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Legislative Progress
Momentum (last 30 days)
0
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0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
99pct
497d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2016 or the Childhood Cancer STAR Act TITLE I--MAXIMIZING RESEARCH THROUGH DISCOVERY Subtitle A--Caroline Pryce Walker Conquer Childhood Cancer Reauthorization Act (Sec. 101) This bill amends the Public Health Service Act to authorize the National Institutes of Health (NIH) to provide support for the collection of the medical specimens and information of children, adolescents, and young adults with selected cancers that have the least effective treatments in order to achieve a better understanding of these cancers and the effects of treatment. The national childhood cancer registry is reauthorized through FY2021 and revised to authorize the Centers for Disease Control and Prevention to award grants to state cancer registries to improve tracking of childhood cancers. Subtitle B--Pediatric Expertise at NIH (Sec. 111) The National Cancer Advisory Board must include an individual knowledgable in pediatric oncology. Subtitle C--NIH Report on Childhood Cancer Activities (Sec. 121) The Pediatric Research Initiative must annually report on childhood cancer research projects conducted or supported by the NIH. TITLE II--MAXIMIZING DELIVERY: CARE, QUALITY OF LIFE, SURVIVORSHIP, AND CAREGIVER SUPPORT Subtitle A--Childhood Cancer Survivors' Quality of Life Act (Sec. 201) The Department of Health and Human Services (HHS) may support pilot programs to develop or study models for monitoring and caring for childhood cancer survivors throughout their lives. HHS must convene a Workforce Development Collaborative on Medical and Psychosocial Care for Pediatric Cancer Survivors. (Sec. 202) The NIH may support research on: (1) outcomes for, and barriers faced by, pediatric cancer survivors within minority or medically underserved populations; and (2) follow-up care for pediatric cancer survivors, including research on the late effects of cancer treatment and long-term complications. (Sec. 203) HHS may establish a task force on standards for high-quality childhood cancer survivorship care. (Sec. 204) HHS may carry out a demonstration project to improve care coordination as childhood cancer survivors transition to adult care. Subtitle B--Coverage and Payment of High Quality Care (Sec. 211) The Government Accountability Office must make recommendations to address barriers to childhood cancer survivors obtaining and paying for adequate medical care.
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Filing registrants (11)
Received in the Senate.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7193-7196)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H7193-7196)
DEBATE - The House proceeded with forty minutes of debate on H.R. 3381.
Considered under suspension of the rules. (consideration: CR H7193-7198)
Mr. Burgess moved to suspend the rules and pass the bill, as amended.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2016 · fourth_quarter · Health Issues
Issues relating to health disparities, health care reform, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.3119 & S.2748, the Palliative Care and Hospice Education and Training Act; H.R.716 & S.370, the Breast Density & Mammography Reporting Act; H.R.3381 & S.1883, Childhood Cancer STAR Act; and regulations relating to tanning beds. In addition, regulatory issues before the FDA relating to laboratory developed tests, and any legislation pertaining thereto, suncreens, colorectal cancer screening tests, electronic medical devices, H.R.2739/S.1566 - the Cancer Drug Coverage Parity Act, H.R.2846 - Planning Actively for Cancer Treatment Act, S.1014 - Personal Care Products Safety Act, H.R.1608 - Lymphedema Treatment Act, H.R.2191/S.1170 - the Breast Cancer Research Stamp Reauthorization Act, S.705 - Transportation Alternatives Act, S.540 - School Food Modernization Act, and H.R.644 - America Gives More Act, CDC opioid prescription guidelines, and legislation relating to opioid prescribing, addition and rehabilitation; H.R.5475, the Health Equity and Accountability Act; S.2787, the SAME Act and Senate Amendment 4369 to S.2943, the Senate Defense Authorization bill; and S.3136, H.R.5003 childhood nutrition bill; and H.R.2017 and S.2217, the Common Sense Nutrition Disclosure Act; and S.524 and H.R.953, the Comprehensive Addiction and Recovery Act, and related bills and amendments, S.3077, the Marijuana Effective Drug Studies Act of 2016.
