Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, was quoted in an article about the impact of last November’s midterm elections on the IVD industry and IVD manufacturers.
Like most people, I expect gridlock for the most part. As a result, I do not foresee major healthcare changes coming out of this Congress. At the same time, there is the possibility for more focused, smaller scale improvements, and personalized medicine seems to attract a lot of interest on both sides of the aisle. The Hatch legislation (Better Patient Care Act of 2010) may get some attention, but I do not foresee it passing in its present form. That legislation seeks sweeping changes in the way FDA regulates IVDs, and it essentially throws the baby out with the bathwater in that it seeks a whole new approach that, frankly, is inconsistent with where the global regulatory community is headed. Right now, globalization means that international harmonization is quite important to the future of the IVD industry. At the same time, there are fundamental regulatory issues that need to be addressed such as FDA regulation of laboratory-developed tests, and the bill could provide a vehicle for doing so. So a modified version of the bill might stand a chance of being enacted.