FDA Delay of RX Pot Petition May be Ploy to Put Off DQA Case

April 20, 2006

, FDA Week

HHS for the sixth time has postponed deciding on a medical marijuana petition under the Data Quality Act, according to the department’s Web site. The string of 60-day delays may mean that the government fears the DQA is judicially reviewable, according to a group that supports a policy of judicial review under the data quality law. Industry observers say possible future court action on the medical marijuana issue could set a judicial precedent on the DQA’s legal scope.

 

An ASA spokesperson says the group will wait until fall before trying to get the courts to force a decision under the Administrative Procedures Act. The source says judges have a lot of discretion under the APA so waiting for further delays will help the group’s case. If HHS is forced to decide and it denies ASA’s request, the group will ask a court to review the denial under the DQA.

 

The DQA, sometimes called the Information Quality Act, requires that federal agencies justify regulatory decisions with scientific data. If the government disseminates information that a group believes violates the law, the group may petition the government for a correction. However, Congress did not clearly state if courts could review agency decisions, and the Center for Regulatory Effectiveness, which lobbied for the DQA, have been lobbying for judicial review.

 

A U.S. appeals court recently refused to review an HHS decision on a DQA petition by the salt industry. But CRE says that was a poor case, and hopes the medical pot case will make its way to the courts (see FDA Week, March 30). The CRE is not involved with the ASA petition.

 

Bruce Levinson of the CRE interprets HHS’ delay to mean that FDA believes marijuana has the potential for medical use, and HHS fears the courts could review their decision.

 

“If the agency believed that marijuana did not have medical value, they could have rejected the petition and provided their rationale,” Levinson states in an e-mail. “If the FDA thought that the 4th Circuit case was definitive, they could dismiss the petition without any concern of court action. My only conclusion is that the 6th extension reflects FDA unease with both their own formal position on the medical value of marijuana and with their legal position should the issue go to court.”

 

Americans for Safe Access, which supports medical marijuana, petitioned HHS in October 2004 under the DQA to correct what it argues are misstatements that marijuana and its constituent compounds have no medical use.

 

“Specifically, in 2001, HHS issued statements in its review of the Marijuana Rescheduling Petition of 1995 that violate both government- wide data quality standards and the HHS guidelines implementing those standards,” ASA writes in the original petition. “The conclusion of HHS that ‘marijuana has no currently accepted medical use in treatment in the United States’ lacks objectivity, utility, transparency, peer review, and public participation. Thus, HHS has failed to ensure that the information it disseminates is based on sound science, as required by [the DQA].”

 

After some back and forth, HHS April 2005 said it was not acting on ASA’s request. Instead, HHS said it would consider the request in connection with a petition to reschedule marijuana, which has been pending since 2002. ASA appealed a month later. Since then, HHS has delayed answering six times.



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