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Vaccine Access, Certainty, and Innovation Act of 2015
Legislative Progress
Introduced
February 5, 2015
Latest Action
February 27, 2015
Primary Sponsor
Renee L. EllmersRepublican(NC)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
61pct
22d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
Vaccine Access, Certainty, and Innovation Act of 2015 This bill requires the Centers for Disease Control and Prevention (CDC) to report on the process used by the Advisory Committee on Immunization Practices (ACIP) in making recommendations on vaccines. The Department of Health and Human Services (HHS) must issue final guidance to facilitate the use of expedited pathways for the development and licensure of vaccines to prevent certain infectious diseases. The Public Health Service Act is amended to require the CDC to provide a vaccine developer, upon request, with information on public health needs and priorities and certain epidemiological analyses or data. The Federal Food, Drug, and Cosmetic Act is amended to require the Food and Drug Administration to establish a process for designating diseases as tropical diseases included in the priority review voucher program. The amount of the priority review user fee is set to the cost difference between a priority review and a non-priority review. The National Institutes of Health must support or conduct activities to advance the development of vaccines and must report on vaccine research. Within 60 business days of a recommendation by ACIP, HHS must determine whether to update Medicare coverage of vaccines. The Government Accountability Office must report on the impact of Medicare and Medicaid reimbursement rates on vaccine access. For purposes of calculating a medical loss ratio, the cost of a program to increase adult immunization is accounted for: (1) by a private health insurer as an activity that improves health care quality, and (2) by a Medicare Advantage or Part D plan under title XVIII (Medicare) of the Social Security Act as a medical loss.
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Filing registrants (2)
2015 · third_quarter · Health Issues
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Congress.gov source codes: H11100, H11100-A
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $842,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2015 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation 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. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review 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. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing 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 Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues
Client expense: $4,820,000 · Firm income: Not reported
Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2015 · second_quarter · Health Issues
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
Client expense: $1,123,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office