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®: CRE Regulatory Action of the Week

HHS' Medical Marijuana Paradox
In the space of little more than a week, HHS issued two contradictory statements on medical marijuana. On April 12th, HHS issued their sixth delay in deciding an appeal by Americans for Safe Access (ASA) of an initial agency decision, reached after three extensions, denying the medical marijuana advocacy organization's October 2004 Data Quality petition. The ASA petition requested correction of HHS statements claiming that "marijuana has no currently accepted medical use in treatment in the United States." HHS cited only procedural, not scientific, reasons for rejecting the ASA Data Quality petition.

As the case with HHS' five previous extensions for deciding ASA's Request for Reconsideration, the agency stated that they needed "additional time to coordinate Agency review."

On April 20th, the one year anniversary of the Department's denial of the ASA Request for Correction, HHS issued an "Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine." Despite the Department's assertion the previous week that yet more time was needed "to coordinate agency position," the Advisory flatly states that HHS agencies, "concluded that no sound scientific studies supported medical use of marijuana for treatment in the United States...."

FDA's Inter-Agency Advisory refutes the Department's only stated justification for repeatedly delaying a decision on the ASA appeal. Furthermore, as explained in The New York Times, the Advisory "directly contradicts a 1999 review by the Institute of Medicine, a part of the National Academy of Sciences, the nation's most prestigious scientific advisory agency. That review found marijuana to be "moderately well suited for particular conditions, such as chemotherapy induced nausea and vomiting and AIDS wasting."

The IOM study also concluded that marijuana "does not appear to be a gateway drug...."

The co-chairman of the IOM committee who researched the medical use of marijuana was quoted in The New York Times as stating that the federal government "loves to ignore our report. They would rather it never happened."

HHS's failure to articulate a coherent position on medical marijuana supported by the scientific record leaves the Department vulnerable to legal challenge.

  • Click to read ASA Data Quality Petition
  • Click to read HHS' Third Letter Delaying A Decision of the ASA Petition
  • Click to read HHS Denial of the ASA Petition
  • Click to read ASA Appeal
  • Click to read HHS's Sixth Letter Delaying Decision on the ASA Appeal
  • Click to read FDA Inter-Agency Advisory
  • Click to read New York Times article on FDA Advisory
  • Click to read Americans for Safe Access website
  • Click to read Institute of Medicine study, "Marijuana and Medicine: Assessing the Science Base"