The Senate Health, Education, Labor and Pensions Committee will consider a group of biomedical reform bills, including device regulatory proposals, at three hearings from February through April, Committee Chairman Lamar Alexander, R-Tenn., announced Feb. 19.

Similar to the 21st Century Cures legislation passed in the House this summer, most of the Senate bills are focused on accelerating the product development and approval process for drugs and devices. (See Also see "'Cures' Bill Passes, As More Budget, Safety Debates Wait In The Wings" - Medtech Insight, 10 July, 2015..) But at least one device measure is focused on product safety: soon-to-be introduced legislation linked to the regulation of duodenoscopes. HELP Committee Ranking Member Patty Murray, D-Wash., is the likely sponsor of the bill; she issued a report earlier this month highlighting shortcomings in how infection outbreaks linked to duodenoscopes were handled by manufacturers and FDA. (See Also see "Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms" - Medtech Insight, 14 January, 2016..)

Other device bills that will get attention are the previously introduced FDA Device Accountability Act and the Advancing Breakthrough Medical Devices for Patients Act, each of which match provisions in the House Cures legislation, and the Combination Products Innovation Act. (See table below.) But it is not clear that Chairman Alexander is putting together a comprehensive package to match the House Cures bill.

There will be one hearing each in February and March to consider specific bills. Alexander indicated that a third and final markup is planned for April 6 to complete committee action on its innovation agenda.

Senate HELP Panel Schedule For Device-Related Medical Innovation Bills

Bill or Proposal	Sponsor(s)	Hearing Date	Purpose
Discussion draft legislation on electronic health records released Jan. 20.	Bipartisan; Sens. Lamar Alexander, R-Tenn., and Patty Murray, D-Wash.	Feb. 9, 2016	Goal is to reduce physician documentation, and stop information blocking so that de-identified medical records can be used to monitor health outcomes for large populations and integrate with registry data. It would be useful for clinical trial design.
The FDA Device Accountability Act/ S.1622	Sens. Richard Burr, D-N.C., and Al Franken, D-Minn.	Feb. 9, 2016	Seeks to strengthen “least burdensome” requirements at FDA, so that reviewers of new product do not ask for more data than necessary for premarket review. Also, it would allow centralized institutional review boards for device trials and would mandate FDA refine its approach to assessing diagnostics that can be waived for use in simpler lab environments. (See Also see "Senate Bill Tackles 'Least Burdensome,' Centralized IRBs, CLIA Waivers" - Medtech Insight, 18 June, 2015..)
Legislation on FDA regulation of duodenoscopes	Ranking member Patty Murray is expected sponsor.	Feb. 9, 2016	In her recent “Preventable Tragedies” report , Murray called for phased-in recalls of flawed duodenoscopes; for UDIs to be included in medical claim forms; and for clarification on when modified devices require new 510(k)s. (See Also see "Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms" - Medtech Insight, 14 January, 2016..)
The Combination Products Innovation Act/ S.1767	Sens. Johnny Isakson, R-Ga., Bob Casey, D-Pa., Pat Roberts, R-Kansas, and Joe Donnelly, D-Ind.	March 9, 2016	Would streamline combination product registrations by letting the agency rely on prior PMAs and approved drug findings to help support new product approvals, among other reforms. (See Also see "Senate Bill Aimed At Streamlining Combo Product Regulation" - Medtech Insight, 20 July, 2015..)
The Advancing Breakthrough Medical Devices Act/ S.1077	Sens. Burr, Michael Bennett, D-Colo., Orrin Hatch, R-Utah, and Donnelly.	March 9, 2016	Calls for an expedited FDA pathway for review of breakthrough medical devices.
Legislation to support the president’s Precision Medicine Initiative	No sponsor yet.	March 9, 2016	Text not available.

Senate Will Tackle Separate Device Reform Bills As Part Of Innovation Agenda

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