American Association for Clinical Chemistry
Better health through laboratory medicine
CLN Stat
By Bill Malone

Industry and lab groups have expressed support for several provisions wrapped up in legislation that sets the user fees paid to FDA by companies seeking approval of new drugs, tests, and medical devices. For example, the House version of the bill contains several measures meant to force FDA to show its hand on proposed laboratory-developed test (LDT) regulation. Under this bill, FDA would be required to notify Congress 60 days prior to issuing a guidance on the regulation of LDTs and allow the Department of Health and Human Services (HHS) to waive user fees for labs performing LDTs if and when FDA decides to step up regulation. FDA would also be required to include the anticipated details of any draft or final LDT guidance.

“We support this provision because any FDA guidance in this area would be a major change in policy, one that ACLA has serious concerns about,” said Mertz, president of the American Clinical Laboratory Association (ACLA). The Advanced Medical Technology Association (AdvaMed) also expressed support for the bill.

In addition to the provisions on LDTs, FDA would be required to speed up its reviews of tests and other medical devices, a process which has slowed in recent years. Other changes to FDA review in the legislation include an FDA report on its total time for reviewing devices, a requirement for greater interaction between sponsors and the agency, an independent appraisal of the device approval and clearance process, and an FDA corrective action plan to address deficiencies. In exchange, industry has agreed to pay $595 million in user fees for in fiscal years 2013-2017.

More information on the bill is available from the House Energy and Commerce Subcommittee website.


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Bill Malone 
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