By Kimberly Scott, Managing Editor, G2 Intelligence
Final guidance on lab-developed tests being developed by the Food and Drug Administration (FDA) is likely to be delayed until after the fall elections, predicts a former FDA official.
Scott Gottlieb, M.D., resident fellow at the American Enterprise Institute and deputy commissioner of the FDA from 2005 to 2007, said that while in vitro diagnostic test manufacturers are pushing FDA to get the guidance out, there is not a great deal of urgency because “there’s not a lot of data that there have been problems in this space.” Gottlieb gave his prediction during the annual meeting of the American Clinical Laboratory Association, held April 23-24 in Washington, D.C.
The FDA in 2010 proposed to regulate LDTs under what it considered its “enforcement discretion.” The agency is currently working on guidance that will set up a regulatory framework for LDTs based on risk with exceptions for rare diseases, emerging biothreats, and emerging infectious diseases. The lab industry, however, is pushing for LDTs to be regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA). Legislation introduced by Rep. Michael Burgess (R-Texas) would set up a system within CLIA for LDT oversight. H.R. 3207, the Modernizing Laboratory Tests for Patients Act, would establish a notification and review process that would be paid for entirely through user fees paid by clinical laboratories seeking approval for LDTs.
In addition to setting up a regulatory framework, there are additional issues that FDA must grapple with in terms of LDT oversight, including staffing, possible use of a third-party for inspection of LDTs, and grandfathering of existing LDTs.