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
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
“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
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
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.