FDA proposes a new layer of regulation for laboratory developed tests

The Food and Drug Administration (FDA) announced its intention to expand the regulation of laboratory developed tests (LDTs). LDTs identify patients’ individual reactions to pharmaceutical treatments, so medical providers can prescribe the best treatment for the particular patient. Unlike medical devices from traditional manufacturers, LDTs are designed, manufactured, and used within a single laboratory. On July 31, 2014, the FDA notified Congress of the agency’s potential framework for regulating LDTs. Review the FDA’s description of the framework’s anticipated details to Congress here.

The FDA heralded the expanded regulatory framework as a commitment to personalized medicine. The FDA’s hope is that laboratories will identify the need for LDTs early in the drug development process. Early evaluation allows the drug and its companion test to be developed at the same time.

The FDA proposes to regulate LDTs based on the existing medical device classification system. High-risk LDTs will be subject to registration and listing (or notification), adverse event reporting six months after the guidance is finalized, and premarket review requirements twelve months after the guidance is finalized. Moderate-risk LDTs will be subject to registration and listing (or notification), and premarket review requirements five years after the guidance is finalized. LDTs that are traditional, low-risk, for rare diseases, or for unmet needs will be subject to registration and listing (or notification) and adverse event reporting.

One major issue with the FDA’s expanded role is that LDTs are already subject to other regulation. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires clinical laboratories to conduct laboratory tests and report them to the Centers for Medicare & Medicaid Services. Critics of the FDA’s expanded regulatory role argue that imposing two levels of regulation will stifle innovation, thereby limiting patient access to effective treatment. If the FDA’s framework is finalized, laboratories will have to send different reports to the FDA and the Centers for Medicare & Medicaid Services. Expanding CLIA instead could have improved the safety of personalized medicine without creating multiple layers of regulation.

Proponents of the FDA’s expanded role in LDTs argue that high-risk diagnostic tests should be regulated the same, regardless of whether created by traditional manufacturers or single laboratories. The new framework imposes regulatory requirements on LDTs like the requirements for medical devices from traditional manufacturers. The FDA’s stance is that the current regulatory framework fails to properly address the safety and effectiveness of LDTs.

The FDA plans for an upcoming 90-day public comment period after it releases its draft guidance. The FDA will host a public meeting during the comment period. The agency will publish notices for both the comment period and the meeting in the Federal Register.

After the FDA releases its draft guidance, we will post a link to both the draft guidance and the comment form on this blog.