Swift Approval, Full Evaluation Drug Act

HR 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007,” regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; HR 1494 / S 830, “Pediatric Medical Device Safety and Improvement Act of 2007,” regarding improving the process for the development of needed pediatric medical devices; HR 1956, “Patient Protection and Innovative Biologic Medicines Act of 2007,” regarding amending the Public Health Service Act to provide for the approval of similar biological products; HR 2193, “Animal Protection Accountability Improvement Act,” regarding amending the Animal Welfare Act to increase the penalties for violations of such Act and to prohibit the use of animals for marketing medical devices; HR 2349 / S 1413, “Uterine Fibroid Research and Education Act of 2007,” regarding providing for research and education with respect to uterine fibroids; HR 3333 / S. 1576, “Minority Health Improvement and Health Disparity Elimination Act,” regarding amending the Public Health Service Act to improve the health and healthcare of racial and ethnic minority groups; HR 788 / S 468, “Food and Drug Administration Safety Act of 2007,” regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; HR 2900, “Food and Drug Administration Amendments Act of 2007,” regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; S 1082, “Food and Drug Administration Revitalization Act,” regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; S 1695, “Biologics Price Competition and Innovation Act of 2007,” regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products and to promote innovation in the life sciences; S 467, “Fair Access to Clinical Trials Act of 2007 or the `FACT Act',” regarding amending the Public Health Service Act to expand the clinical trials drug data bank; S 558, “Mental Health Parity Act of 2007,” regarding all provisions; S 628, “Critical Access to Health Information Technology Act of 2007,” regarding providing grants for rural health information technology development activities; S 993, “Pediatric Research Improvement Act,” regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine.   HR 1165, “Swift Approval, Full Evaluation Drug Act or the `SAFE Drug Act',” regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals;

Client expense: $3,820,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 1165, Swift Approval, Full Evaluation Drug Act of the "SAFE Drug Act"; (Provisions relating to drug safety.) H.R. 970, Gang Prevention and Effective Deterrence Act of 2005; (Provisions relating to bulk distribution of DXM) H.R. 780, The "Counterfeit Drug Prevention Act of 2007"; (Provisions relating to prevention of counterfeit drugs.)

Client expense: $2,082,850 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

* H.R. 1232/S. 746, To establish a competitive grant program to build capacity in veterinary medical education and expand the workforce of veterinarians engaged in public health practice and biomedical research; Section 2. Competitive Grants; (Provisions relating to entire bill.) S. 438, Fair Prescription Drug Competition Act of 2007; (Sections relating to authorized generics.) H.R. Access to Life -Saving Medicine Act; (Relating to follow-on biologics) H.R. 1165, Swift Approval, Full Evaluation Drug Act of the "SAFE Drug Act"; (Provisions relating to drug safety.) S. 21, A bill to provide for homeland security grant coordination and simplification, and for other purposes; (Sections relating to access to women's health therapies.) H.R. 970, Gang Prevention and Effective Deterrence Act of 2005; (Relating to bulk distribution of DXM.) H.R. 780, Counterfeit Drug Prevention Act of 2007; (Relating to prevention of counterfeit drugs.) H.R. 1282, Medigap Access Improvement Act; (Provisions relating to MediGap and hemophilia patients.) S. 1082, Prescription Drug User Fee Amendments of 2007; (Relating to FDA user fees reauthorization.) Full House Energy & Commerce Committee Markup of Committee prints on: PDUFA, MDUFMA, PREA, BPCA, Drug Safety; (Relating to reauthorization fo FDA user fees and safety.) H.R. 4, Prescription Drug Negotiation Act of 2007; (Provisions concerning repealing non-interference in Medicare.) S. 316, the "Preserve Access to Affordable Generics Act"; (Provisions relating to patent settlements.) 15

