Independent Drug Education and Outreach Act of 2009

H.R. 1859 & S. 767, Independent Drug Education & Outreach Act of 2009; Proposals relating to the "doughnut hole" impact; and implementation of healthcare reform legislation.

Client expense: $580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

H.R. 1859 & S. 767, Independent Drug Education & Outreach Act of 2009; Proposals relating to the "doughnut hole" impact; and implementation of healthcare reform legislation.

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

HR 3962: Affordable Health Care for All America Act HR 3590: Patient Protection and Affordable Care Act HR 1859: Independent Drug Education and Outreach Act of 2009 H Res 1309 HR 4732: Compassionate Access Act of 2010

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1859 & S. 767, Independent Drug Education & Outreach Act of 2009; Proposals relating to the "doughnut hole" impact; and implementation of healthcare reform legislation.

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

HR 3962: Affordable Health Care for All America Act HR 3590: Patient Protection and Affordable Care Act HR 1859: Independent Drug Education and Outreach Act of 2009 H Res 1309

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 301, Physicians Payments Sunshine Act of 2009; H.R. 1859 & S. 767, Independent Drug Education & Outreach Act of 2009; H.R. 1427 & S. 726, Promoting Innovation & Access to Life-Saving Medicine Act; H.R. 1548, Pathway for Biosimilars Act; legislative proposals relating to the "doughnut hole" impact; and FDA implementation of the Food & Drug Administration Amendments Act ("FDAAA")

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

Surface Transportation Authorization Act of 2009, "Reauthorization of SAFETEA-LU," financing methods, workforce development, prevailing wage standards for federally-assisted construction, revenue enhancements, national infrastructure bank, and the role of public-private partnerships. H.R. 272 and H.R. 1806, Freight Rail Infrastructure Capacity Enhancement Act, provisions related to labor standards for federally-assisted construction, Section 4. H.R. 2847, HIRE Act, Extension of current transporation authorization and transfer of $19.5-billion from general fund to the Highway Trust Fund. H.R. 1859, FAA Air Transportation Modernization and Safety Improvement Act, provisions related to funding of Airport Improvement Program and capital investments.

Client expense: $130,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

HR 3962: Affordable Health Care for All America Act HR 3590: Patient Protection and Affordable Care Act HR 1859: Independent Drug Education and Outreach Act of 2009

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 301, Physician Payments Sunshine Act of 2009; H.R. 1859 and S. 767, Independent Drug Education and Outreach Act of 2009; H.R. 1427 and S. 726, Promoting Innovation and Access to Life-Saving Medicine Act; H.R. 1548, Pathway for Biosimilars Act; legislative proposals relating to "doughnut hole" impact; and FDA implementation of the Food & Drug Administration Amendments Act ("FDAAA").

Client expense: $780,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation [S.A. 2793], health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, health reform issues generally S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation S. 1796, Americas Healthy Future Act of 2009: comparative effectiveness, importation, health reform issues generally

HR 3962, Affordable Health Care for All America Act HR 3590, Patient Protection and Affordable Care Act HR 1859, Independent Drug Education and Outreach Act of 2009

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 301, Physician Payments Sunshine Act of 2009; H.R. 1859 and S. 767, Independent Drug Education and Outreach Act of 2009; H.R. 1427 and S. 726, Promoting Innovation and Access to Life-Saving Medicine Act; H.R. 1548, Pathway for Biosimilars Act; legislative proposals relating to "doughnut hole" impact; and FDA implementation of the Food & Drug Administration Amendments Act ("FDAAA").

Client expense: $770,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 3200, America's Affordable Health Choices Act of 2009, all provisions S. 1679, Affordable Health Choices Act, all provisions H.R. 3002, Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2009, all provisions S. 1259, Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2009, all provisions S. 334, Healthy Americans Act, all provisions H.R. 2520, Patients' Choice Act, all provisions S. 1099, Patients' Choice Act, all provisions America's Healthy Future Act of 2009, all provisions Medical Rights and Reform Act (Tuesday Group proposal), all provisions American Health Choices Act (Senate HELP bill), all provisions H.R. 1, American Recovery and Reinvestment Act of 2009, provisions on comparative effectiveness research H.R. 1859, Independent Drug Education and Outreach Act of 2009, all provisions S. 767, Independent Drug Education and Outreach Act of 2009, all provisions H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act, all provisions S. 726, Promoting Innovation and Access to Life-Saving Medicine Act, all provisions H.R. 1548, Pathway for Biosimilars Act, all provisions S. 1142, Informed Health Care Decision Making Act, all provisions S. 1213, Patient-Centered Outcomes Research Act of 2009, all provisions H.R. 2824, Doctor-Patient Relationship and Research Protection Act, all provisions Health System Reform Health System Reform - Medicare Commission Health System Reform - Balance Billing/Private Contracting Health System Reform - Health Savings Accounts Physician-owned Hospitals Comparative Effectiveness Research (CER) Health Information Technology E-prescribing/controlled substances/DEA registration fees HIPAA Administrative Simplification/price transparency Quality improvement/PQRI Value Indexing/Quality FTC Red Flag Rules H1N1 public health emergency issues Patient access to physicians Coverage for the uninsured Patient Safety Non-therapeutic use of antibiotics in agriculture

H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues (drug pricing program for covered entities) H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3200, Americas Affordable Health Choices Act: regulatory approval pathway for follow-on biologics, 340B program issues, comparative effectiveness S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: comparative effectiveness

- HR 1859, "Independent Drug Education & Outreach Act", regarding all provisions as a neutral, expert scientific resource. - S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. - Issues relating to heparin. - Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals, specifically to update Congress on USP standards. - Information on follow-on biologics. - Information on drug quality as a neutral, expert scientific resource.

