Sen. Kane Seeks Congressional Help For Seymour Clinical Research Company

March 4, 2009

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.