Federal - HR 6

A bill to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.

Introduced

May 19, 2015

Description

A bill to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.

Our Position

Support

Original Sponsor 1

Co-Sponsors 230

Latest Actions See More/Less

  • Nov. 25, 2016Draft bill text released by

  • July 15, 2015Lofgren, D-Calif., House speech: Personal explanation for roll call vote no.433, and would have voted yea if present. Congressional Record p. E1072-E1073

  • July 15, 2015Lofgren, D-Calif., House speech: Personal explanation for roll call vote no.432, and would have voted yea if present. Congressional Record p. E1072-E1073

  • July 15, 2015Lofgren, D-Calif., House speech: Personal explanation for roll call vote no.431, and would have voted nay if present. Congressional Record p. E1072-E1073

  • July 15, 2015Lofgren, D-Calif., House speech: Personal explanation for roll call vote no.430, and would have voted nay if present. Congressional Record p. E1072-E1073

  • July 15, 2015Lofgren, D-Calif., House speech: Personal explanation for roll call vote no.429, and would have voted nay if present. Congressional Record p. E1072-E1073

  • July 13, 2015 — Received in the Senate and referred to the Senate Health, Education, Labor and Pensions Committee. Congressional Record p. S5005

  • July 10, 2015House Vote 433 Medical Funding and Authorization — Passage
    Passage of a bill that would modify current federal processes involving medical research, developing drugs and other treatments, and testing and approving those drugs and treatments in an effort to accelerate the development and delivery of cures to diseases and medical conditions. It would also reauthorize the National Institutes of Health (NIH) for three years and includes numerous initiatives to promote medical research and attract young scientists, and it reauthorizes Food and Drug Administration (FDA) activities for five years and modifies elements of FDA's drug and medical device review and approval process to accelerate the approval and distribution of new drugs and medical devices for diseases and conditions that don't currently have treatments. It would provide $9.3 billion in fully offset mandatory spending for a five-year "Innovation Fund" to provide additional funding to the two agencies, with NIH to receive $1.75 billion a year for biomedical research and the FDA to receive $110 million a year for Cures development activities. Passed 344-77. Congressional Record p. H5082

  • July 10, 2015 — Committee of the Whole amendments adopted by voice vote. Congressional Record p. H5082

  • July 10, 2015House Vote 432 Medical Funding and Authorization — Miscellaneous Policy Riders
    Lee, R-Calif., amendment that would strike language that applies any policy riders included in annual Labor-HHS-Education and Agriculture appropriations bills to National Institutes of Health (NIH) funds and Food and Drug Administration (FDA) funds provided by the bill. Rejected 176-245. Congressional Record p. H5072-H5074, H5081

  • July 10, 2015House Vote 431 Medical Funding and Authorization — Discretionary Appropriations
    Brat, R-Va., amendment that would change the mandatory funding for the new National Institute of Health and Cures Innovation Fund to an authorization of discretionary appropriations. Rejected 141-281. Congressional Record p. H5069-H5070, H5080-H5081

  • July 10, 2015 — Jackson Lee, D-Texas, amendment no. 8, to direct the Health and Human Services Department (HHS) to conduct outreach to historically black colleges and universities, Hispanic-serving institutions, Native American colleges and rural colleges to ensure that health professionals from underrepresented populations are aware of research opportunities that would be provided under the bill, adopted by voice vote. Amendment text. Congressional Record p. H5078-H5080

  • July 10, 2015 — Polis, D-Colo., amendment no. 7, to direct the Food and Drug Administration (FDA) to issue a report on the risks and benefits associated with a two-tiered approval process that would permit certain medical devices to provisionally come to market if they have demonstrated safety, but not efficacy, withdrawn by unanimous consent. Amendment text. Congressional Record p. H5077-H5078

  • July 10, 2015 — Fitzpatrick, R-Pa., amendment no. 6, to express the sense of Congress that recording unique device identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for post-market surveillance purposes, adopted by voice vote. Amendment text. Congressional Record p. H5076-H5077

  • July 10, 2015 — Slaughter, D-N.Y., amendment no. 5, to direct the Centers for Disease Control and Prevention (CDC) to conduct a study to determine how the additional payments under Medicare for the use of antimicrobial (DISARM) drugs are affecting the development of drug resistance, adopted to by voice vote. Amendment text. Congressional Record p. H5074-H5076

