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Bloomberg Law — FDA Moves to Cement Diagnostic Test Oversight With Proposed Rule

Bloomberg Law — FDA Moves to Cement Diagnostic Test Oversight With Proposed Rule

  • Fulfills agency promise after bill failed to pass last year
  • Move faces opposition from lab groups, academic centers

The FDA would have clear authority to regulate medical tests that come from a single laboratory under a proposal released by the agency Friday.

The proposed rule (RIN: 0910-AI85) marks a pivotal step in the Food and Drug Administration’s mission to settle a longstanding debate over how much oversight the agency has on laboratory developed tests (LDTs) used to detect diseases, conditions, and infections.

The FDA’s proposal would explicitly label LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, and would allow the agency to regulate these products the same way it has historically regulated commercial diagnostics. The FDA had promised to move forward with rulemaking on LDTs after Congress failed to include provisions in a year-end spending bill that would have clarified the FDA’s authority over these products.

The FDA has since the 1970s adopted a policy of not taking direct enforcement action on LDTs. Given the growing complexity and volume of these tests, “this approach no longer makes sense and puts US patients at risk,” FDA Commissioner Robert M. Califf said in a call with reporters.
“This leaves Americans vulnerable to making important healthcare choices based on potentially faulty or inaccurate test results,” Califf said.

The proposal’s release comes ahead of a potential government shutdown, which appears increasingly likely as lawmakers struggle to reach a funding deal before a Saturday evening deadline. Under a shutdown, the FDA would have to pause any policy work not deemed essential and not covered by industry user fees.

The agency has long maintained it can regulate LDTs in the same way as commercial diagnostics. But efforts to make this explicit in federal law have repeatedly drawn resistance from lab groups and academic medical centers that argue they’re already regulated by laboratory requirements of the Centers for Medicare & Medicaid Services.


Proposal Sees Pushback

The American Clinical Laboratory Association pushed back on the FDA’s proposed rule, arguing the agency “does not have statutory authority to regulate LDTs under its medical device authority.”
“Any expansion of FDA’s role in this framework should be tailored by Congress to fit LDTs, just as has been done for food, supplements, drugs, and cosmetics—each of which has a distinct framework suited to the unique characteristics of its category,” the group said in a statement.

The agency is accepting comments on the proposal for 60 days, and is asking stakeholders to submit feedback on areas such as whether the agency should continue exercising enforcement discretion on pre- market review quality system requirements for any tests currently on the market.

The FDA is also seeking comments on “a tailored approach for LDTs made by academic medical center laboratories and applying a longer phase-out period for smaller laboratories,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said during Friday’s call.

The FDA confirmed its intention to move forward with a proposed rule in June when the draft item appeared in the unified agenda, a biannual publication of the US government’s expected regulatory actions.

Legislative Framework

Despite its continued defense of its ability to oversee LDTs, the FDA has long opted to pursue changes through legislative action to get all stakeholders on board. But Califf first hinted at the possibility of rulemaking last fall as Congress’s ability to pass legislation on LDTs by the end of year came into question.

In March of this year, Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) reintroduced the VALID Act (H.R. 2369). The bill, which the FDA has long supported and for which it provided technical assistance, would create a new medical product category for in vitro clinical tests and then calibrate the level of FDA oversight so it would be commensurate to the risk level of the device.

Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the FDA’s Center for Devices and Radiological Health, said in June that the regulatory framework proposed under the VALID Act would fall more in line with the standards used for tests in other countries.

Shuren said Friday the FDA remains open to working with Congress on this legislation, but added “our concerns have grown in recent years, and so we are moving forward with rulemaking.”
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, or AdvaMed, said in a statement the group is still reviewing the FDA’s proposed rule, and continues “to urge Congress to adopt a modernized regulatory framework for diagnostics so that patients across the country have access to the best possible diagnostic test.”

The think tank and advocacy group Friends of Cancer Research has long supported the VALID Act. Jeff Allen, the group’s president and CEO, said Friday legislation could have provided additional flexibilites specifically tailored to LDTs that don’t currently exist within the FDA’s existing medical device pathways.
He added, though, that the organization is “pleased to see some movement” from the FDA. “Given the potential risks that exist from increasingly complicated tests here, we support doing something in order to ensure the accuracy of these tests that so many people rely on,” Allen said in an interview.