Client expense: $90,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

HR 1859: Independent Drug Education and Outreach Act of 2009

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

HR 1859: Independent Drug Education and Outreach Act of 2009

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

H.R. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness H.R. 444, 340B Program Improvement and Integrity Act: issues related to 340B program (drug pricing program for covered entities) H.R. 759, Food and Drug Administration Globalization Act of 2009: import safety H.R. 1256, Family Smoking Prevention and Tobacco Control Act: importation H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness House Tri-Committee Health Reform Discussion Draft S. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness S. 350, American Recovery and Reinvestment Act of 2009: comparative effectiveness S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 717, 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act: reimbursement and clinical trial issues S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 882, Drug and Device Accountability Act of 2009: import safety S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. __, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Confirmation of Kathleen Sebelius for Department of Health and Human Services Secretary Confirmation of Margaret Hamburg for Commissioner of Food and Drugs

H.R. 2520, Patients' Choice Act, all provisions S. 1099, Patients' Choice Act, all provisions H.R. 1324, Child Nutrition Promotion and School Lunch Protection Act of 2009, all provisions H.R. 756, National Pain Care Policy Act of 2009, all provisions S. 660, National Pain Care Policy Act of 2009, all provisions H.R. 3002, Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2009, all provisions S. 1259, Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2009, all provisions H.R. 1859, Independent Drug Education and Outreach Act of 2009, all provisions S. 767, Independent Drug Education and Outreach Act of 2009, all provisions H.R. 1549, Preservation of Antibiotics for Medical Treatment Act of 2009, all provisions S. 619, Preservation of Antibiotics for Medical Treatment Act of 2009, all provisions H.R. 2427, Informed Consumer Choices in Health Care Act of 2009, provisions on transparency and accountability H.R. 2502, Comparative Effectiveness Research Act of 2009, all provisions H.R. 2697, Optometric Equity in Medicaid Act of 2009, provision on scope of practice Medical Rights and Reform Act, all provisions Health System Reform - Senate Affordable Health Choices Act, all provisions Health System Reform - Senate Finance Committee Option Papers, all provisions Health System Reform - House Tri-Committee Health Care Reform Discussion Draft, all provisions Health System Reform - AMA principles Health System Reform - Alternatives to current use of housing/rental data to determine physician office costs Health System Reform - Public Plan Option Health System Reform - Insurance Market Reforms AMA Healthy Lifestyles - banning use of artificial trans fats Health Care Quality Improvement - PQRI/AMA Physician Consortium for Performance Improvement (PCPI) Patient Safety FTC Red Flag Rules FTC Breach Notification Requirements for Personal Health Records Mental Health Parity E-prescribing for controlled substances RVS Update Committee (RUC)/Resource-Based Relative Value Scale (RBRVS) Comparative Effectiveness Research HIV/AIDS - Needle Exchange Programs National Health Service Corp - Attracting physicians to serve in underserved areas Health Information Technology - Meaningful Use Health Care Disparities Health Insurance Reform Usual, customary and reasonable fees (UCR) Scope of Practice Opioid drugs - Risk Evaluation and Mitigation Strategy Coverage for the Uninsured Physician-owned Hospitals Rescission of final Provider Conscience Regulation Administrative Simplification - HIPAA/Health System Reform ERISA Preemption of State Prompt Pay Laws

S. 301, Physician Payments Sunshine Act of 2009; H.R. 1859 and S. 767, Independent Drug Education and Outreach Act of 2009; H.R. 1427 and S. 726, Promoting Innovation and Access to Life-Saving Medicine Act; and H.R. 1548, Pathway for Biosimilars Act; legislation and proposals relating to "doughnut hole" impact; and FDA implementation of the Food & Drug Administration Amendments Act ("FDAAA").

Client expense: $840,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.

Client expense: $80,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.

Client expense: $80,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

HR 1859: Independent Drug Education and Outreach Act of 2009

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S. 301, Physician Payments Sunshine Act of 2009; H.R. 1859 and S. 767, Independent Drug Education and Outreach Act of 2009; H.R. 1427 and S. 726, Promoting Innovation and Access to Life-Saving Medicine Act; and H.R. 1548, Pathway for Biosimilars Act; legislation and proposals relating to "doughnut hole" impact; and FDA implementation of the Food & Drug Administration Amendments Act ("FDAAA").

Client expense: $950,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

HR 1859: Independent Drug Education and Outreach Act of 2009

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE