ARTICLE SUMMARY:
In this week’s Pathways Picks: Members of Congress push against FDA’s lab-developed test rule; Australia updates companion diagnostic resources; AI updates from Europe and the US; Guidance documents from US FDA and China NMPA; EPA rule; and more from Australia and the US.
Diagnostics Picks
Updates from the US and Australia:
US lawmakers push back on LDTs. FDA’s pending rule to regulate laboratory developed tests (LDTs) has sparked public action in recent days by Republican lawmakers who oppose the plan. Sen. Bill Cassidy (R-LA) issued a request for information from stakeholders March 13 seeking “ways to improve regulation of clinical tests in the US.” Cassidy is pursuing feedback on substantive issues and possible legislation by April 3, arguing that “recent efforts by the Food and Drug Administration to unilaterally pursue regulatory reforms through rulemaking go beyond its statutory authority and threaten patient access to timely care.” The next day, Reps. Cathy McMorris Rodgers (R-WA) and Brett Guthrie (R-KY) scheduled a hearing of the House Energy and Commerce Health Subcommittee, for March 21, to address diagnostics test regulations. The session will include testimony from AdvaMedDx Executive Director Zach Rothstein, American Clinical Laboratory Association President Susan Van Meter, and representatives from several other lab and health policy groups. “The FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input,” Rodgers and Guthrie charged. FDA published its proposed rule laying out a four-year transition to risk-based premarket review of LDTs last fall after Congress failed to pass comprehensive diagnostics reform legislation. The final rule is expected out by April or May.
