Drugs

HELP Committee Plans 3 Hearings on Biomed/FDA Reform Bills

David McFarland

— 2 min read
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Senate Health, Education, Labor and Pensions (HELP) Committee chair Lamar Alexander (R-TN) says his committee will proceed with a “step-by-step” approach to move forward several bills on biomedical innovation. The approach is the Senate’s version of the 21st Century Cures Act that the House passed in July (see earlier story). The HELP committee will hold its first executive session considering at least seven bipartisan bills 2/9. Two committee meetings in March and April are also planned to consider additional bipartisan 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,” Alexander said in a statement. “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.”

Alexander 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—and the committee will be releasing a bipartisan staff draft of that legislation later this week for public comment.”

The bills presented for consideration 2/9 include:

  • Bipartisan HELP Committee legislation to improve electronic health records.
  • The FDA Device Accountability Act of 2015 (S.1622), sponsored by Sens. Richard Burr (R-NC) and Al Franken (D-MN)
  • The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S.2030), sponsored by Sens. Michael Bennet (D-CO), Burr, Elizabeth Warren (D-MA), and Orrin Hatch (R-UT)
  • The Advancing Research for Neurological Diseases Act of 2015 (S.849), sponsored by Sens. Johnny Isakson (R-GA) and Christopher Murphy (D-CT)
  • The Next Generation Researchers Act (S.2014), sponsored by Sens. Tammy Baldwin (D-WI) and Susan Collins (R-ME)
  • The Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (S. 800), sponsored by Sens. Mark Kirk (R-IL), Bennet, Hatch, Lisa Murkowski (R-AK), Isakson, and Collins
  • Legislation regarding FDA regulation of duodenoscopes.

Alexander said the second executive session 3/9 will continue to consider bipartisan legislation to modernize FDA and NIH and provide congressional support for the president’s precision medicine initiative, including:

  • The Advancing Hope Act of 2015 (S. 1878), sponsored by Sens. Robert Casey (D-PA), Isakson, Sherrod Brown (D-OH) 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 Pat Roberts (R-KS);
  • The Combination Products Innovation Act of 2015 (S.1767), sponsored by Sens. Isakson, Casey, Roberts and Joe Donnelly (D-IN)
  • The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077), sponsored by Sens. Burr, Bennet, Hatch and Donnelly
  • 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.

AdvaMed said in a statement: “The medical technology industry strongly supports the HELP committee's efforts to take a comprehensive approach to speeding the development and delivery of new medical advancements in the U.S... We are pleased that the mark-up schedule includes several pieces of legislation designed to improve the efficiency of FDA's medical technology review process and eliminate redundant regulatory obstacles, including provisions to:  expedite FDA approval of breakthrough medical technologies; improve the agency's review process for combination products; require FDA to take steps so that medical technology reviews are done in the most efficient and expeditious manner possible; allow device clinical trial sponsors to use a central Institutional Review Board to facilitate the conduct of multi-center trials; and improve the CLIA-waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients, among others.”

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