Pathways’ Pick of the Week: Lawmaker Challenges FDA on HVAD Handling

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Illinois representative Raja Krishnamoorthi criticizes FDA’s handling of HVAD safety problems. Excerpted from Pathways’ Picks March 30, 2022

FDA should have taken stronger and quicker enforcement action to address safety problems with the HeartWare HVAD ventricular assist device, and notified CMS and other agencies of the issues much sooner, Rep. Raja Krishnamoorthi (D-IL) charged in a letter to Commissioner Robert Califf. Medtronic plc suspended sales of the HVAD device last year, ceding the market to Abbott Laboratories Inc.’s HeartMate systems, after more than a dozen Class I recalls over seven years. Rep. Krishnamoorthi, who chairs a subcommittee of the House Committee on Oversight and Reform, pointed to a 2014 warning letter (prior to Medtronic’s 2016 acquisition of Heartware International and its technology) and a 2018 inspection as providing ample evidence that more action was needed. “FDA failed to seize devices, stop HeartWare from selling them, or assess monetary penalties against HeartWare after the 2014 violations and despite continuing violations,” the lawmaker writes. He gives FDA until April 5 to respond to questions about its efforts to address HVAD safety issues since 2014. The letter also raises scrutiny of FDA’s device safety authorities just as Congress is getting ready to reauthorize device user fees. (See “Device Safety Reforms: What’s in the Conversation?” Market Pathways, February 21, 2022.)

Excerpted from “Pathways’ Picks March 30: Hill Action, Budget News, Personnel Picks, and More,” Market Pathways, March 30, 2022.

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