FDA targets more oversight of lab-made tests
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Tests for COVID-19, blood lead levels, breast cancer genes and other conditions could soon be held to higher accuracy standards under a much-anticipated plan from federal regulators.
The big picture: The Food and Drug Administration on Friday rolled out a plan to regulate lab-developed tests that have long escaped close agency scrutiny as Congress drags its feet on the issue. But the renewed effort to regulate so-called LDTs could face strong industry opposition.
Where it stands: Testing laboratories are regulated by the Centers for Medicare and Medicaid Services, but the agency doesn't evaluate the accuracy of a test, require adverse event reporting or provide protections to patients in clinical trials.
- Theranos, the disgraced blood testing company founded by Elizabeth Holmes, fell into the regulatory loophole and went to market without FDA review.
Catch up quick: FDA has become increasingly concerned about the quality of lab tests, the proposed rule says. FDA wants to treat tests made in laboratories like medical devices.
- FDA has said for years that regulating lab-developed tests falls within its authority, and the agency released a draft guidance on regulating tests in 2014. But after two years of strong pushback from industry, FDA pulled its proposal.
- Congress in 2018 started working on legislation to create a new regulatory framework for lab-developed tests under the FDA. The bipartisan bill is still held up in Congress and was cut from a big legislative package last year due to concerns over how it would affect academic medical centers that make their own tests.
- FDA said it would phase in LDT regulation over five years.
What they're saying: "FDA, is, I guess, sort of playing chicken [with Congress] by coming out with this rule and saying we're going to go ahead and regulate," said Jeffrey Shapiro, a partner at law firm King & Spalding who specializes in medical device law.
- Some have raised concern the FDA doesn't have the capacity to quickly review tests.
- "Unless FDA dramatically expands its workforce, they could easily become a bottleneck for important tests," Shapiro said. "Tests that are important for public health, especially newer and more innovative tests."
The lab testing industry opposes the proposal, and the American Clinical Laboratory Association said FDA regulation of lab tests should have to come through legislation.
Consumer advocates say the plan would ensure patients can rely on tests that, among other things, diagnose cancer and Alzheimer's disease.
- It would "close a gaping hole in FDA's current regulatory reach," Peter Lurie, president of Center for Science in the Public Interest and a former FDA official, said in a statement.
What's next: Expect legal action against the regulatory framework if FDA finalizes the proposal — and maybe even before then, Shapiro said.
