For Immediate Release: December 8, 2004
Media Contact: Hilary McQuie 510.333-8554
The Department of Health and Human Services (HHS) has met the deadline
for response to a medical marijuana advocacy organizations 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
Administrations 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. Its
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
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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