  • July 10, 2015 — Castro, D-Texas, amendment no. 4, to ensure that underrepresented individuals in the sciences, such as women and minorities, are included in a report on efforts to support emerging scientists, adopted by voice vote. Amendment text. Congressional Record p. H5074

  • July 10, 2015 — Young, R-Ind., amendment no. 2, to create authority within the National Institutes of Health (NIH) to conduct an Innovative Prizes Program to incentivize health innovation by offering competitors the chance to win a prize for creating breakthrough research and technology, adopted by voice vote. Amendment text. Congressional Record p. H5071-H5072

  • July 10, 2015 — Considered by the House. Congressional Record p. H5035-H5082

  • July 9, 2015House Vote 430 Medical Funding and Authorization — Rule
    Adoption of the resolution (H Res 350) that would make in order a bill (HR 6) that would authorize more than $100 billion for medical research and drug development within the Health and Human Services Department (HHS) over a five-year period, including $1.75 billion in advance appropriations each year for research programs at the National Institutes of Health (NIH). Adopted 244-183. Congressional Record p. H5008

  • July 9, 2015House Vote 429 Medical Funding and Authorization — Previous Question
    Burgess, R-Texas, motion to order the previous question (thus ending debate and the possibility of amendment) on the resolution (H Res 350) that would make in order a bill (HR 6) that would authorize more than $100 billion for medical research and drug development within the Health and Human Services Department (HHS) over a five-year period, including $1.75 billion in advance appropriations each year for research programs at the National Institutes of Health (NIH). Motion agreed to 242-185. Congressional Record p. H5007-H5008

  • July 9, 2015 — Considered by the House. Congressional Record p. H5008-H5016

  • July 8, 2015 — Rules Committee resolution, H Res 350, reported to the House as a rule for HR 6.

  • July 8, 2015Statement of Administration Policy issued by Office of Management and Budget.

  • July 8, 2015 — House Rules Committee granted a structured rule providing for consideration of the bill. Congressional Record p. H4943, H4954

  • July 8, 2015 — Full committee consideration and markup held by the House Rules Committee.

    July 8, 2015 — Committee Vote: Rule for Floor Debate on HR 6, Medical Cures Overhaul — Vote to Report

    Provide a structured rule for legislation (HR 6) that would overhaul biomedical research at the National Institutes of Health and the drug approval process at the Food and Drug Administration while designating $9.3 billion in mandatory funding for the agencies over five years that would be fully offset.

    The rule would provide for one hour of general debate equally divided and controlled by the chair and ranking member of the House Energy and Commerce Committee, waiving all points of order against consideration of the bill, provisions in the bill and any amendments made in order.

    It would consider a substitute amendment in the form of a Rules Committee print as adopted. The substitute amendment would eliminate a previous Medicare Part D offset and expands an existing one – a drawdown of the Strategic Petroleum Reserve. It also would shrink a pot of mandatory money for NIH from $10 billion to $8.75 billion from fiscal 2016 to fiscal 2020 and adds policy riders that are included in the annual Labor-HHS spending measure to the bill’s NIH and FDA funding.

    The rule would provide one motion to recommit, with or without instructions. It would make in order the following amendments, debatable for 10 minutes each:

    • Brat, R-Va., that would make the NIH and the FDA money discretionary.
    • Young, R-Iowa, that would allow the NIH to grant an innovation prize for breakthrough research and technologies.
    • Lee, D-Calif., that would strip bill language making Labor-HHS appropriations policy riders applicable to the NIH and the FDA funding stream.
    • Castro, D-Texas, that would ensure minorities and women are included in a report on supporting young emerging scientists.
    • Slaughter, D-N.Y., that would direct the Centers for Disease Control and Prevention to study how additional Medicare payments for antibiotics are affecting the development of drug resistance.
    • Fitzpatrick, R-Pa., that would express the sense of Congress that electronic health records should have unique device identifiers.
    • Polis, D-Colo., that would require the FDA to issue a report on the risks and benefits of an expedited approval process for certain medical devices.
    • Jackson Lee, D-Texas, that would require the Health and Human Services Department to conduct outreach to historically black colleges and universities, Hispanic serving institutions and Native American colleges to ensure underrepresented populations are aware of research opportunities under the bill.
    • Ordered reported favorably to the full House by voice vote.

