FDA Crackdown on Labs

The US Food and Drug Administration (FDA) has announced its intentions to regulate laboratory developed tests (LDTs). The agency has had the authority to regulate LDTs since 1976, but until now has refrained from doing so (1). US laboratories have instead been regulated by the Centers for Medicare and Medicaid Services (CMS) using Clinical Laboratory Improvement Amendments (CLIA), which have been in place since 1988.

So why is the FDA stepping in now? It cites the increasing complexity of LDTs, and their roles in critical decision making – in particular relating to personalized medicine.

The agency intends to take a “risk-based” approach (similar to the model it currently uses for assessing medical devices); LDTs considered high risk will be brought under the new regulations, while risk tests and tests for rare diseases, which do not have an FDA-approved equivalent, may not require no further guidelines (1).

Although some organizations have come forward to express their support for the new regulations, such as the American Association for Cancer Research, others aren’t so pleased by the proposed changes. The American Medical Association (AMA), the American Clinical Laboratory Association (ACLA), and the Association for Molecular Pathology (AMP) have all met the proposed regulations with some skepticism, pointing to the regulations and accreditation procedures already in place. They also voiced concerns that further regulations could lead to the loss of patient access to required tests, increased cost of testing, and stifled innovation in the laboratory.