|
 |
DATA ACT FACES NEW TEST AS DRUG GROUP SPEEDS
UP LAWSUIT PLANS
_______________________________________________
Date: April 28, 2006 -
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.
Source: Inside EPA via InsideEPA.com
Date: April 28, 2006
Issue: Vol. 27, No. 17
©
Inside Washington Publishers
INSIDEEPA-27-17-18