  • July 7, 2015 — Reported to the House by the House Energy and Commerce Committee and placed on the Union Calendar. H Rept 114-190, Pt. 1Congressional Record p. H4860

  • July 2, 2015Cost Estimate issued by Congressional Budget Office.

  • June 25, 2015 — Additional cosponsor(s): 24

    Brady, R. (D-Pa.)Hoyer, (D-Md.)Lieu, (D-Calif.)
    Brown, C. (D-Fla.)Johnson, E. (D-Texas)Lowenthal, (D-Calif.)
    Calvert, (R-Calif.)Johnson, H. (D-Ga.)Marino, (R-Pa.)
    Chu, (D-Calif.)Keating, (D-Mass.)Perry, (R-Pa.)
    Davis, S. (D-Calif.)Kilmer, (D-Wash.)Roybal-Allard, (D-Calif.)
    Delaney, (D-Md.)Kind, R. (D-Wis.)Ryan, T. (D-Ohio)
    Duckworth, (D-Ill.)Larson, J. (D-Conn.)Waters, (D-Calif.)
    Farr, (D-Calif.)Lewis, John (D-Ga.)Wilson, F. (D-Fla.)
  • June 24, 2015 — Additional cosponsor(s): 17

    Bonamici, (D-Ore.)DelBene, (D-Wash.)Paulsen, (R-Minn.)
    Chabot, (R-Ohio)Hahn, (D-Calif.)Rice, K. (D-N.Y.)
    Cicilline, (D-R.I.)Hunter, (R-Calif.)Rigell, (R-Va.)
    Cleaver (D-Mo.)Langevin, (D-R.I.)Speier, (D-Calif.)
    Collins, D. (R-Ga.)Lipinski, D. (D-Ill.)Stivers, (R-Ohio)
    Cook, (R-Calif.)LoBiondo, (R-N.J.)
  • June 23, 2015Cost Estimate issued by Congressional Budget Office.

  • June 23, 2015 — Additional cosponsor(s): 18

    Boyle, (D-Pa.)Guinta, (R-N.H.)Simpson, M. (R-Idaho)
    Capuano, (D-Mass.)Herrera Beutler, (R-Wash.)Stefanik, (R-N.Y.)
    Conaway, (R-Texas)Jackson Lee, S. (D-Texas)Tiberi, (R-Ohio)
    DesJarlais, (R-Tenn.)Knight, (R-Calif.)Van Hollen, (D-Md.)
    Diaz-Balart, (R-Fla.)Ros-Lehtinen, (R-Fla.)Womack, (R-Ark.)
    Gibbs, B. (R-Ohio)Royce, (R-Calif.)Zinke, (R-Mont.)
  • June 18, 2015 — Additional cosponsor(s): 22

    Bordallo, (D-Guam)Kelly, R. (D-Ill.)Reed, T. (R-N.Y.)
    Crenshaw, (R-Fla.)LaMalfa, (R-Calif.)Sinema, (D-Ariz.)
    Donovan, (R-N.Y.)Maloney, C. (D-N.Y.)Trott, (R-Mich.)
    Ellison, (D-Minn.)McCollum, Betty (D-Minn.)Wasserman Schultz, (D-Fla.)
    Fudge, (D-Ohio)McGovern, (D-Mass.)Webster, (R-Fla.)
    Hastings, (D-Fla.)Moolenaar, (R-Mich.)Wenstrup, (R-Ohio)
    Huizenga, (R-Mich.)Nadler, (D-N.Y.)
    Kaptur, (D-Ohio)Rangel, (D-N.Y.)
  • June 17, 2015 — Additional cosponsor(s): 11

    Ashford, (D-Neb.)Hinojosa, (D-Texas)Moulton, (D-Mass.)
    Cartwright, (D-Pa.)Joyce, (R-Ohio)Valadao, (R-Calif.)
    Edwards, (D-Md.)Katko, (R-N.Y.)Young, D. (R-Iowa)
    Fortenberry, (R-Neb.)McHenry, (R-N.C.)
  • June 16, 2015 — Additional cosponsor(s): 7

