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AMP releases statement on diagnostics in drug labels
Date:5/16/2011

White Oak, MDMay 16, 2011 Today, the Association for Molecular Pathology (AMP) released its new position statement on the appropriate manner to reference diagnostic tests in drug labels. The association also met with officials from the United States Food and Drug Administration that participate in the effort to draft guidance documents for co-developed products and companion diagnostics to inform them of its new position statement.

With advances in genomic medicine, providers can use targeted therapy to tailor dosing, improve drug response, and to avoid adverse events. Pharmaceutical manufacturers control the label's content and can choose to describe a laboratory test by its molecular description or by its brand name. The latter limits pathologists from choosing the test that best suits the needs of their patients, physicians and laboratory environment. And rather than consulting with the molecular pathologist to consider all relevant information from the patient's medical history, together with the most effective laboratory testing strategy at the least cost, treating physicians such as oncologists may reflexively order the test listed in the labeling. Therefore, referencing diagnostic tests by their brand names in drug labeling may create a situation where patients are not receiving optimal care.

"When the FDA approves a label that includes a brand name of a diagnostic kit, the medical community often views this as a tacit endorsement of that one company's test," explained AMP Professional Relations Committee Chair Dr. Elaine Lyon, "Indeed, diagnostic companies' marketing strategies might exploit this view."

Because healthcare providers may request testing using the test identified in the drug labeling, and payers may only reimburse if that specific test is used, laboratories will be put in the challenging position of having to purchase and verify multiple test kits for the same analyte. In addition, if a diagnostic company was t
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Contact: Mary Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

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