Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, provided commentary in an article titled “Examining IVD-Related Election Year Issues.”
Following is an excerpt:
Thompson said: I will personally be following the Congressional focus on changes to the FDA regulatory approach for diagnostics, as well as Medicare payment changes that might impact those products. Right now, there are a lot of good ideas being batted around on Capitol Hill and in the IVD industry. They each take a somewhat different approach to the same basic problem: delays associated with introducing important new diagnostics into the marketplace, and the irrational differences in the regulatory schemes that apply to diagnostics developed by IVD manufacturers and laboratories?….