    Bost, (R-Ill.)Luetkemeyer, (R-Mo.)Zeldin, (R-N.Y.)
    Clark, K. (D-Mass.)Rogers, Mike D. (R-Ala.)
    Lawrence, (D-Mich.)Velazquez, (D-N.Y.)
  • June 15, 2015 — Additional cosponsor(s): 13

    Barletta, (R-Pa.)Heck, D. (D-Wash.)Takano, (D-Calif.)
    Bera, (D-Calif.)Lofgren, (D-Calif.)Torres, (D-Calif.)
    Denham, (R-Calif.)Meng, (D-N.Y.)Vargas, (D-Calif.)
    Garamendi, (D-Calif.)Pittenger, (R-N.C.)
    Hardy, (R-Nev.)Ruppersberger, (D-Md.)
  • June 11, 2015 — Additional cosponsor(s): 14

    Coffman, (R-Colo.)Meadows, (R-N.C.)Salmon, (R-Ariz.)
    Costello, (R-Pa.)Messer, (R-Ind.)Sires, (D-N.J.)
    Dold, (R-Ill.)Norton, (D-D.C.)Turner, M. (R-Ohio)
    Gutierrez, (D-Ill.)Peters, S. (D-Calif.)Walberg, (R-Mich.)
    Jenkins, E. (R-W.Va.)Pocan, (D-Wis.)
  • June 9, 2015 — Additional cosponsor(s): 17

    Bishop, M. (R-Mich.)Hultgren, (R-Ill.)Polis, (D-Colo.)
    Capps, (D-Calif.)Israel, (D-N.Y.)Roe, (R-Tenn.)
    Cardenas, (D-Calif.)Kirkpatrick, (D-Ariz.)Ross, D. (R-Fla.)
    Curbelo, (R-Fla.)Kuster, (D-N.H.)Walorski, (R-Ind.)
    Dent, (R-Pa.)O'Rourke, (D-Texas)Yoder, (R-Kan.)
    Hudson, (R-N.C.)Payne, D.M. (D-N.J.)
  • June 4, 2015 — Additional cosponsor(s): 1

    Benishek, (R-Mich.)
  • June 3, 2015 — Additional cosponsor(s): 8

    Heck, J. (R-Nev.)Kildee, (D-Mich.)Quigley, (D-Ill.)
    Higgins, (D-N.Y.)Miller, C. (R-Mich.)Takai, (D-Hawaii)
    Huffman, (D-Calif.)Pierluisi, (D-P.R.)
  • June 2, 2015 — Additional cosponsor(s): 11

    Allen, (R-Ga.)Latta, (R-Ohio)Sarbanes, J. (D-Md.)
    Collins, C. (R-N.Y.)Lee, B. (D-Calif.)Scalise, (R-La.)
    Harper, (R-Miss.)Olson, (R-Texas)Walters, (R-Calif.)
    Kinzinger, (R-Ill.)Pompeo, (R-Kan.)
  • June 1, 2015 — Additional cosponsor(s): 13

    Brownley, (D-Calif.)Flores, (R-Texas)Lujan, B. (D-N.M.)
    Bustos, (D-Ill.)Frankel, (D-Fla.)Wagner, (R-Mo.)
    Castro, (D-Texas)Gibson, C. (R-N.Y.)Walz, (D-Minn.)
    Costa, (D-Calif.)Johnson, B. (R-Ohio)
    Davis, R. (R-Ill.)Kennedy (D-Mass.)
  • May 21, 2015 — Energy & Commerce Committee vote: Medical Cures Package-Vote to Report
    Ordered reported favorably to the full House (as amended) 51-0.

  • May 21, 2015 — Full committee consideration and markup held by the House Energy and Commerce Committee.

    May 21, 2015 — Committee Vote: Medical Cures Package — Manager's Amendment
    Upton, R-Mich. —

    Manager’s amendment that would offset the approximate $13 billion cost of the 21st Century Cures bill (HR 6) by drawing down the strategic petroleum reserve to generate $5.2 billion in savings; adjusting the timing of Medicare pre-payments to Part D prescription drug sponsors so that the government keeps the interest revenue instead of the insurers to generate $5 billion to $7 billion in savings; limiting the durable medical equipment reimbursement rates in Medicaid to levels paid by Medicare for $2.8 billion in savings; and limiting federal payments for x-ray imaging services that use film in an effort to incentivize a transition towards digital imaging for $200 million in savings.

