Stand Down on LDT Oversight Until Congress Acts: Attorney

Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA can resolve its “worst of all worlds” oversight of laboratory-developed tests (LDT) by standing down until Congress sets the authorized terms of the agency’s role in LDT oversight. Writing in his firm’s FDA Law Blog, Shapiro reviews the current situation on oversight of LDTs and raises concerns arising from an FDA 2019 Warning Letter to Inova Genomics.

He notes that although FDA claims that LDTs fall under its authority to regulate medical devices, the agency has never actively followed through on this assertion of authority. Thus, while FDA says that LDTs are subject to 510(k) clearance or PMA approval and post-marketing requirements, clinical laboratories make little effort to comply with the requirements. “If FDA’s position is accepted,” he declares, “then these clinical laboratories are massively violating the law every day. This state of affairs continues because FDA does not ‘generally’ enforce these requirements.”

Shapiro describes the current situation as “troubling,” saying that FDA considers LDTs to be important to the continued development of personalized medicine and yet believes that clinical laboratories are serious and persistent lawbreakers, “absolved only by the agency’s grace.”

The post reviews court cases that might apply in any effort to resist FDA selective enforcement of its oversight of LDTs, and finds the agency’s decision to suspend enforcement of the Federal Food, Drug, and Cosmetic Act (FFDCA) against the vast majority of clinical labs to be “constitutionally dubious.”

“No doubt,” Shapiro writes, “clinical laboratories enjoying the benefit of FDA’s so-called enforcement discretion will not object to being left alone (even if they do not agree that FDA is correct in its assertion of authority to potentially regulate them). But it is the suspension of the law against the many that makes it arbitrary to enforce it against the few.”

He concludes that all enforcement of the FFDCA against LDTs should end until Congress enacts an amendment to the FFDCA explicitly authorizing FDA to regulate LDTs and defining how it is to be done.