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Coalition for 21st Century Medicine Issues Statement in Opposition of Genentech Petition to Restrict Lab Use of Diagnostic Tests for Physicians and Patients
Date:12/30/2008

s "a complex, lengthy process," Genentech requests that FDA punish companies before developing its regulations. The rights of laboratories to due process and fundamental fairness cannot be subordinated to a desire for haste.

Overturning the existing regulatory regime for LDTs would impose huge costs on laboratories. Even when a company possesses the data necessary to obtain FDA approval, companies still incur huge regulatory costs -- and delays -- in navigating the FDA approval process. Laboratories would incur significant additional costs to develop and implement systems that meet FDA's Good Manufacturing Practice regulations. Requiring FDA approval or clearance of every LDT used to make drug-related therapeutic decisions would cost the health care system a staggering amount of money. Nevertheless, Genentech's single paragraph on Economic Impact essentially ignores all of these direct economic costs, as well as all the health care costs that the health care system will bear because new LDTs will not be available. Genentech also entirely overlooks the costs to FDA of reviewing these submissions, and the impact on FDA's ability to handle its existing workload of diagnostic products.

The Coalition for 21st Century Medicine is committed to the development and dissemination of novel, scientifically robust and clinically useful diagnostic tests. Genentech's citizen petition requests the FDA to take actions that would preclude those objectives from being realized. We will be submitting to the docket a more detailed analysis explaining why the citizen petition should be rejected.

The Coalition for 21st Century Medicine represents some of the world's most innovative diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups -- all linked by a common mission to develop advanced diagnostics that improve the quality of healthcare for patients.'/>"/>

SOURCE The Coalition for 21st Century Medicine
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