Bioethics Blogs

The FDA Proposes Roadblocks to Laboratory Diagnostics

The American laboratory industry and its ability to serve patients is being challenged by a Food and Drug Administration (FDA) proposal that will create a new bureaucracy to regulate some of the most important tests that labs perform.

On July 31, the FDA issued a 60-day notice that it planned to issue proposed guidance that would give the agency the authority to regulate clinical laboratory tests developed in certified and accredited clinical laboratories around the country. Laboratory developed tests (LDTs) are best-in-class diagnostics that are developed at individual labs. They are commonly used when there is no FDA-approved test or when a lab makes improvements over an existing kit. LDTs are not sold to other labs or to the public; they are only used by the lab that develops them.

Treating LDTs as medical devices will reduce access to life-saving tests. LDTs are currently regulated by the Center for Medicare and Medicaid Services (CMS) under the authority of the Clinical Laboratory Improvement Amendments (CLIA). Since its inception in 1987, CLIA has been very effective. The FDA, on the other hand, has no native expertise in the regulation of lab tests; it will need to create a massive and redundant bureaucracy to oversee these tests now regulated by CMS and through local and state regulations.  

The Scope of Bureaucratic Expansion

If issued, this authority would require that the thousands of highly complex clinical laboratories in the United States, most of which reside in hospitals, submit information to the FDA about hundreds of thousands of distinct tests.

The agency has not yet clearly explained how it will oversee all of these LDTs.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.