Dx Debate, Medicare Diabetes Endpoints, EU Expert Panels, and Global Picks

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In this week’s Pathways Picks: Congress faces lab-developed test conundrum; FDA retries device ban; CMS works on diabetes device endpoints guidance; selective EU device expert panels; HTA guidelines; Brazil adds to MDSAP benefits; Kenya, Jordan, and Mexico join IMDRF, and more from the US, UK, and China.

FDA Picks

Diagnostics on the Hill, Breakthroughs on the rise?:

The never-ending Dx regulation debate continues. As FDA gets ready to finalize its regulation of laboratory developed tests (LDTs), a critical mass of Republicans and Democrats threw their support behind legislation to supplant the agency’s pending rule during a March 21 House hearing. But it wasn’t clear that lawmakers are any closer to resolving disagreements on details that blocked passage of such a bill—the bipartisan VALID Act, which would comprehensively reform FDA diagnostics regulations —in 2022 and in several prior attempts. We have had multiple hearings on this over the last 20 years, and I bet this is not the last one,” said Rep. Michael Burgess (R-TX).

Republicans convened the hearing to register their opposition to FDA’s pending final rule to phase-in risk-based premarket review of LDTs, which have historically not been subject to FDA oversight. AdvaMedDx testified at the hearing, reiterating test kit makers’ support for FDA’s rule but a strong preference for the broader IVD reforms envisioned by the VALID Act. Lab representatives at the hearing, meanwhile, underscored their strong opposition to FDA’s rule and their measured support for some version of VALID. However, a representative for an academic pathologist alliance said her cohort continues to oppose both the FDA rule and the VALID Act or any other effort to establish FDA oversight of LDTs.  

Democrats argued during the hearing that FDA’s rulemaking efforts are unavoidable unless Congress gets its act together. “This is the sixth year for Congress to be grappling with the VALID act, so we have not acted validly,” said Anna Eshoo (D-CA). “We have to accept that. … The lack of action has really forced FDA’s hand to come up with their proposal.”


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