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  • Washington Highlights

    Alexander Announces “Step by Step” Committee Consideration of Biomedical Innovation Bills

    Tannaz Rasouli, Sr. Director, Public Policy & Strategic Outreach

    Senate Health, Education, Labor and Pensions (HELP) Committee Chair Lamar Alexander (R-Tenn.) Jan. 19 announced the committee will hold the first of three executive sessions on Feb. 9 to consider a series of at least seven bipartisan bills on biomedical innovation.

    The committee also will meet in March and April to consider additional bills.

    “Senators and staff on our committee have been working together throughout 2015 to produce a number of bipartisan pieces of legislation that are ready for the full committee to consider,” said Chairman Alexander. “The House has completed its work on the 21st Century Cures Act. The president has announced his support for a precision medicine initiative and a cancer ‘moonshot.’ It is urgent that the Senate finish its work and turn into law these ideas that will help virtually every American.”

    Chairman Alexander had previously indicated the HELP Committee would consider a wide-ranging medical innovation bill similar to the 21st Century Cures Act (H.R. 6) passed by the house in July 2015 [see Washington Highlights, July 10, 2015].

    The bills slated for consideration at the Feb. 9 committee meeting include:

    • Bipartisan HELP Committee legislation to improve electronic health records;
    • The FDA Device Accountability Act of 2015 (S.1622), sponsored by Sens. Burr (R-N.C.) and Franken (D-Minn.);
    • The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S.2030), sponsored by Sens. Bennet (D-Colo.), Burr, Warren (D-Mass.), and Hatch (R-Utah);
    • The Advancing Research for Neurological Diseases Act of 2015 (S.849), sponsored by Sens. Isakson (R-Ga.) and Murphy (D-Conn.);
    • The Next Generation Researchers Act (S.2014), sponsored by Sens. Baldwin (D-Wis.) and Collins (R-Maine);
    • The Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (S. 800), sponsored by Sens. Kirk (R-Ill.), Bennet, Hatch, Murkowski (R-Alaska), Isakson, and Collins; and
    • Legislation regarding FDA regulation of duodenoscopes.

    The chairman continued, “The committee has also been working for months on legislation to help achieve interoperability of electronic health records for doctors, hospitals and their patients….” Chairman Alexander and Ranking Member Patty Murray (D-Wash.) Jan. 20 released a staff discussion draft to improve health information technology (see related story).

    Chairman Alexander also announced a second executive session on the innovation agenda expected March 9, when the committee will continue to consider bipartisan legislation to modernize the Food and Drug Administration and the National Institutes of Health (NIH) and provide congressional support for the president’s Precision Medicine Initiative. These bills will include:

    • The Advancing Hope Act of 2015 (S. 1878), sponsored by Sens. Casey (D-Pa.), Isakson, Brown (D-Ohio) and Kirk;
    • The Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101), sponsored by Sens. Bennet and Hatch;
    • The Medical Countermeasures Innovation Act of 2015 (S. 2055), sponsored by Sens. Burr, Casey, Isakson, and Roberts (R-Kan.);
    • The Combination Products Innovation Act of 2015 (S.1767), sponsored by Sens. Isakson, Casey, Roberts, and Donnelly (D-Ind.);
    • The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077), sponsored by Sens. Burr, Bennet, Hatch, and Donnelly; and
    • Legislation to support the president’s Precision Medicine Initiative and ensure that the NIH has the tools it needs to research treatments that are individualized for patients.

    A third and final markup is planned for April 6 to complete committee action on the innovation agenda.

    House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), the principal architects of the 21st Century Cures Bill, welcomed Chairman’s Alexander’s announcement.

    In a Jan. 19 statement, Upton and DeGette commented, “Momentum to deliver #CuresNow gets stronger by the day. We commend Senator Alexander and the committee for all of their work to boost medical innovation, and look forward to further collaborating in the weeks ahead. The Senate announcement is just the latest positive milestone in the effort to give patients and their loved ones more hope. But we have much work left to do to make 21st Century Cures a reality. The vice president is working on a ‘moon shot’ to cure cancer, and we’ve got a rocket ship ready to go.”