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HHS Stalls on Medical Marijuana Decision

   

  Heat Turning Up on Government to Correct 
    'Medical Marijuana Misinformation'
 

         Return To OnlinePot’s Legal Section Main Page       

 

    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