Data Quality Act Case May have Broader Implications on FDA

In a case that may have wider implications for the data on which FDA bases its decisions, a medical marijuana rights group, Americans for Safe Access (ASA), has sued HHS and FDA for violating the requirements under the Data Quality Act, 44 U.S.C. § 3516 (the DQA).  The DQA, which was enacted in 2001, requires federal agencies to ensure and maximize the “quality, objectivity, utility, and integrity of information” disseminated to the public.  The information quality guidelines implemented by HHS requires that the agency ensure and maximize the “quality, objectivity, utility, and integrity of information” that it disseminates, as well as administrative mechanisms that allow affected persons to seek and obtain correction of information disseminated by HHS that does not comply with the guidelines. 

According to the ASA, since implementing its information quality guidelines under the DQA, HHS has stated that marijuana “has no currently accepted medical use in treatment in the United States.”  ASA alleges that this statement and the findings underlying it are inaccurate, and has identified numerous peer-reviewed scientific studies confirming the medical efficacy of marijuana, including a National Institute of Medicine report which was commissioned by the White House’s Office of National Drug Control Policy.  ASA complied with HHS’ administrative mechanisms and filed a petition and an appeal to correct what ASA believes to be erroneous statements.  According to the ASA, HHS’ responses were nonsubstantive and not timely. 

ASA filed suit in United States District Court for the Northern District of California on February 21, 2007.  ASA’s complaint requests, in part, that the court enjoin HHS and FDA from continuing to disseminate statements that marijuana “has no currently accepted medical use in treatment in the United States.”  If successful, this lawsuit may provide a precedent for challenging agency actions if the parties believe that the data on which the action is based is flawed, if the data is disseminated to the public.

By Christine P. Bump