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Atlanta Business Chronicle Center
for Regulatory Effectiveness States that the FDA Tobacco Advisory Committee is
in Violation of the Federal Advisory Committee Act
PR Newswire WASHINGTON, Sept. 7 WASHINGTON, Sept. 7 /PRNewswire-USNewswire/ -- The Center for Regulatory
Effectiveness, a regulatory watchdog managed by former White House
Office of Management and Budget regulatory officials, has issued a scathing report
on FDA non-compliance with the Federal Advisory Committee Act (FACA). Central to CRE's arguments is the fact that FDA is dominating
the advisory committee by controlling the production of key studies. CRE has
called these illegal actions to the attention of FDA a number of times but FDA
continues to act outside the law because they conclude that since the product
in question is tobacco that the normal rules of fair play do not apply. On
September 27 FDA is to announce a Menthol
Subcommittee which will review scientific studies dealing with menthol. CRE has
expressed the concern that FDA will continue to work outside the law regarding
the operation of this subcommittee. More specifically, FDA will write the
report and submit it to the Menthol subcommittee for an up or down vote as it
did for the Constituents subcommittee —clearly using a group of outside scientists
as a ruse for its preconceived views on the science. HHS
has an office dedicated to the enforcement of FACA, why has it not acted?
Feel free to contact the Advisory Committee Oversight and Management
Staff (ACOMS), FDA at 301-796-8220 or the Center for Tobacco Products
240-276-1717 CRE
understands that elements of the tobacco industry were
supportive of FDA regulation of its
products; as the old saying goes: "you had better be
sure what you wish for – you may get it". TPSAC
is going to review every major regulation dealing with the tobacco industry for
years to come. It is essential that it begin its operations on a sound
footing, meaning compliance with FACA and the Data Quality Act – the
former a statutory mandate for fairness in its governance and the
latter a statutory mandate to utilize sound
science. See related articles including FDA
Week See an entire Interactive Public Docket
dedicated to the FDA Tobacco Advisory Committee. Express your views
here or at the end of this post. For additional information, call the Center for
Regulatory Effectiveness at 202.265.2383 or email Jim
Tozzi at tozzi@thecre.com SOURCE
Center for Regulatory Effectiveness |