The FDA and Medical Marijuana

The Food and Drug Administration (FDA) scored a public relations coup on April 20th with a one-page news release that merely restated longstanding administration policy regarding the medical use of marijuana. This old news was packaged by the media as new news, and much of the coverage reinforced the misimpression that FDA’s release reported the results of some recent investigatory process. The good news, ignored by the media and most of the movement, is that a current FDA review of marijuana’s medical properties remains underway.

In fact, the “Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is Medicine” plainly stated that it was based on “a past evaluation by several Department of Health and Human Services [HHS] agencies.” One such evaluation, and the likely evaluation referred to in the advisory, took place in response to my 1995 rescheduling petition. This HHS/DEA evaluation was flawed in several respects, including its failure to even address the issue of accepted medical use. The evaluation of the 1995 petition, frequently used to provide a scientific justification for marijuana’s ongoing schedule I status, was never subjected to judicial review, and by no means represents closure on the issue of marijuana’s medical use.

Indeed much has happened since the 1995 rescheduling petition, including the filing of an updated and advanced rescheduling petition in 2002. The 1995 petition relied on scientific literature regarding marijuana’s potential for abuse. The 2002 petition, though, focuses more concisely on the issue of accepted medical use and the presentation of relevant scientific and medical evidence was enhanced by the contributions of a number of experts. Background materials on both rescheduling petitions are available at http://www.drugscience.org.

The current rescheduling petition was referred by the Drug Enforcement Administration (DEA) to HHS in the summer of 2004 for a complete scientific and medical evaluation, as required by the Controlled Substances Act. This HHS review is currently underway, and is being conducted, in part, by the same Food and Drug Administration that issued the news release that past evaluations have found that smoked marijuana is not medicine. Please note now, for the record, that FDA’s 4/20/06 announcement neglected to mention that the agency is currently conducting a new evaluation of whether or not marijuana’s medical use has been accepted in the United States – the evaluation of the 2002 rescheduling petition I filed along with the Coalition for Rescheduling Cannabis.

The federal government has long held, as a matter of legal and regulatory doctrine, that - for the purposes of regulating drugs under the Controlled Substances Act - nothing is medicine unless the DEA says it is medicine. In more precise terms, the DEA argues that accepted medical use under the Controlled Substances Act requires FDA approval of a drug under the provisions of the Federal Food, Drug, and Cosmetic Act. The problem with this argument is that it has already been struck down by the US Court of Appeals in NORML v. DEA (1977). The Appeals Court ruled that recognition of accepted medical use for the purposes of scheduling under the CSA does not require prior FDA approval of medical use.

Let’s pause for a second and make this simple. The government (DEA, FDA, etc) argues that marijuana is not medicine because they say it is not medicine. The courts, though, have a different opinion on the matter. When it comes to how the Drug Enforcement Administration regulates drugs under the Controlled Substances Act the government’s job is to determine if a drug has accepted medical use. That means accepted by medical and scientific professionals, not accepted by the DEA.

When it comes to assessing whether or not marijuana has accepted medical use in the United States both DEA and the FDA have a legal obligation to assess whether it has been accepted by health care and medical professionals as well as to assess the scientific evidence recognized as valid by those professionals.

Which brings us back to the current review being conducted by HHS and FDA – the current review of the 2002 CFR rescheduling petition must consider all available scientific and medical evidence. They can’t rely on their flawed “past” evaluations to reject the evidence in the current petition and in the contemporary scientific record.

When the current review is complete HHS will return the rescheduling petition to DEA. The CSA authorizes DEA to collect any additional relevant information at that time. When DEA is finished adding what it wishes to the official record the agency’s decision will be published in the Federal Register and subjected to public comment. At that time people affected by the DEA’s decision can seek review of matters of fact by an administrative law judge or judicial review of matters of law by the U.S. Court of Appeals.

Meanwhile the review of marijuana’s medical use by the scientific staff at FDA continues, regardless of the pronouncements of the public affairs office and perhaps, even, in spite of it. Let’s not rush to judgment on the topic of the FDA and medical cannabis. We know what the political and public affairs staff of the agency thinks about the subject, but let’s wait and see what the scientists now evaluating the CFR petition have to say on the matter before making a final assessment about the FDA’s dedication to science and the public policy process.