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A powerful subcommittee says a new FDA proposal on medical testing will stifle innovation and may not be legal.
Three months ago we told you about laboratory-developed tests (LDTs)-inexpensive diagnostic tests for patients that are developed and performed by local labs. They include standard tests but also new ones, genetic tests, tests for rare conditions, and even custom diagnostics.
Tests like this are the future of medicine. People will soon be able to test for and spot cancers long before they manifest themselves using current methods. Testing can already help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases.
The new testing technology is a real hot potato for the FDA. Regulators are often suspicious of new products. The agency is also more influenced by older firms offering old technology. After all, it is the older and well-established firms that pay the FDA’s bills. Protecting them can also lead to lucrative jobs after leaving government. This is the old crony capitalist conundrum. It’s so easy for the foxes and those guarding the henhouse to make a deal.
Years ago, the agency developed a draft guidance to increase their control of LDTs, but it has been stalled in the Office of Management and Budget (OMB) since 2010. After pressure last May from the Combination Products Coalition (a lobby for the “drug, device, and biologics industries”), and more recently from five Senators, the FDA said it will finally release its draft guidance-which, according to those who have seen the guidance, would treat LDTs as medical devices, requiring premarket approval in some cases.
This has led others in Congress to accuse the FDA of overstepping its authority, with the House Energy and Commerce Health Subcommittee taking the lead. After our article was published, Rep. Michael C. Burgess (R-TX), the committee’s vice chair, said in a statement that the FDA’s regulatory approach to LDTs in this guidance “is redundant, will stifle innovation, and will require additional taxpayer funding for the FDA.”
On September 9, the subcommittee held a televised hearing on the regulation of LDTs at which the FDA, together with various industry, investor, and patient “stakeholders,” testified. The committee got to the heart of the matter when they grilled Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health: they questioned whether the agency even has the authority to regulate LDTs in the first place.