Data Act Faces New Test as Drug Group Speeds Up Lawsuit Plans

April 27, 2006

, Inside EPA

Attorneys for a medical marijuana advocacy group are speeding up their plans to file a new lawsuit under the Information Quality Act (IQA), which supporters of the law hope could set a new precedent allowing outside groups to sue EPA and other agencies over their delays in correcting allegedly flawed data.

The lawsuit would be the first under the IQA since a federal appeals court earlier this year threw out the first major test case under the statute, saying the act does not allow outside parties to sue the government over its final decisions. The act allows the public to petition the government to correct flawed federally disseminated data.

Environmentalists and other public interest groups are strongly opposed to the IQA and say that if judicial review were provided, industry groups critical of new regulations could bog down federal rules by challenging selected data in court. But industry groups, who say the law is a crucial tool to correct poor data, argue that Congress intended to provide judicial review even though the law is silent on the issue.

The Americans for Safe Access, a California-based medical marijuana advocacy group, says it may file a new IQA lawsuit against the Department of Health & Human Services (HHS) as soon as next week because the department has failed to act on a long-standing petition the group filed challenging claims on the health benefits of using the drug.

The group says it has sped up its plans because of two recent contradictory statements by HHS on the potential health benefits of the drug, which a source with group says will help establish that the government is acting in an "arbitrary and capricious" manner in continuing to delay a final decision on the petition. The suit, which may be filed May 2 in a federal district court in California, would be the first to test whether the IQA allows judicial review for government inaction.

Earlier this month, HHS issued its sixth delay of the group's petition to correct the department's data, which says "marijuana has no currently accepted medical use in treatment in the United States." HHS said in an April 12 letter to the group that more time was needed to "coordinate" the government's final position on the issue.

But last week, the Food & Drug Administration (FDA), which is overseen by HHS, issued a statement in response to a host of congressional inquiries on the government's views on whether there is scientific evidence to support medical marijuana use. FDA's April 20 advisory said a host of HHS groups have studied the issue and concluded, "No sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." The advisory adds, "FDA has not approved smoked marijuana for any condition or disease indication."

HHS officials did not respond to calls for comment.

The Center for Regulatory Effectiveness (CRE), an industry-funded watchdog group and a leading proponent of the IQA, says the government is not issuing a final decision because Americans for Safe Access is likely to sue if the government rejects its petition. A source with the CRE says HHS' continuing delays may indicate that federal officials fear they may lose on the merits of such a case, which would mean that a federal court could for the first time establish that all decisions under the act are judicially reviewable.

But before a final HHS decision is made, the source believes the medical marijuana group has a strong chance of establishing that the act provides judicial review to compel agency action because of HHS' seemingly contradictory actions. The CRE is advising the medical marijuana advocates in their planned suit.

Despite the facts, some administrative law experts have said compelling federal action is difficult because courts often recognize that agencies are strapped for resources and hard-pressed for time, and meeting deadlines on IQA petitions is not possible in light of other priorities (Inside EPA, Dec. 2, 2005, p1). Also, the government often settles with plaintiffs and sets a deadline for a final decision, so the court may never rule to compel agency action.

Nevertheless, the medical marijuana suit will likely be closely monitored because it will be the first litigation since the March 6 ruling in Salt Institute and U.S. Chamber of Commerce v. Michael Leavitt, where the U.S. Court of Appeals for the 4th Circuit affirmed a lower court ruling that the plaintiffs lacked standing to sue under the IQA. As part of its IQA request for HHS to correct data on the health effects of salt intake, the Salt Institute wanted the government to make publicly available all information that supported its findings (Inside EPA, March 10, p1).

But the government refused to provide the information, and interpreted the industry's petition as a request for data under the Freedom of Information Act (FOIA). Both the lower court and 4th Circuit agreed with the government, with the 4th Circuit saying the plaintiffs did not have a right to the data under FOIA.

Sources on both sides of the act have agreed that the case may not have been the best test of the IQA's judicial review limits because of the FOIA issue.

 

 



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