Client expense: $1,640,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Health Issues
S. 1883/H.R. 3381, a bill to maximize discovery and accelerate development and availability of childhood cancer treatments; BPCA and PREA reform.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
2016 · fourth_quarter · Health Issues
S. 524 Comprehensive Addiction and Recovery Act of 2016 Senate HELP Committee Innovations Package HR 6 21st Century Cures Act HR 1600 Patients Access to Treatment Act of 2015 HR 2739/S 1566 Cancer Drug Coverage Parity Act HR 3381/S 1883 Childhood Cancer STAR Act HR 3119 Palliative Care Hospice Education and Training Act S 2141 Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015 H.R. 2846 Planning Actively for Cancer Treatment (PACT) Act of 2015 S. 2511 Improving Health Information Technology Act Reforms to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Client expense: $65,519 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Funding for the National Cancer Institute H.R. 3381 The Childhood Cancer STAR Act S. 1883 The Childhood Cancer STAR Act
Client expense: Not reported · Firm income: $22,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
| Democratic |
| CA |
| Albio Sires | Democratic | NJ |
| Alcee L. Hastings | Democratic | FL |
| Alma S. Adams | Democratic | NC |
| André Carson | Democratic | IN |
| Andy Barr | Republican | KY |
| Ann Kirkpatrick | Democratic | AZ |
| Ann M. Kuster | Democratic | NH |
| Anna G. Eshoo | Democratic | CA |
| Barbara Comstock | Republican | VA |
| Barbara Lee | Democratic | CA |
| Ben Ray Luján | Democratic | NM |
| Betty McCollum | Democratic | MN |
| Bill Flores | Republican | TX |
| Bill Foster | Democratic | IL |
| Bill Johnson | Republican | OH |
| Bill Pascrell, Jr. | Democratic | NJ |
| Blaine Luetkemeyer | Republican | MO |
| Blake Farenthold | Republican | TX |
| Bob Gibbs | Republican | OH |
| Bob Goodlatte | Republican | VA |
| Bobby L. Rush | Democratic | IL |
| Bonnie Watson Coleman | Democratic | NJ |
| Brad Ashford | Democratic | NE |
| Brad R. Wenstrup | Republican | OH |
| Brendan F. Boyle | Democratic | PA |
| Brett Guthrie | Republican | KY |
| Brian Higgins | Democratic | NY |
| Bruce Poliquin | Republican | ME |
| C. A. Dutch Ruppersberger | Democratic | MD |
| Candice S. Miller | Republican | MI |
| Carlos Curbelo | Republican | FL |
| Carolyn B. Maloney | Democratic | NY |
| Cathy McMorris Rodgers | Republican | WA |
| Cedric L. Richmond | Democratic | LA |
| Chaka Fattah | Democratic | PA |
| Charles B. Rangel | Democratic | NY |
| Charles W. Boustany Jr. | Republican | LA |
| Charles W. Dent | Republican | PA |
| Chellie Pingree | Democratic | ME |
| Cheri Bustos | Democratic | IL |
| Chris Collins | Republican | NY |
| Chris Van Hollen | Democratic | MD |
| Christopher H. Smith | Republican | NJ |
| Christopher P. Gibson | Republican | NY |
| Collin C. Peterson | Democratic | MN |
| Corrine Brown | Democratic | FL |
| Dan Newhouse | Republican | WA |
| Daniel Lipinski | Democratic | IL |
| Daniel M. Donovan, Jr. | Republican | NY |
| Daniel T. Kildee | Democratic | MI |
| Danny K. Davis | Democratic | IL |