    The amendment would establish a Cures Innovation fund at the Food and Drug Administration and provide $110 million in funding for each year from fiscal 2016 through fiscal 2020, with language clarifying that it should supplement not supplant other funds. The amendment would also free FDA user fees from sequestration.

    It would include sense of Congress language to encourage the inclusion of underrepresented communities, including minorities, in clinical trials. It also would encourage Lyme and other tick-borne disease research and the development of new antimicrobial drugs.

    Adopted by voice vote.

    May 21, 2015 — Committee Vote: Medical Cures Package — Vote to Report

    Reauthorize the National Institutes of Health for $31.8 billion in fiscal 2016, $33.3 billion in 2017 and $34.8 million in 2018. The measure would establish an NIH innovation fund, to be provided $2 billion in mandatory funds for each year from fiscal 2016 through fiscal 2020. It would offer student loan forgiveness for some young emerging scientists and capstone awards for outstanding scientists.

    As amended, it would establish a Cures Innovation fund at the Food and Drug Administration and provide $110 million in funding for each year from fiscal 2016 through fiscal 2020, with language clarifying that it should supplement not supplant other funds

    The measure would establish a global pediatric clinical trial network and a national neurological diseases surveillance system, as well as a public-private partnership known as the council for 21st century cures.

    Under the bill, patients could authorize their health information to be used for future research using a single form that sufficiently describes the purpose of the research, but patients could revoke authorization at a later date.

    The measure would require the FDA to establish a structured framework that incorporates patient perspectives into the drug development process. It would require the FDA to issue new guidance on qualifications for biomarkers and how drugs can qualify as precision medicine.

    The measure would encourage the broader use of adaptive clinical trial designs. It would require the FDA to establish a program evaluating the potential use of evidence from clinical experience to support the approval of new drugs and make better use of an existing database that identifies adverse events associated with medical products.

    It would create a streamlined data review program for cancer drugs or biologics that are already approved for use in other areas and allow them to be reviewed based on qualified data summaries. The bill would also define health software and clarify it cannot be subject to regulation.

    It would make it easier for patients to access life-saving experimental drugs outside of an already-approved clinical trial for breakthrough therapies and require drug companies to provide corporate information and criteria for enrolling in expanded access trials.

    It would give companies an extra six months of market exclusivity for new drugs approved for rare diseases and conditions. It also would reauthorize for seven years an FDA program that awards priority reviews of applications to manufacturers of some rare pediatric disease products.

    The bill would establish an expedited approval pathway for antibiotics for serious or life-threatening diseases that would be used in a limited and specific population of patients. It would also allow the FDA to review certain breakthrough vaccines and medical devices in an expedited manner.

    The measure would abolish the cap on the number of staff the FDA is allowed to hire under its senior service core as long as those hired are qualified.

    It would encourage the use of telemedicine and set requirements for the interoperability of electronic health records. The measure also would give the Health and Human Services Department’s inspector general the authority to investigate allegations of information blocking.

    It would allow plan sponsors in Medicare Part D to limit coverage access to a certain pharmacy for beneficiaries considered at-risk for drug abuse.

    As amended, it would offset the approximate $13 billion cost of the bill by drawing down the strategic petroleum reserve to generate $5.2 billion in savings; adjusting the timing of Medicare pre-payments to Part D prescription drug sponsors so that the government keeps the interest revenue instead of the insurers to generate $5 billion to $7 billion in savings; limiting the durable medical equipment reimbursement rates in Medicaid to levels paid by Medicare for $2.8 billion in savings; and limiting federal payments for x-ray imaging services that use film in an effort to incentivize a transition towards digital imaging for $200 million in savings.

    Ordered reported favorably to the full House (as amended) 51-0.
  • May 19, 2015 — Original cosponsor(s): 4

    DeGette, (D-Colo.)Pallone (D-N.J.)
    Green, G. (D-Texas)Pitts, (R-Pa.)
  • May 19, 2015 — Read twice and referred to: House Energy and Commerce, House Ways and Means.Congressional Record p. H3386

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