Bradley Merrill Thompson Mentioned in “Groundhog Day: FDA and Proposed Oversight of LDTs”Genomics Law Report January 22, 2015
Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was mentioned in Genomics Law Report, in “Groundhog Day: FDA and Proposed Oversight of LDTs,” by Jennifer K. Wagner.
Following is an excerpt:
One panelist, Bradley Merrill Thompson, attempted to lead the meeting’s attendees in a useful mental exercise to help identify the crux of the challenges involved with FDA oversight of LDTs. Thompson used hypothetical scenarios to ask a series of questions designed to identify underlying factors relevant to identifying the legal line between the provision of professional medical services and the the manufacturing of pharmaceuticals—in other words, when does the LDT become an in vitro diagnostic (IVD) that is unquestionably subject to oversight by the FDA? Unfortunately, the exercise was disrupted by a disgruntled audience member and left unfinished as the session moderator had the panel move forward. Thompson subsequently published his exercise and accompanying thoughts online; he noted that both sides in the authority debate may be overlooking limitations in their arguments and concluded that some LDTs are outside the scope of the FDA’s reach and the legal distinction is not as simple as identifying the actor (i.e., laboratorians versus manufacturers).
This article also mentions Mr. Thompson’s blog post “The LDT Debate: Understanding FDA’s Jurisdiction Over IVDs Made at a Clinical Lab” on the firm’s Pharma MedTech Insights blog.