| Darin LaHood | Republican | IL |
| David E. Price | Democratic | NC |
| David G. Reichert | Republican | WA |
| David Loebsack | Democratic | IA |
| David N. Cicilline | Democratic | RI |
| David P. Joyce | Republican | OH |
| David Scott | Democratic | GA |
| David W. Jolly | Republican | FL |
| David Young | Republican | IA |
| Debbie Wasserman Schultz | Democratic | FL |
| Dennis A. Ross | Republican | FL |
| Denny Heck | Democratic | WA |
| Derek Kilmer | Democratic | WA |
| Diana DeGette | Democratic | CO |
| Dina Titus | Democratic | NV |
| Don Young | Republican | AK |
| Donald Norcross | Democratic | NJ |
| Donald S. Beyer, Jr. | Democratic | VA |
| Donna F. Edwards | Democratic | MD |
| Doris O. Matsui | Democratic | CA |
| Doug LaMalfa | Republican | CA |
| Doug Lamborn | Republican | CO |
| Duncan Hunter | Republican | CA |
| E. Scott Rigell | Republican | VA |
| Earl Blumenauer | Democratic | OR |
| Ed Perlmutter | Democratic | CO |
| Eddie Bernice Johnson | Democratic | TX |
| Eleanor Holmes Norton | Democratic | DC |
| Elijah E. Cummings | Democratic | MD |
| Eliot L. Engel | Democratic | NY |
| Elise M. Stefanik | Republican | NY |
| Elizabeth H. Esty | Democratic | CT |
| Eric A. "Rick" Crawford | Republican | AR |
| Eric Swalwell | Democratic | CA |
| Erik Paulsen | Republican | MN |
| F. James Sensenbrenner, Jr. | Republican | WI |
| Filemon Vela | Democratic | TX |
| Frank A. LoBiondo | Republican | NJ |
| Frank C. Guinta | Republican | NH |
| Frederica S. Wilson | Democratic | FL |
| G. K. Butterfield | Democratic | NC |
| Gerald E. Connolly | Democratic | VA |
| Glenn Grothman | Republican | WI |
| Glenn Thompson | Republican | PA |
| Grace F. Napolitano | Democratic | CA |
| Grace Meng | Democratic | NY |
| Greg Walden | Republican | OR |
| Gregg Harper | Republican | MS |
| Gregory W. Meeks | Democratic | NY |
| Gus M. Bilirakis | Republican | FL |
| Gwen Graham | Democratic | FL |
| Gwen Moore | Democratic | WI |
| H. Morgan Griffith | Republican | VA |
| Hakeem S. Jeffries | Democratic | NY |
| Henry Cuellar | Democratic | TX |
| Ileana Ros-Lehtinen | Republican | FL |
| J. French Hill | Republican | AR |
| J. Randy Forbes | Republican | VA |
| Jackie Speier | Democratic | CA |
| Jaime Herrera Beutler | Republican | WA |
| James A. Himes | Democratic | CT |
| James P. McGovern | Democratic | MA |
| James R. Langevin | Democratic | RI |
| Janice D. Schakowsky | Democratic | IL |
| Janice Hahn | Democratic | CA |
| Jared Huffman | Democratic | CA |
| Jared Polis | Democratic | CO |
| Jeff Denham | Republican | CA |
| Jeff Duncan | Republican | SC |
| Jeff Fortenberry | Republican | NE |
| Jeff Miller | Republican | FL |
| Jerry McNerney | Democratic | CA |
| Jim McDermott | Democratic | WA |
| Joaquin Castro | Democratic | TX |
| Joe Barton | Republican | TX |
| Joe Courtney | Democratic | CT |
| Joe Wilson | Republican | SC |
| John A. Yarmuth | Democratic | KY |
| John Abney Culberson | Republican | TX |
| John B. Larson | Democratic | CT |
| John C. Carney Jr. | Democratic | DE |
| John Conyers, Jr. | Democratic | MI |
| John Garamendi | Democratic | CA |
| John J. Duncan, Jr. | Republican | TN |
