Laboratory, diagnostic manufacturer and pathologist trade lobbies are ramping up efforts to influence the agency proposal that is likely to explicitly define LDTs as medical devices.
The potential change would likely subject some of the tests, which are created and used within a single laboratory, to FDA review. Some groups argue that FDA evaluation would hinder innovation and rapid deployment of tests, while others say more oversight would protect patients and ensure that important tests perform well clinically.
The White House Office of Information and Regulatory Affairs, which does the final review of regulations before they are formally published in the Federal Register, recently met or is scheduled to meet with several groups in the coming week.
They include the Association for Molecular Pathology, American Clinical Laboratory Association, Advanced Medical Technology Association, Friends of Cancer Research and a group that included the Center for Science in the Public Interest.
Historically, the FDA exercised enforcement discretion for LDTs, but in recent years regulators have become concerned as the tests are being created for more complicated uses, such as genetic testing to predict how well a person will respond to specific medications.
Friends of Cancer Research CEO Jeff Allen told POLITICO it is important that there is FDA tracking if an LDT is significantly different or underperforming compared with another test or diagnostic.
“There’s just essentially a blind spot around the performance of certain tests, because [labs are] not necessarily required to share this information,” Allen said.
Legal controversy: During the Covid-19 pandemic, HHS general counsel Robert Charrow in the Trump administration wrote a memo contending that the FDA’s position that LDTs are medical devices contained several weaknesses, such as a lack of notice-and-comment rulemaking.
But FDA officials, including Center for Devices and Radiological Health Director Jeff Shuren, maintain that the agency has the authority to regulate LDTs. FDA Commissioner Robert Califf hinted last year that the agency would move to issue new regulations if Congress did not pass legislation to craft a new regulatory framework for the tests.
Background: Congress considered adding bipartisan legislation to the latest FDA user fee reauthorization that would have overhauled how LDTs and diagnostics are regulated, but the legislation failed after opposition from academic medical centers and other groups.
The bill, the Verifying Accurate Leading-edge IVCT Development Act, would have established a tiered structure where high-risk tests would be subject to premarket review and low-risk tests would be exempt from review.
What’s next: The Biden administration’s spring 2023 Unified Agenda targeted a release of the LDT proposed rule by the end of August.