Client expense: $2,082,850 · Firm income: Not reported

H.R. 1688 All Healthy Children Act of 2007 S. 325 Health Partnership Act H.R. 15 National Health Insurance Act S. 1169 State Based Health Reform Act S. 1564 All Healthy Children Act of 2007 H.R. 1329 Guaranteed Access for SCHIP’s Target Population Act of 2007 S. 1221 Countdown to Coverage Act of 2007 H.R. 2639 Promoting Health for Future Generations Act of 2007 S. 273 Prescription Drug and Health Improvement Act of 2007 H.R. 2971 Health Care Accountability Act S. 1102 Part D Equity for Low Income Seniors Act of 2007 S. 1753 Health Workforce Act of 2007 S. 1455 National Health Information Technology and Privacy Advancement Act of 2007 S. 1218 Medicare for All Act H.R. 2034 Medicare for All Act S. 895 Children’s Health First Act H.R. 2995 Small Business Liability Reform Act of 2007 H.R. 1012 Small Business Growth Act of 2007 H.R. 1542 Healthy Families Act H.R. 1626 Family Health Care Accessibility Act of 2007 S. 733 Promoting Health Care Purchasing Cooperatives Act H.R. 2351 HealthCARE Act 2007 S. 40 National Insurance Act of 2007 H.R. 493 Genetic Information Nondiscrimination Act of 2007 S. 359 Genetic Information Nondiscrimination Act of 2007 H.R. 677 The Nursing School Capacity Act of 2007 S. 446 Nurse Education, Expansion, and Development Act 0f 2007 H.R. 772 Nurse Education, Expansion, and Development Act 0f 2007 S. 605 Allied Health Reinvestment Act S. 620 Community – Based Health Care Retraining Act H.R. 1279 Direct Support Professionals Fairness and Security Act of 2007 H.R. 1134 Physical Therapist Student Loan Repayment Eligibility Act of 2007 S. 718 Patient – Focused Critical Care Enhancement Act H.R. 1884 National Health Service Corps Improvement Act of 2007 Act H.R. 410 United States Physician Shortage Elimination Act S.224 Standards to Provide Educational Achievement for All Kids H.R. 325 Standards to Provide Educational Achievement for All Kids H.R. 2497 Fair and Reliable Medical Justice Act S. 1481 Fair and Reliable Medical Justice Act H.R. 1174 Healthy Hospitals Act of 2007 H.R. 378 Nurse and Patient Safety and Protection Act of 2007 H.R. 2123 Nurse Staff and Standards for Patient Safety and Quality Care Act of 2007 S. 628 Critical Access to Health Information Technology Act of 2007 S. 1408 Health Information Technology Act of 2007 S. 1577 Patient Safety and Abuse Prevention Act of 2007 S. 1693 Wired for Health Care Quality Act H.R. 2723 Children’s Healthcare Quality Act S. 1226 Children’s Healthcare Quality Act H.R. 1952 National Health Information Incentive Act of 2007 H. R. 2580 Help Efficient, Accessible, Low cost, Timely Healthcare (HEALTH) Act of 2007 S. 1364 Healthy Kids Act of 2007 S. 484 Enhancing Drug Safety and Innovation Act of 2007 H.R. 1561 Enhancing Drug Safety and Innovation Act of 2007 S. 1082 Prescription Drug User Fee Amendments of 2007 H.R. 3014 Health Equity and Accountability Act of 2007 H.R. 1165 SAFE Drug Act S. 1023 “To amend Title XXI of the Social Security Act […]” S. 554 Act for our Kids H.R. 1200 American Health Security Act of 2007 H.R. 15 National Health Insurance Act S. 1224 Children’s Health Insurance Program (CHIP) Reauthorization Act of 2007 H.R. 1368 Personalized Health Information Act of 2007 H.R. 676 United States National Health Insurance Act H.R. 1459 “To improve Medicare beneficiary access […]” H.R. 2737 Health Care Relief Act of 2007 S. 1714 Small Business Children’s Health Education Act of 2007 S. 1198 HealthCARE Act of 2007 H.R. 1802 Keeping Small Business Healthy Act of 2007 H.R. 2626 Comprehensive HealthCARE Act of 2007 H.R. 2842 Children’s Health Protection Act of 2007 S. 95 Kids Come First Act of 2007 H.R. 1111 Kids Come First Act of 2007 H.R. 493 Genetic Information Non-Discrimination Act of 2007 H.R. 2948 Increased Access to Health Insurance Act of 2007 S. 158 Access to Affordable Health Care Act S. 358 Genetic Information Non-Discrimination Act of 2007 H.R. 1012 Small Business Growth Act of 2007 H.R. 2147 Health Kids Act of 2007 S. 1298 Healthy Businesses, Healthy Workers Reinsurance Act of 2007 S. 21 Prevention First Act H.R. 819 Prevention First Act H.R. 593 Children’s Health Insurance Promotion Act of 2007 H.R. 1666 Health Care Price Transparency Promotion Act of 2007 H.R. 2302 Health Insurance Affordability Act of 2007 H.R. 2359 SBA Entrepreneurial Development Programs Act of 2007 H.R. 2357 MediKids Health Insurance Act of 2007 S. 401 Keep Children Covered Act of 2007 S. 2512 Reducing Coverage Gaps for Kids Act of 2007 H.R. 2055 Improving Children’s Access to Health Care Act of 2007 S. 1213 Children’s Express Lane to Heath Coverage Act of 2007 S. 334 Healthy Americans Act S. 1019 Universal Healthcare Choice and Access Act H.R. 1535 Children's Health First Act S. 895 Children's Health First Act