| John K. Delaney | Democratic | MD |
| John Katko | Republican | NY |
| John Lewis | Democratic | GA |
| John P. Sarbanes | Democratic | MD |
| Joseph J. Heck | Republican | NV |
| Joseph P. Kennedy III | Democratic | MA |
| José E. Serrano | Democratic | NY |
| Joyce Beatty | Democratic | OH |
| Judy Chu | Democratic | CA |
| Julia Brownley | Democratic | CA |
| Karen Bass | Democratic | CA |
| Katherine M. Clark | Democratic | MA |
| Kathleen M. Rice | Democratic | NY |
| Kathy Castor | Democratic | FL |
| Kay Granger | Republican | TX |
| Keith Ellison | Democratic | MN |
| Kevin Cramer | Republican | ND |
| Kurt Schrader | Democratic | OR |
| Kyrsten Sinema | Independent | AZ |
| Larry Bucshon | Republican | IN |
| Lee M. Zeldin | Republican | NY |
| Leonard Lance | Republican | NJ |
| Lloyd Doggett | Democratic | TX |
| Lois Capps | Democratic | CA |
| Lois Frankel | Democratic | FL |
| Loretta Sanchez | Democratic | CA |
| Lou Barletta | Republican | PA |
| Louise McIntosh Slaughter | Democratic | NY |
| Lucille Roybal-Allard | Democratic | CA |
| Luis V. Gutiérrez | Democratic | IL |
| Luke Messer | Republican | IN |
| Lynn Jenkins | Republican | KS |
| Marc A. Veasey | Democratic | TX |
| Marcia L. Fudge | Democratic | OH |
| Marcy Kaptur | Democratic | OH |
| Mark DeSaulnier | Democratic | CA |
| Mark Meadows | Republican | NC |
| Mark Pocan | Democratic | WI |
| Mark Sanford | Republican | SC |
| Mark Takai | Democratic | HI |
| Mark Takano | Democratic | CA |
| Markwayne Mullin | Republican | OK |
| Marsha Blackburn | Republican | TN |
| Matt Cartwright | Democratic | PA |
| Michael C. Burgess | Republican | TX |
| Michael E. Capuano | Democratic | MA |
| Michael F. Doyle | Democratic | PA |
| Michael G. Fitzpatrick | Republican | PA |
| Michael M. Honda | Democratic | CA |
| Michael R. Turner | Republican | OH |
| Michelle Lujan Grisham | Democratic | NM |
| Mike Bishop | Republican | MI |
| Mike Bost | Republican | IL |
| Mike Coffman | Republican | CO |
| Mike Kelly | Republican | PA |
| Mike Pompeo | Republican | KS |
| Mike Quigley | Democratic | IL |
| Mike Thompson | Democratic | CA |
| Niki Tsongas | Democratic | MA |
| Nita M. Lowey | Democratic | NY |
| Norma J. Torres | Democratic | CA |
| Nydia M. Velázquez | Democratic | NY |
| Patrick Meehan | Republican | PA |
| Patrick Murphy | Democratic | FL |
| Paul Tonko | Democratic | NY |
| Pete Sessions | Republican | TX |
| Peter A. DeFazio | Democratic | OR |
| Peter J. Roskam | Republican | IL |
| Peter T. King | Republican | NY |
| Peter Welch | Democratic | VT |
| Randy Hultgren | Republican | IL |
| Raúl M. Grijalva | Democratic | AZ |
| Reid J. Ribble | Republican | WI |
| Richard B. Nugent | Republican | FL |
| Richard E. Neal | Democratic | MA |
| Richard Hudson | Republican | NC |
| Richard L. Hanna | Republican | NY |
| Richard M. Nolan | Democratic | MN |
| Robert A. Brady | Democratic | PA |
| Robert E. Latta | Republican | OH |
| Robert J. Dold | Republican | IL |
| Robert J. Wittman | Republican | VA |
| Robert Pittenger | Republican | NC |
| Robin L. Kelly | Democratic | IL |
| Rod Blum | Republican | IA |
| Rodney Davis | Republican | IL |
