The lawsuit was filed in the United States District Court for the Northern District of California by Americans for Safe Access in response to a denial of an information quality challenge originally made against HHS and FDA in October 2004. The petition challenged various statements made by HHS and FDA in the Federal Register regarding the health benefits of marijuana. For instance, the Americans for Safe Access requested that the following statement, "There have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition," be revised to state, "Adequate and well-recognized studies show the efficacy of marijuana in the treatment of nausea, loss of appetite, pain and spasticity."
HHS denied the challenge, stating that it was in the process of performing a comprehensive review of the "peer reviewed literature in order to make a recommendation to the [Drug Enforcement Administration (DEA)] as to whether marijuana should continue to be controlled under the [Controlled Substances Act]." HHS also noted that DEA has a process to receive petitions from the public regarding the scheduling of a substance and that it is not the intent of DQA to create duplicative procedures for challenging the dissemination of government information. The Americans for Safe Access went on to appeal the decision, which was also denied by HHS.
DQA was attached to the Treasury and Government Appropriations Act and passed into law in late 2000. It is a two-paragraph section that slipped through Congress without debate and has grown into a mountain of controversy, often pitting industry against the public interest. DQA enables interested parties to challenge the use of data by government agencies and has often been used by industry to slow regulatory action and pressure agencies to remove or revise information on important matters of public health and safety.
Whether DQA supports judicial review has been a point of contention. Previous lawsuits to challenge agency decisions regarding data quality petitions have failed. In March 2006, the U.S. Court of Appeals for the Fourth Circuit dismissed a lawsuit brought by the Salt Institute and the U.S. Chamber of Commerce under DQA, when the court found that the act did not allow for judicial review and that the plaintiffs had not shown injury and thus lacked standing.
Though the current challenge is not made by industry and is not intended to slow regulatory action or restrict access to important government information, OMB Watch nevertheless has not supported the judicial reviewability of DQA decisions. First, DQA does not grant any unique right of action for litigation, as recent case law has shown. Second, enabling judicial review would provide another tool for industry to use against health, safety and environmental regulations. This seems highly inappropriate for a legal provision that has never been debated or reviewed by Congress.