A bill by two progressive Congressional Democrats would provide the federal government with $75 billion to produce or purchase personal protective equipment (PPE) and medical devices to fight the COVID-19 pandemic. Sen. Bernie Sanders (I-Vt.) and Rep. Ro Khanna (D-Calif.) are co-sponsoring the bill, which aims to provide the money to the Federal Emergency Management […]
Senate Dems propose federalizing medical supply chain
Senate Democrats today introduced a bill that would put control of the nation’s medical supply chain in the hands of the federal government, using its expertise in military production and distribution to address the COVID-19 pandemic. The Medical Supply Delivery and Transparency Act would require the secretary of defense to appoint a civilian with experience […]
Senate committee favors Hahn for FDA chief
A Senate panel has recommended approval of Dr. Stephen Hahn as the new commissioner of the FDA. The U.S. Senate Committee on Health, Education, Labor & Pensions voted 18 to 5 to approve the nomination of Hahn, the chief medical officer at Houston’s M.D. Anderson Cancer Center. Hahn would replace acting commissioner Dr. Brett Giroir, […]
Senators question proposed device approval changes
U.S. Senators Patti Murray (D-Wash.) and Elizabeth Warren (D-Mass.) are challenging an FDA budget proposal that would ease the approval process for certain medical devices. In a June 24 letter to Acting Commissioner Dr. Ned Sharpless and Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, Murray and Warren target the “progressive […]
Medtronic: Infuse data delay was inadvertent
Medtronic (NYSE:MDT) reportedly said this week that its years-long delay in releasing adverse event data for its controversial Infuse bone-growth protein was inadvertent. The Minneapolis Star Tribune last month reported that a 2-year Medtronic review of some 3,647 Infuse patients in 2008 turned up about 1,000 adverse events that weren’t reported to the FDA until 2013. That prompted Sens. Al Franken […]
Senate bill would streamline FDA’s medical device reviews
A bipartisan duo in the U.S. Senate introduced a bill last week that aims to streamline the way the FDA reviews medical devices. Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) introduced S.2737, or “A bill to improve medical device innovation,” to the Upper Chamber’s Health, Education, Labor & Pensions committee March 17. Earlier this month the panel […]
Senators Warren, Grassley want more from CMS on UDIs
U.S. Senators Chuck Grassley of Iowa and Elizabeth Warren of Massachusetts are pushing for more unique device identifier integration on medical claim forms from U.S. healthcare agencies, with a focus on the Centers for Medicare and Medicaid Services. CMS was called out for expressing views on the system that are contradictory to those from the Department of […]
Senate panel advances FDA fast-track bill
A U.S. Senate panel yesterday advanced a bill that would create a fast-track program at the FDA for breakthrough medical devices. The Senate Health, Education, Labor & Pensions committee sent the bill, S. 1077 or “A bill to provide for expedited development of and priority review for breakthrough devices,” to the Senate floor. The bill, introduced last […]
US Senators urge FTC to probe Baxter, Braun & Hospira saline prices
Four U.S. Senators yesterday wrote the FTC urging a probe into possible illegal saline price inflation of 200-300% since a shortage of the fluid began in late 2013. The letter, sent to FTC chairwoman Edith Ramirez, was signed by Conn. dem senator Richard Blumenthal, Minn. dem Amy Klobuchar and Utah reps. Mike Lee and Orrin […]
Senate bill would allow Medicare patients to self-pay for med devices
A new U.S. bill introduced by 4 senators would allow Medicare patients to self-pay for medical devices not fully covered by Medicare without dealing with a series of administrative hurdles. The bill, titled the Accelerating Innovations in Medicine Act, was sponsored by Sens. Rob Portman (R-Ohio), Michael Bennet (D-Colo.), John Thune (R-S.D.), and Martin Heinrich […]
FDA panel on aneurysm devices | Regulatory news for the week of April 27, 2015
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