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Another FDA Power Grab

Another Fda Power Grab
President at Paragon Health Institute
Brian Blase, Ph.D., is the President of Paragon Health Institute. Brian was Special Assistant to the President for Economic Policy at the White House’s National Economic Council (NEC) from 2017-2019, where he coordinated the development and execution of numerous health policies and advised the President, NEC director, and senior officials. After leaving the White House, Brian founded Blase Policy Strategies and serves as its CEO.

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.

The full article can be found in National Review.

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