The comment period for the Food and Drug Administration’s latest power grab has just concluded. Roughly 20,000 comments were submitted addressing the FDA’s proposed rule which explicitly asserts its long-claimed authority to regulate laboratory-developed tests (LDTs) as medical devices. Many of these comments — including one from the Competitive Enterprise Institute where I am a senior fellow — and a Paragon Health Institute paper I wrote argue that the FDA lacks statutory authority to regulate LDTs, would be unwise to do so, and is ill equipped to undertake the task.
The Federal Food, Drug, and Cosmetic Act (FDCA) gives the FDA broad authority to regulate medical devices “intended for use in the diagnosis of disease.” The agency mandates a pre-market review of diagnostic test kits manufactured by one entity and sold for use elsewhere.
The FDA has also asserted for at least 30 years that this includes the authority to regulate LDTs — tests that are designed, manufactured, and used within a single laboratory — as devices. Many academic and public-health labs, for example, developed tests for rare genetic conditions seen in their patient populations, cancer markers, and emerging infectious diseases such as HIV when no other tests were available.
But until recently, the FDA, citing “enforcement discretion,” has rarely regulated LDTs. LDTs have instead been regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), under which laboratories that are certified to perform high-complexity testing — the highest of three levels of complexity under CLIA — may develop and use LDTs.
Read the full article on the National Review.