Company Threatened
By Creation Of New Tax Exempt Organization
Senator Rob Kane (R-32) has asked members of Connecticut’s
congressional delegation to help prevent a Seymour-based
clinical research company from becoming obsolete due
to the creation of a new non-profit clinical research
organization.
Senator Kane recently wrote to U.S. Senators Christopher
Dodd and Joseph Lieberman and U.S. Representative Rosa
DeLauro after visiting DOCRO, Inc., which specializes
in the design and conduct of clinical trials of in vitro
diagnostic products to gain marketing clearance or approval
from the U.S. Food and Drug Administration (FDA). In
his letter, Senator Kane said the continued existence
of the 12-year-old Seymour clinical research company
is threatened by the formation of a new tax exempt organization
being developed by the Critical Path Institute (C-Path),
an independent, nonprofit organization founded in Tucson,
Arizona in 2005 to bring “scientists from the
FDA, industry and academia together to improve the path
for innovative new drugs, diagnostic tests and devices
to reach patients in need.”
Senator Kane said that he is troubled that a local
taxpaying company could be put out of business by new
tax exempt organization created by a group, C-Path,
that was formed with the help of state and federal grant
money. He added that the new “United States Diagnostic
Standards” arm of C-Path would depend on funding
from the government and from mandated user fees paid
for by manufacturers of in vitro diagnostic products.
“Ultimately this entity will take the place of
efficient and experienced clinical diagnostic data test
sites such as DOCRO, eliminating the need for them and
effectively putting them out of business. Every service
that is being proposed to be done by C-Path’s
proposed United States Diagnostics Standards is already
being done at DOCRO with privately funded money and
without the use of grants. The C-Path alternative will
have to build from the bottom up using government money
to achieve something that already exists in a more streamlined
and efficient fashion at taxable businesses like DOCRO,”
Senator Kane wrote in his letter.
Senator Kane noted that DOCRO, which employs approximately
18 people, has earned a reputation for excellence in
diagnostic testing. He said that their success rate
at the FDA for in vitro diagnostic device approval or
clearance (a core area targeted by C-Path’s United
States Diagnostics Standards) is 99%.
“I urge you to help save DOCRO from becoming
obsolete. It would be a shame to lose this small business
in the State of Connecticut and to send their hard working,
accomplished staff into the ranks of the unemployed.
To that end, please do what you can from your position
as a member of our congressional delegation in respect
to the establishment of the United States Diagnostics
Standards captive audience initiative,” wrote
Senator Kane.
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