In a 28-page decision, the US Court of Appeals for the District of Columbia Circuit has denied petitioners request to overturn the July 2011 denial by the Drug Enforcement Administration to initiate proceedings to reschedule marijuana under federal law.
In October 2002, the Coalition to Reschedule Cannabis, a coalition of reform organizations including NORML, ASA, Patients Out of Time and High Times, among others, petitioned the DEA to reschedule marijuana as a Schedule III, IV, or V drug. Following years of administrative delay, on July 8, 2011, the DEA denied the petition, finding that “[t]here is no currently accepted medical use for marijuana in the United States,” and that “[t]he limited existing clinical evidence is not adequate to warrant rescheduling of marijuana under the CSA.”
Petitioners then sought review in the federal Court of Appeals, alleging the decision by the DEA was arbitrary and capricious when it concluded that marijuana lacks a “currently accepted medical use” and has a “high potential for abuse.” They ask this court to remand the case to the DEA for reconsideration of its decision.
Written by Senior Circuit Judge Edwards, the decision ruled “On the record before us, we hold that the DEA’s denial of the rescheduling petition survives review under the deferential arbitrary and capricious standard. The petition asks the DEA to reclassify marijuana as a Schedule III, IV, or V drug, which, under the terms of the CSA, requires a ‘currently accepted medical use.’ The DEA’s regulations, which we approved in Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), define ‘currently accepted medical use’ to require, inter alia, ‘adequate and well-controlled studies proving efficacy.’ Id. at1135. We defer to the agency’s interpretation of these regulations and find that substantial evidence supports its determination that such studies do not exist.
“In its scientific and medical evaluation,” the court held, “DHHS concluded that marijuana lacks a currently accepted medical use in the United States. In reaching this conclusion, DHHS applied the DEA’s established five-prong test, which requires a known and reproducible drug chemistry, adequate safety studies, adequate and well-controlled studies demonstrating efficacy, acceptance of the drug by qualified experts, and widely available scientific evidence.”
“We will not disturb the decision of an agency that has ‘examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made.’”
In this case, we need only look at one factor, the existence of “adequate and well-controlled studies proving efficacy,” to resolve Petitioners’ claim.
At bottom, the parties’ dispute in this case turns on the agency’s interpretation of its own regulations. Petitioners construe “adequate and well-controlled studies” to mean peer-reviewed, published studies suggesting marijuana’s medical efficacy. The DEA, in contrast, interprets that factor to require something more scientifically rigorous.
In making this assessment, we must “remind ourselves that our role in the Congressional scheme is not to give an independent judgment of our own, but rather to determine whether the expert agency entrusted with regulatory responsibility has taken an irrational or arbitrary view of the evidence assembled before it.
The DEA’s construction of its regulation is eminently reasonable. Therefore, we are obliged to defer to the agency’s interpretation of “adequate and well-controlled studies.” Judged against the DEA’s standard, we find nothing in the record that could move us to conclude that the agency failed to prove by substantial evidence that such studies confirming marijuana’s medical efficacy do not exist.”
Petitioners are considering their legal options at this time.
The U.S. Court of Appeals for the D.C. Circuit will hear opening arguments next week in a lawsuit challenging the federal government’s refusal to consider reclassifying cannabis as a schedule I prohibited substance under federal law.
At issue in the case is whether the Drug Enforcement Administration (DEA) acted appropriately when the agency last year denied an administrative petition – initially filed by a coalition of public interest organizations, including NORML, in 2002 – that called on the agency to initiate hearings to reassess the present classification of cannabis.
Under federal law, schedule I substances must possess three specific criteria: “a high potential for abuse;” “no currently accepted medical use in treatment;” and “a lack of accepted safety for the use of the drug … under medical supervision.” In its 2011 denial of petitioners’ rescheduling request, DEA Administrator Michele Leonhart alleged that cannabis possesses all three criteria, claiming: “[T]here are no adequate and well-controlled studies proving (marijuana’s) efficacy; the drug is not accepted by qualified experts. … At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”
By contrast, a recent scientific review of clinical trials evaluating the safety and efficacy of cannabis concluded, “Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.”
Commenting on the upcoming hearing in a press release, Joe Elford, Chief Counsel with Americans for Safe Access (ASA) said: “Medical marijuana patients are finally getting their day in court. What’s at stake in this case is nothing less than our country’s scientific integrity and the imminent needs of millions of patients.” Elford will be arguing the case before the D.C. Circuit. Oral arguments in the case are scheduled for Tuesday, October 16th.
NORML previously filed a similar rescheduling petition with the DEA in 1972, but was not granted a federal hearing on the issue until 1986. In 1988, DEA Administrative Law Judge Francis Young ruled that marijuana did not meet the legal criteria of a Schedule I prohibited drug and should be reclassified. Then-DEA Administrator John Lawn rejected Young’s determination, a decision the D.C. Court of Appeals eventually affirmed in 1994.
A subsequent petition was filed by former NORML Director Jon Gettman in 1995, but was rejected by the DEA in 2001.
Further information on the lawsuit is available at: http://safeaccessnow.org. Additional information on the 2002 petition to reschedule cannabis is available at: http://www.drugscience.org/.
Despite last week’s defeat of Proposition 19 at the polls, new taxes on marijuana are coming to California.
As I write today in High Times online, California voters on election day by wide margins endorsed citywide medical marijuana tax ordinances in Albany, Berkeley, La Puente, Oakland, Rancho Cordova, Richmond, Sacramento, San Jose, and Stockton. You can read the full details of each of these tax measures, as well as Los Angeles’ latest medi-pot tax plan, here.
While the bulk of these new tax plans impose fees on the dispensaries themselves — fees that will no doubt indirectly be passed on to the consumer via higher retail prices for cannabis — at least one plan (Rancho Cordova’s Measure O) seeks to impact patients directly by instituting local fees on personal home grows.
While it is possible (read: likely) that this exorbitant fee will be eventually struck down by the courts as an undue infringement upon patients’ rights under Prop. 215, it could be months or years before such a clarification by the courts is made.
Patient advocacy groups like Americans For Safe Access oppose the implementation of such medi-tax laws, noting that they could unduly raise the already inflated black market price of medical cannabis, lead to fewer dispensaries, and ultimately limit patients’ access. Nonetheless, it is hardly surprising to see a majority of Californians, at a time of record budget deficits, voting to impose additional taxes upon a minority subset of their community.
In short, the success of these tax measures at the ballot box is yet further evidence that with or without Prop. 19, more and more city governments — rightly or wrongly — are going to be looking at new ways to raise revenue from California’s burgeoning cannabis industry and its consumers. Industry insiders and those they represent, patients especially, would be best advised to begin playing an active role in their local politics, or else risk suffering the consequences of unreasonable taxation without representation.
You can read my full thoughts on this developing issue, and comment on it, by clicking here: Like It Or Not, Pot Taxes Are Coming to California.