| Rodney P. Frelinghuysen | Republican | NJ |
| Ron Kind | Democratic | WI |
| Rosa L. DeLauro | Democratic | CT |
| Ruben Gallego | Democratic | AZ |
| Rubén Hinojosa | Democratic | TX |
| Ryan A. Costello | Republican | PA |
| Sam Farr | Democratic | CA |
| Sam Graves | Republican | MO |
| Sanford D. Bishop, Jr. | Democratic | GA |
| Scott H. Peters | Democratic | CA |
| Scott R. Tipton | Republican | CO |
| Sean P. Duffy | Republican | WI |
| Sean Patrick Maloney | Democratic | NY |
| Seth Moulton | Democratic | MA |
| Sheila Jackson Lee | Democratic | TX |
| Stephen F. Lynch | Democratic | MA |
| Stephen Knight | Republican | CA |
| Steve Cohen | Democratic | TN |
| Steve Israel | Democratic | NY |
| Steve King | Republican | IA |
| Steve Stivers | Republican | OH |
| Susan A. Davis | Democratic | CA |
| Susan W. Brooks | Republican | IN |
| Suzan K. DelBene | Democratic | WA |
| Suzanne Bonamici | Democratic | OR |
| Tammy Duckworth | Democratic | IL |
| Ted Lieu | Democratic | CA |
| Ted Poe | Republican | TX |
| Terri A. Sewell | Democratic | AL |
| Theodore E. Deutch | Democratic | FL |
| Thomas J. Rooney | Republican | FL |
| Tim Murphy | Republican | PA |
| Tim Ryan | Democratic | OH |
| Tim Walberg | Republican | MI |
| Timothy J. Walz | Democratic | MN |
| Todd Rokita | Republican | IN |
| Todd Young | Republican | IN |
| Tom Marino | Republican | PA |
| Tom Reed | Republican | NY |
| Tony Cárdenas | Democratic | CA |
| Vern Buchanan | Republican | FL |
| Will Hurd | Republican | TX |
| William R. Keating | Democratic | MA |
| Yvette D. Clarke | Democratic | NY |
| Zoe Lofgren | Democratic | CA |
Client expense: $4,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Issues relating to health disparities, health care reform, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.3119 & S.2748, the Palliative Care and Hospice Education and Training Act; H.R.716 & S.370, the Breast Density & Mammography Reporting Act; H.R.3381 & S.1883, Childhood Cancer STAR Act; and regulations relating to tanning beds. In addition, regulatory issues before the FDA relating to laboratory developed tests, and any legislation pertaining thereto, suncreens, colorectal cancer screening tests, electronic medical devices, H.R.2739/S.1566 - the Cancer Drug Coverage Parity Act, H.R.2846 - Planning Actively for Cancer Treatment Act, S.1014 - Personal Care Products Safety Act, H.R.1608 - Lymphedema Treatment Act, H.R.2191/S.1170 - the Breast Cancer Research Stamp Reauthorization Act, S.705 - Transportation Alternatives Act, S.540 - School Food Modernization Act, and H.R.644 - America Gives More Act, CDC opioid prescription guidelines, and legislation relating to opioid prescribing, addition and rehabilitation; H.R.5475, the Health Equity and Accountability Act; S.2787, the SAME Act and Senate Amendment 4369 to S.2943, the Senate Defense Authorization bill; and S.3136, H.R.5003 childhood nutrition bill; and H.R.2017 and S.2217, the Common Sense Nutrition Disclosure Act; and S.524 and H.R.953, the Comprehensive Addiction and Recovery Act, and related bills and amendments, S.3077, the Marijuana Effective Drug Studies Act of 2016.
