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National Intelligence Report

Senate Bills Take Differing Tack on Genetic Test Oversight
April 9, 2007


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Sidebar: Legislative Outlook
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Clinical lab and pathology groups caution that added federal regulation could stifle innovations in molecular diagnostics that tailor treatment, drug therapies, and monitoring to patients with cancer, heart disease, diabetes, and other chronic conditions.

Sidebar: Legislative Outlook

The Kennedy and Obama bills have been referred to the HELP Committee, but there is a big concern among lab and pathology groups that the Kennedy bill could be "fast-tracked" by being attached to pending "must-pass" legislation reauthorizing FDA user fee programs for drugs and medical devices.

In a recent joint letter, 25 of these groups urged Kennedy to allow more time for hearings and other input on issues raised by his bill. And SACGHS has agreed to join the call for more time, said David Mongillo, ACLA vice president for policy and medical affairs, who spoke on the matter at the panel’s meeting held March 26-27. Also, during the ACLA audio conference, Hughes surmised that, at this point, it was not likely that the committee would rush to markup either bill during the FDA reauthorization process.

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