Draft guidance from the Food and Drug Administration (FDA) of lab-developed tests appears to be stuck at the Office of Management and Budget and likely will not be released any time soon, according to a consultant who specializes in FDA regulation of medical diagnostics and tests.
Speaking at G2 Intelligence’s MDx NEXT conference in Baltimore June 12, Mya Thomae said she believes it’s unlikely that the draft guidance will ever be released, citing intense opposition by clinical laboratories. While manufacturers of in vitro diagnostic tests have called on FDA to “level the playing field” for IVDs and LDTs, Thomae said she does not believe there is the political will to push the document through. Even if it were to be issued, the FDA does not have the resources to regulate additional laboratory tests. Thomae is president and CEO of Myraqa Inc., a regulatory consulting firm in Redwood Shores, Calif.
Regulation of LDTs by the FDA would present a whole new set of challenges for the industry as clinical utility is defined differently by the FDA than by the marketplace, explained Thomae. Most assays are used in the Clinical Laboratory Improvement Amendments (CLIA) environment long before making it to the FDA, if they ever do. The agency sometimes wants more clinical utility studies even when markers are in disease guidelines, she noted.
“CLIA enforcement discretion appears to be here to stay for the foreseeable future,” said Thomae. Ultimately, money may well dictate regulatory direction, said Thomae. “If reimbursement organizations require FDA clearance or approval of assays, then companies will obtain FDA clearance or approval,” she predicted. “If reimbursement organizations continue to remain ambivalent to FDA clearance or approval, then change is unlikely.”
The FDA has tried to place some restrictions on lab-developed tests through guidance documents issued Nov. 25, 2013, on research-use only (RUO) and investigational-use only (IUO) in vitro diagnostic products. The final guidance did omit the most controversial language included in the draft, which would have recommended that manufacturers of RUO- or IUO-labeled IVDs halt sales to lab customers they discover are using the products in clinical diagnosis.
Instead, the final guidance focuses on manufacturer statements and actions that would provide evidence of a clinical intended use for an RUO- or IUO-labeled IVD, including not only promotional labeling and advertising but also the “solicitation of business from clinical laboratories” by a manufacturer’s sales people who “make routine calls to clinical laboratories that do not perform research or clinical studies.” The guidance also encourages use of a “certification program” under which users certify that they will not use RUO or IUO products in a “manner inconsistent with the labeling.”
Takeaway: While the FDA wants to regulate lab-developed tests, extensive opposition by lab groups is helping keep LDT guidance from being finalized. Even so, the FDA is using other guidance documents as a way to restrict development of LDTs.