Client expense: $1,620,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Health Issues
H.R. 6, H.R. 34 & Public Law 114-255, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; S.3239, RACE for Children Act; Expanded Access (legislation not introduced) H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act; S. 2023, Prescription Drug Affordability Act of 2015; H.R. 6501, Prescription Drug and Medical Device Price Review Board Act of 2016; S.3455, Pharmaceutical Supply and Value Enhancement Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act (no legislation introduced);
Client expense: $1,040,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health Issues
Issues relating to health disparities, health care reform, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.3119 & S.2748, the Palliative Care and Hospice Education and Training Act; H.R.716 & S.370, the Breast Density & Mammography Reporting Act; H.R.3381 & S.1883, Childhood Cancer STAR Act; and regulations relating to tanning beds. In addition, regulatory issues before the FDA relating to laboratory developed tests, and any legislation pertaining thereto, suncreens, colorectal cancer screening tests, electronic medical devices, H.R.2739/S.1566 - the Cancer Drug Coverage Parity Act, H.R.2846 - Planning Actively for Cancer Treatment Act, S.1014 - Personal Care Products Safety Act, H.R.1608 - Lymphedema Treatment Act, H.R.2191/S.1170 - the Breast Cancer Research Stamp Reauthorization Act, S.705 - Transportation Alternatives Act, S.540 - School Food Modernization Act, and H.R.644 - America Gives More Act, CDC opioid prescription guidelines, and legislation relating to opioid prescribing, addition and rehabilitation; H.R.5475, the Health Equity and Accountability Act; S.2787, the SAME Act and Senate Amendment 4369 to S.2943, the Senate Defense Authorization bill; and S.3136, H.R.5003 childhood nutrition bill; and H.R.2017 and S.2217, the Common Sense Nutrition Disclosure Act; and S.524 and H.R.953, the Comprehensive Addiction and Recovery Act, and related bills and amendments, S.3077, the Marijuana Effective Drug Studies Act of 2016.
Client expense: $1,630,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Health Issues
H.R.34, 21st Century Cures Act (P.L.114-255). S.1767, Combination Product Regulatory Fairness Act of 2015. H.R.2433, To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review. H.R.3381/S.1883, Childhood Cancer STAR Act. S.1014, Personal Care Products Safety Act. Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Funding for the National Cancer Institute H.R. 3381 The Childhood Cancer STAR Act S. 1883 The Childhood Cancer STAR Act
Client expense: Not reported · Firm income: $25,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;
Client expense: $2,610,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · third_quarter · Health Issues
S. 524 Comprehensive Addiction and Recovery Act of 2016 Senate HELP Committee Innovations Package HR 6 21st Century Cures Act HR 1600 Patients Access to Treatment Act of 2015 HR 2739/S 1566 Cancer Drug Coverage Parity Act HR 3381/S 1883 Childhood Cancer STAR Act HR 3119 Palliative Care Hospice Education and Training Act S 2141 Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015 H.R. 2846 Planning Actively for Cancer Treatment (PACT) Act of 2015 S. 2511 Improving Health Information Technology Act Reforms to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Client expense: $169,982 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program - Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · third_quarter · Health Issues
Issues relating to health disparities, health care reform, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.3119 & S.2748, the Palliative Care and Hospice Education and Training Act; H.R.716 & S.370, the Breast Density & Mammography Reporting Act; H.R.3381 & S.1883, Childhood Cancer STAR Act; and regulations relating to tanning beds. In addition, regulatory issues before the FDA relating to laboratory developed tests, and any legislation pertaining thereto, suncreens, colorectal cancer screening tests, electronic medical devices, H.R.2739/S.1566 - the Cancer Drug Coverage Parity Act, H.R.2846 - Planning Actively for Cancer Treatment Act, S.1014 - Personal Care Products Safety Act, H.R.1608 - Lymphedema Treatment Act, H.R.2191/S.1170 - the Breast Cancer Research Stamp Reauthorization Act, S.705 - Transportation Alternatives Act, S.540 - School Food Modernization Act, and H.R.644 - America Gives More Act, CDC opioid prescription guidelines, and legislation relating to opioid prescribing, addition and rehabilitation; H.R.5475, the Health Equity and Accountability Act; S.2787, the SAME Act and Senate Amendment 4369 to S.2943, the Senate Defense Authorization bill; and S.3136, H.R.5003 childhood nutrition bill; and H.R.2017 and S.2217, the Common Sense Nutrition Disclosure Act; and S.524 and H.R.953, the Comprehensive Addiction and Recovery Act, and related bills and amendments, S.3077, the Marijuana Effective Drug Studies Act of 2016.
