Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Inside Health Policy’sFDA Week, in “Attorney Points to Compounding Regs to Guide FDA in LDT Oversight,”by Erin Durkin.
Following is excerpt:
“In my opinion there is no legal issue [for FDA] to regulate IVDs, I am using that term carefully, [in vitro diagnostics] produced by laboratories,” said Bradley Merrill Thompson, an attorney at Epstein Becker & Green who discussed the topic on a panel. “There’s no question at all. The question is when does the LDT process merge into or become an IVD process regulatable by FDA. At the end of the day, there are legal issues distinguishing those two activities.”
Thompson said the LDT debate is similar to legal questions surrounding pharmacy compounding, where FDA set a line marking when pharmacists crossed over from pharmacy practice and began pharmaceutical manufacturing. In a draft blog he shared with FDA Week, the industry attorney refers to a compliance policy guide put forth by the agency in 1992 and 2002, but was declared obsolete when the Drug Quality and Security Act (DQSA) was passed in 2013.
“[T]he pharmacy compounding rules offer us guidance as to how we might approach the dividing line between legitimate laboratory services regulated by CLIA, and IVD manufacturing that FDA regulates, even if both are conducted in a clinical laboratory,” says Thompson.
