marijuana’ and (2) from treatment as a controlled substance under such Act.” However, it was Congress’ last act of the year that most excited many medical marijuana activists. Contained within the $1.1-trillion spending bill that halted a potential government shutdown is a provision that prohibits federal agents from raiding retail medical cannabis operations in states that have legalized medical cannabis.7 This represents a huge policy shift for Congress.

So, what happens now? Congress’ latest action creates a more predictable policy field for medical marijuana advocates, as a new administration that could potentially oppose medical marijuana would have difficulty reversing this precedent. However, there is still work to be done by advocates. While supporters of medical marijuana should be optimistic about their successes on the state and federal level, they will still have to convince other states that have not considered passing legislation allowing medical marijuana. Furthermore, while the aforementioned congressional victory is exciting for medical marijuana advocates, the DEA still classifies marijuana as a Schedule I drug, which means that it is technically illegal. In order to erase all doubts on medical marijuana, advocates will want to look at pushing Congress to change marijuana to a Schedule II drug. Lastly, advocates will have to contend with public opinion. While opposing opinions should not be ignored, it seems that allowing scientific research to determine what therapeutic qualities marijuana may possess will be the best way to finally sway the court of public opinion. SPT

References

  • Drug Enforcement Administration, Office of Diversion Control. Controlled substance schedules. www.deadiversion.usdoj.gov/schedules.
  • National Institute on Drug Abuse. Drug facts: is marijuana medicine? www.drugabuse.gov/publications/drugfacts/marijuana-medicine. Revised December 2014.
  • US Department of Justice, Office of the Deputy Attorney General. Memorandum for selected US attorneys. October 19, 2009. www.justice.gov/sites/default/files/opa/legacy/2009/10/19/medical-marijuana.pdf.
  • US Department of Justice, Office of the Deputy Attorney General. Memorandum for US Attorneys. June 29, 2011. www.justice.gov/sites/default/files/oip/legacy/2014/07/23/dag-guidance-2011-for-medical-marijuana-use.pdf .
  • Drug Enforcement Administration. Controlled substances: adjustment to the established 2014 aggregate production quota for marijuana. Federal Register. 2014;79(86):25620-25621. www.gpo.gov/fdsys/pkg/FR-2014-05-05/html/2014-10202.htm.
  • FDA and marijuana: questions and answers. FDA website. www.fda.gov/newsevents/publichealthfocus/ucm421168.htm. Updated October 30, 2014.
  • Pub L No. 113-235. www.congress.gov/bill/113th-congress/house-bill/83/text.

About the Author

Ron Lanton III, Esq, is president of True North Political Solutions, LLC. He has over 20 combined years of government affairs and legal experience. This includes activities on the municipal, state, and federal levels of government. Most recently, he worked for a pharmaceutical wholesaler where he created and oversaw the company’s government affairs department, served as their exclusive lobbyist, and advocated for the company’s various health care customers. Prior to that, Ron worked at a government affairs consulting firm in Arlington, Virginia, where he focused on health care, energy, commerce, and transportation issues. He has also clerked for a federal magistrate, was appointed as a municipal commissioner on environmental issues, and has served as consultant to Wall Street firms on financial issues. He has been a featured industry speaker on issues such as pharmaceutical safety and health care cost containment. Ron earned a Juris Doctor from The Ohio State University Moritz College of Law and a Bachelor of Arts from Miami University of Ohio. He is also a “40 under 40” award recipient. He has been admitted to practice law in New York, Illinois, and the District of Columbia.