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
Client expense: $4,550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $4,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Health Issues
H.R.6, 21st Century Cures Act. S.1767, Combination Product Regulatory Fairness Act of 2015. H.R.2433, To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review. H.R.3381/S.1883, Childhood Cancer STAR Act. S.1014, Personal Care Products Safety Act. Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
S. 1883/H.R. 3381, a bill to maximize discovery and accelerate development and availability of childhood cancer treatments; BPCA and PREA reform.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Funding for the National Cancer Institute H.R. 3381 The Childhood Cancer STAR Act S. 1883 The Childhood Cancer STAR Act
Client expense: Not reported · Firm income: $25,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Issues relating to health disparities, health care reform, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.3119 & S.2748, the Palliative Care and Hospice Education and Training Act; H.R.716 & S.370, the Breast Density & Mammography Reporting Act; H.R.3381 & S.1883, Childhood Cancer STAR Act; and regulations relating to tanning beds. In addition, regulatory issues before the FDA relating to laboratory developed tests, and any legislation pertaining thereto, suncreens, colorectal cancer screening tests, electronic medical devices, H.R.2739/S.1566 - the Cancer Drug Coverage Parity Act, H.R.2846 - Planning Actively for Cancer Treatment Act, S.1014 - Personal Care Products Safety Act, H.R.1608 - Lymphedema Treatment Act, H.R.2191/S.1170 - the Breast Cancer Research Stamp Reauthorization Act, S.705 - Transportation Alternatives Act, S.540 - School Food Modernization Act, and H.R.644 - America Gives More Act, CDC opioid prescription guidelines, and legislation relating to opiod prescribing, addition and rehabilitation; H.R.5475, the Health Equity and Accountability Act; S.2787, the SAME Act and Senate Amendment 4369 to S.2943, the Senate Defense Authorization bill; and S.3136, H.R.5003 childhood nutrition bill; and H.R.2017 and S.2217, the Common Sense Nutrition Disclosure Act; and S.524 and H.R.953, the Comprehensive Addiction and Recovery Act, and related bills and amendments.
Client expense: $1,250,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Other: - Kids Innovative Drugs Act (draft) - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances - Drug Supply Chain Security Act policy issues - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial sizes policy issues - House Republican Health Proposal (A Better Way)
Client expense: $1,070,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
S. 524 Comprehensive Addiction and Recovery Act of 2016 Senate HELP Committee Innovations Package HR 6 21st Century Cures Act HR 1600 Patients Access to Treatment Act of 2015 HR 2739/S 1566 Cancer Drug Coverage Parity Act HR 3381/S 1883 Childhood Cancer STAR Act HR 3119 Palliative Care Hospice Education and Training Act S 2141 Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015 H.R. 2846 Planning Actively for Cancer Treatment (PACT) Act of 2015 S. 2511 Improving Health Information Technology Act Reforms to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Client expense: $92,141 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
Client expense: $5,820,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
S. 1883/H.R. 3381, a bill to maximize discovery and accelerate development and availability of childhood cancer treatments; BPCA and PREA reform.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;
Client expense: $2,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · first_quarter · Health Issues
H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;
Client expense: $26,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · second_quarter · Health Issues
H.R.6, 21st Century Cures Act. S.1767, Combination Product Regulatory Fairness Act of 2015. H.R.2433, To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review. H.R.3381/S.1883, Childhood Cancer STAR Act. Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Funding for the National Cancer Institute H.R. 3381 The Childhood Cancer STAR Act S. 1883 The Childhood Cancer STAR Act
Client expense: Not reported · Firm income: $22,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
S. 1883/H.R. 3381, a bill to maximize discovery and accelerate development and availability of childhood cancer treatments
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;
Client expense: $2,570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · first_quarter · Health Issues
H.R. 6, 21st Century Cures Act S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 471 & S. 483, Ensuring Patient Access and Effective Drug Enforcement of 2015; H.R. 1725 & S. 480, National All Schedules Prescription Electronic Reporting Reauthorization of 2015; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation of The Prescription Drug User Fee Act (PDUFA); Implementation of The Biosimilars User Fee Act (BsUFA); Public Law 113-54, Drug Quality & Security Act; H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016;
Client expense: $2,630,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2016 · first_quarter · Health Issues
Senate HELP Committee Innovations Package HR 6 21st Century Cures Act HR 1600 Patients Access to Treatment Act of 2015 HR 2739/S 1566 Cancer Drug Coverage Parity Act HR 3381/S 1883 Childhood Cancer STAR Act HR 3119 Palliative Care Hospice Education and Training Act S 2141 Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015 H.R. 2846 Planning Actively for Cancer Treatment (PACT) Act of 2015 S. 2511 Improving Health Information Technology Act S.524 Comprehensive Addiction and Recovery Act of 2016
Client expense: $98,340 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Medical/Disease Research/Clinical Labs
Implementation of the National Research Pediatric Research Act, all provisions; 340B Program, continuation of eligibility for childrens hospitals; H.R. 3381, The Childhood Cancer Survivorship Treatment, Access and Research Act, all provisions; S.1883, The Childhood Cancer Survivorship Treatment, Access and Research Act, all provisions; Mental Health Reform Act of 2016, section 503 telehealth child psychiatry access program; Administrations Cancer Moonshot initiative, ensure appropriate representation of pediatric issues.
