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12/8: HHS Stalls on Medical Marijuana Decision
by Americans for Safe Access
Thursday Dec 9th, 2004 11:45 PM
HHS Stalls on Medical Marijuana Decision
Heat Turning Up on Government to Correct 'Medical Marijuana Misinformation'


For Immediate Release: December 8, 2004

Media Contact: Hilary McQuie 510.333-8554



HHS Stalls on Medical Marijuana Decision
Heat Turning Up on Government to Correct 'Medical Marijuana Misinformation'


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 arguements for another medical
marijuana case, Raich vs. Ashcroft. In the arguments, Justice Stephen G. Breyer
said the plaintiffs in the case should turn 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.

# # # #



For interviews, 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 http://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

______________________________________________________________________________________________



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.”



4. HHS states that marijuana “has no currently accepted medical use in treatment in
the United States,” replaced with: “Marijuana has a currently accepted use in
treatment in the United States.”

Full text of ASA's petition may be viewed at
http://www.safeaccessnow.org/article.php?id=1465

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