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Date: March 24, 2006
Industry’s hopes of using the
Information Quality Act to challenge in
court regulatory decisions were
dashed by a recent U.S. appeals court
ruling against the salt industry,
but sources say a likely medical
marijuana lawsuit could rehash the
debate over judicial review.
If a group challenging FDA’s
position against medical marijuana goes to
court, that lawsuit would be much
firmer and could lead to a
contradictory ruling, according to a
source at the Center for Regulatory
Effectiveness, which lobbied for the
IQA and supports judicial review of
agency decisions. The CRE is not
involved in the medical marijuana
petition.
IQA supporters, such as CRE, are
reeling from the appeals court ruling
against the Salt Institute, which
used the act to challenge HHS
statements that there is a link
between salt intake and high blood
pressure.
“By its terms, this statute [IQA]
creates no legal rights in any third
parties,” according to the ruling.
“Instead, it orders the Office of
Management and Budget to draft
guidelines concerning information quality
and specifies what those guidelines
should contain.”
“Because the statute upon which
appellants rely does not create a legal
right to access to information or to
correctness, appellants have not
alleged an invasion of a legal right
and, thus, have failed to establish
an injury in fact sufficient to
satisfy Article III.”
IQA supporters fear the ruling could
set a legal precedent against use
of the data quality act for judicial
review. “On one hand, it is
unquestionably a blow,” to the IQA,
says CRE’s Bruce Levinson. “But it’s
not fatal.”
The data quality law 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.
The biggest question, and
controversy, over the IQA is whether it allows
judicial review of the data and
studies agencies use.
In Salt Institute, et al. v.
Leavitt, the U.S. Court of Appeals for the
4th Circuit court considered whether
industry could challenge in court a
dispute over a HHS rejection of an
IQA petition. HHS has stated that
reducing salt consumption lowers
blood pressure for everyone, and the
Salt Institute opposes that
statement.
Levinson said the salt industry suit
had a weak case.
“It was nonhelpful,” he said,
referring to the impact of the case as a
precedent.
The Salt Institute did not ask for a
correction, according to the
ruling, which is the point of the
IQA. Also, the Salt Institute could
not show any harm to industry, according
to Levinson, who said the data
that industry questioned is widely
supported by other studies.
“Because appellants’ lone request
was that information be made public,
NHLBI [National Heart Lung and Blood
Institute] construed their petition
for correction as a request for
information under the Freedom of
Information Act (FOIA) and denied
it,” the ruling states.
But the salt suit likely is not the
last word. The Americans for Safe
Access, who’s petition challenging
FDA’s position on medical marijuana
has been repeatedly delayed, plans
to eventually sue, according to a
spokesperson for the group.
Levinson said that case will likely
be much stronger.
ASA is asking for a specific
correction. Also, ASA can show harm because
patients are being deprived of a
drug that could help them in certain
cases, Levinson said.