Client expense: $100,000 · Firm income: Not reported
Government targets: Administration for Children & Families (ACF), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE
2015 · fourth_quarter · Health Issues
Senate HELP Committee Innovations Package HR 6 21st Century Cures Act HR 1600 Patients Access to Treatment Act of 2015 HR 2739/S 1566 Cancer Drug Coverage Parity Act HR 3381/S 1883 Childhood Cancer STAR Act HR 3119 Palliative Care Hospice Education and Training Act S 2141 Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015 H.R. 2846 Planning Actively for Cancer Treatment (PACT) Act of 2015
Client expense: $53,150 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Funding for the National Cancer Institute H.R. 3381 The Childhood Cancer STAR Act S. 1883 The Childhood Cancer STAR Act
Client expense: Not reported · Firm income: $22,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
S. 1883/H.R. 3381, a bill to maximize discovery and accelerate development and availability of childhood cancer treatments
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Medical/Disease Research/Clinical Labs
Implementation of the National Research Pediatric Research Act, all provisions; 340B Program, continuation of eligibility for childrens hospitals; H.R. 3381, The Childhood Cancer Survivorship Treatment, Access and Research Act, all provisions; S.1883, The Childhood Cancer Survivorship Treatment, Access and Research Act, all provisions.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
Funding for the National Cancer Institute H.R. 3381 The Childhood Cancer STAR Act S. 1883 The Childhood Cancer STAR Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
HR 6 21st Century Cures Act HR 1600 Patients Access to Treatment Act of 2015 HR 2739/S 1566 Cancer Drug Coverage Parity Act HR 3381/S 1883 Childhood Cancer STAR Act HR 3119 Palliative Care Hospice Education and Training Act S 2141 Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Medical/Disease Research/Clinical Labs
21st Century Cures Act, HR 6 Childhood Cancer STAR Act, S 1883 and HR 3381
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Medical/Disease Research/Clinical Labs
Implementation of the National Research Pediatric Research Act, all provisions; 21st Century Cures Act, provisions related to the National Research Pediatric Research Act; 340B Program, continuation of eligibility for childrens hospitals; H.R. 3381, The Childhood Cancer Survivorship Treatment, Access and Research Act; S.1883, The Childhood Cancer Survivorship Treatment, Access and Research Act.
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
S. 1883/H.R. 3381, a bill to maximize discovery and accelerate development and availability of childhood cancer treatments
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Health Issues
S. 1883/H.R. 3381, a bill to maximize discovery and accelerate development and availability of childhood cancer treatments
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · first_quarter · Intelligence
H.R.3381, S.1681 FY14 Intelligence Authorization Act, Cybersecurity, Intelligence programs; H.R.4681 - Intelligence Authorization Act for Fiscal Years 2014 and 2015.
Client expense: $2,240,000 · Firm income: Not reported
Government targets: Air Force, Dept of, Army, Dept of (Other), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Navy, Dept of, SENATE