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The Department of Health and Human Services (HHS) has met the deadline for response to a medical marijuana advocacy organization’s petition calling for corrections to "scientifically flawed statements" contained in the HHS review of the Marijuana Rescheduling petition of 1995 with a 60 day extension request for further review by the Food and Drug Administration’s Center for Drug Evaluation and Research. The Center wrote that they will be consulting with the National Institute of Drug Abuse and Drug Enforcement Administration (DEA) in preparing their response.HHS reviews of controlled substances are normally written to inform the DEA.
Americans for Safe Access, a national coalition of patients and doctors working for easier access to marijuana for research and medical use, filed the challenge under the Federal Data Quality Act, a little-known but powerful law that gives people the right to challenge scientific information disseminated by federal agencies in a timely manner. If Americans for Safe Access is successful in its petition, correctional action by HHS would allow the Drug Enforcement Administration to remove marijuana from “Schedule I”, a category reserved for only the most dangerous drugs with no medical usefulness. Rescheduling marijuana would allow it to be prescribed for specified conditions and more easily obtained for research.
On Monday November 29th , the Supreme Court heard arguments for a medical marijuana case, Raich vs. Ashcroft. In the arguments, Justice Stephen G. Breyer said the plaintiffs in the case should have turned to the Food and Drug Administration to reclassify marijuana as appropriate for medical use; a refusal could then be the basis for a lawsuit charging the agency with abusing its discretion. Americans for Safe Access says they are doing trying to do just that, but such extensions are causing needless delays.
Steph Sherer, director of Americans for Safe Access, said, “This stalling tactic is unacceptable when patients’ health is at stake. We are simply asking for a fair review of the data they already have. It’s time for them to either admit that marijuana has accepted medical use, or deny our petition so we can move forward with challenging this ‘abuse of discretion’ in federal court.“ The two prior efforts to petition for marijuana rescheduling have dragged on for years, and a third effort is underway. The group says it will work to exert public and Congressional pressure over the next 60 days so as to avoid any further delays, and will take legal action if HHS does not respond in a timely manner to their challenge. A favorable ruling on the petition filed by ASA would at a minimum allow for a medical necessity defense to patients nationwide prosecuted on marijuana charges.
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For interviews or more information, contact Steph Sherer at (510) 872-7822, or Hilary McQuie (510) 333-8554. A national coalition of 10,000 patients, doctors and advocates, Americans for Safe Access is the largest organization working solely on medical marijuana. For more information, see www.safeaccessnow.org
Media inquiries may also be directed to:
Center for Drug Evaluation & Research, Acting Director Steven Galson; FDA Press Office 301.827-6250; Team Leader for Drugs Division Kathleen Quinn 301.827-3414
Full text of ASA's petition may be viewed at http://www.safeaccessnow.org/article.php?id=1465
Background on The Data Quality Act
& Summary of ASA’s Petition
The Data Quality Act (“DQA”) requires federal government agencies to employ sound science in making regulations and disseminating information. It also provides a mechanism for people and companies to challenge government information they believe to be inaccurate. Business, consumer, environmental and conservation groups have all used it to pursue changes in government policies.
Implementation of the Data Quality Act is the responsibility of a subdivision of the Office of Management and Budget, the OMB Office of Information and Regulatory Affairs. By October 2002, each federal agency was required to:
Issue its own information quality guidelines ensuring and maximizing the quality, objectivity, utility, and integrity of information that it disseminates;
Establish administrative mechanisms to allow affected persons to seek and obtain correction of information maintained or disseminated by the agency that does not comply with OMB or agency guidelines;
Report periodically to OMB the number and nature of complaints received by the agency regarding the accuracy of its information and how such complaints were resolved.
Americans for Safe Access (ASA) is both a co-petitioner in a rescheduling petition that is currently in front of HHS, and has filed a Data Quality Act petition with HHS and FDA asking for corrections to information printed in the Federal Register in 2001 regarding a denied rescheduling petition filed in 1995.
The petition is requesting make the following corrections to the HHS and FDA websites and to the Federal Registry:
1. “There have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition,” replaced with: “Adequate and well-recognized studies show the efficacy of marijuana in the treatment of nausea, loss of appetite, pain and spasticity.”
2. “A material conflict of opinion among experts precludes a finding that marijuana has been accepted by qualified experts” and “it is clear that there is not a consensus of medical opinion concerning medical applications of marijuana,” replaced with: “There is substantial consensus among experts in the relevant disciplines that marijuana is effective in treating nausea, loss of appetite, pain and spasticity. It is accepted as medicine by qualified experts.”
3. “A complete scientific analysis of all the chemical components found in marijuana has not been conducted,” replaced with: “The chemistry of marijuana is known and reproducible.”