The Tests Are Vital. But US Congress Decided That Regulation Is Not.
Anna Clark (ProPublica) 25 January 2023
This story was originally published by ProPublica.
 
A number of tests used by patients to make major health care decisions have once again escaped regulation by the Food and Drug Administration, following intensive lobbying on behalf of test-makers, professional associations and academic medical centers.
 
For years, experts have warned about the dangers of so-called laboratory-developed tests — including certain cancer screenings and diagnostic tests for everything from Lyme disease to autism — reaching patients without FDA oversight.
 
ProPublica recently published an investigation about popular prenatal screenings that fall into this category, which one expert described as an unregulated “Wild West.” Upwards of half of all pregnant people now receive one of these prenatal screenings. (We also have put together a guide for expecting parents.)
 
Congress was on the cusp of finally creating a pathway for the FDA to scrutinize these tests, as it does for many other common commercial tests. For much of 2022, the VALID Act seemed on track for passage — and then, in the final weeks of the year, legislators backed away.
 
The VALID Act, which had bipartisan support, had been developed after nearly a decade of debate among stakeholders about ways to close a regulatory loophole and clarify the FDA’s role in overseeing the testing industry. The legislation had momentum thanks, in part, to Theranos’ fraudulent blood-testing scandal and the coronavirus pandemic, both of which revealed the possible consequences of unchecked tests reaching patients.
 
But lawmakers left VALID out of a must-pass end-of-year bill that dealt with a range of spending priorities.
 
Opponents argued that VALID would have created burdensome regulations for lab-developed tests, or LDTs, stunting essential innovation and flexibility while limiting patient access to health care.
 
The current approach to lab-developed tests goes back to 1976, when Congress revamped the regulation of medical devices. At the time, the tests were considered low-risk and were not in wide use. Since then, the FDA has effectively exempted this type of lab test from its requirements.
 
Today, the number and complexity of lab-developed tests has grown. A study by the Pew Charitable Trust said there’s no way of knowing how many are used on patients each year because there are no tracking measures. But Pew estimated that 12,000 labs are likely to use LDTs, many of which process thousands of patient samples each day.
 
“The needs were getting bigger and bigger, and also the potential risks get bigger and bigger, too,” said Mark McClellan, who served as the head of both the FDA and the Centers for Medicare and Medicaid Services during President George W. Bush’s administration. He had urged Congress to pass the bill.
 
Several people involved in bill negotiations told ProPublica that concern over how it would affect academic labs is what killed it.
 
“University laboratories and their representatives in Washington put on a full-court press against this,” said Rep. Larry Bucshon, a Republican from Indiana. A former cardiothoracic surgeon, Bucshon co-sponsored VALID in the House, along with Rep. Diana DeGette, Democrat of Colorado.
 
Bucshon pointed to the Association of American Medical Colleges and the Association for Molecular Pathology as particularly influential forces that persuaded his colleagues to leave VALID out of the end-of-year bill.
 
According to disclosure forms, AAMC spent at least $300,000 on lobbying activities that included the VALID Act in 2022, while AMP spent at least $189,000. Since 2018, AMP spent at least $957,000 on lobbying activities that included VALID. Continue Reading
 
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