Informed Health Care Decision Making Act

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions. - Issues relating to the McNeil recall of over the counter medications. - H.R. 2923, "A bill to Enhance the ability to combat Methamphetamine", regarding all provisions. - H.R. 5786, "Safe Cosmetics Act of 2010", regarding all provisions.

Client expense: $850,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

General Issues related to healthcare, healthcare reimbursement, healthcare reform, and the FDA device approval process; S.1213 Patient Centered Outcomes Rresearch Act- issues regarding all provisions; S. 1142 - Informed Health Care Decision Making Act- issues regarding all provision; Issues related to FDA 510(K) legislative changes; S.1679 - Affordable Health Choice Act- issues related comparative effectiveness & physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - issues related comparative effectiveness & physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009"- issues related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010- issues related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general; House Resolutions 1438, Promoting Increased Awareness and Diagnosis of Peripheral Arterial Disease - Generally; General issues related to BPA.

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information. H.R.1032, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. S.422, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.

Client expense: $450,000 · 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), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

Client expense: $450,000 · 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), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

General Issues related to healthcare, healthcare reimbursement, healthcare reform, and the FDA device approval process; S.1213 Patient Centered Outcomes research Act- issues regarding all provisions; S. 1142 - Informed health care Decision Making Act- issues regarding all provision; Issues related to FDA 510(K) legislative changes; S.1679 - Affordable Health Choice Act- issues related comparative effectiveness & physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - issues related comparative effectiveness & physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009"- issues related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010- issues related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general; House Resolutions 1438, Promoting Increased Awareness and Diagnosis of Peripheral Arterial Disease - Generally

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions. - Issues relating to the McNeil recall of over the counter medications. - H.R. 2923, "A bill to Enhance the ability to combat Methamphetimine", regarding all provisions. - H.R. 5786, "Safe Cosmetics Act of 2010", regarding all provisions.

Client expense: $2,410,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

S. 1679 Kennedy Health Care Reform Bill Senate Finance Committee Health Care Reform Bill H.R. 3200 Tri-Committee Health Care Reform Bill S. 1213, H.R. 2502 Comparative Effectiveness Research S. 1142 - Informed Health Care Decision Making Act H.R. 3276 - Nuclear Medicine and Research Legislation Medical Device Tax H.R. 3590 - Patient Protection and Affordable Care Act H.R. 4872 - Health Care and Education Reconciliation Act of 2010 H.R. 4956 - Stop Oxy Abuse Act of 2010 Issues related to 510(k) changes

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information. H.R.1032, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. S.422, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.

Client expense: $490,000 · 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), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

Client expense: $490,000 · 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), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

HR 6228/S 593 the Ban Poisonous act of 2009, a bill to ban the use of Bisphenol-A in food containers, and for other purposes; (All provisions pertaining to the ban of food contact applications and the science used to support the ban on Bisphenol-A containing products.) S 753 The Children's Safe Chemical Act, a ban on food contact materials for children and infants (3 years and under); (All provisions and amendments pertaining to the ban and the testing are relevant.) HR 4341 Bisphenol-A Consumer Information Act 2009, a bill to amend the Food, Drug, and Cosmetic Act to require a warning on the lable of any food container that is composed, in whole or in part, of Bisphenol-A or could release Bisphenol-A into the food; (All provisions relating to the science, restrictions on use and applications of Bisphenol-A in food applications.) HR 2749 Food Safety Enhancement Act of 2009, a reform of the law on food safety protection; (All provisions pertaining to the FDA mandate to make a safety determination on BPA before the end of the year.) HR 1549/S 619 To amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal disease; (Title II. General provisions in the bill.) HR 2749 Food Safety Enhancement Act of 2009 To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other puposes; (Title I food Safety,; Monitoring food safety provisions.) HR 2400 Strategies to Address Antimicrobial Resistance; (Section 3 (c) relating to authorities over antimicrobial drug data collection.) HR 3519/S 1709 Veterninary Services Investment Act; (Support of legislation.) HR 1427 Promoting Innovation and Access to Life-Saving Medicine Act; (all relating to follow-on biologics.) S 1142 The "Informed Health Care Decision Making" Act of 2009; (Sections pertaining to comparative effectiveness.) HR 1321 Healthy Americans Act; (Relating to Medicare) Senate Finance Committee Chairman's Mark, America's Healthy Future Act of 2009 (All provisions.) HR 3590 Patient Protection and Affordable Care Act; (Sections relating to health insurance and drugs, all provsions relating to healthcare; all provisions related to competitive acquisition for durable medical equipment and prosthetics, orthotics, and supplies.).) HR 3962 Affordable Health Care for America Act; (Sections relating to health insurance and drugs; provisions related to subtitles A, B, C, and D.) HR 4872 The Health Care and Education Afforability Reconciliation Act; (All provisions dealing with phramaceuticals and medical devices.) S 1796 America's Healthy Future Act of 2009; (Provisions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) S 1679 Affordable Health Choices Act; (Provsions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) HR 3200 America's Affordable Health Choices Act of 2009; (Provisions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) HR 3790 To Amend Title XVIII of the Social Security Act to repeal the Medicare competitive aquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS); (All provisions related to competitive acquistionf for durable medical equipment and prosthetics, orthotcs, and supplies.)

Client expense: $1,198,200 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1679 Kennedy Health Care Reform Bill Senate Finance Committee Health Care Reform Bill H.R. 3200 Tri-Committee Health Care Reform Bill S. 1213, H.R. 2502 Comparative Effectiveness Research S. 1142 - Informed Health Care Decision Making Act H.R. 3276 - Nuclear Medicine and Research Legislation Medical Device Tax H.R. 3590 - Patient Protection and Affordable Care Act H.R. 4872 - Health Care and Education Reconciliation Act of 2010 H.R. 4956 - Stop Oxy Abuse Act of 2010

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346/ S. 540, "Medical Device Safety Act of 2009", regarding all provisions. - Issues relating to the McNeil recall of over the counter medications.

Client expense: $1,150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

HR 1549/S 619 To amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases; (Title II General provisions in the bill.) HR 2749 Food Safety Enhancement Act of 2009 to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes; (Title 1 Food Safety. Monitoring food safety provisions.) HR 2400 Strategies to Address Antimicrobial Resistance; (Section 3(c) relating to authorities over Antimicrobial drug data collection.) HR 3519/S 1709 Veterinary Services Investment Act; (Support legislation.) HR 6228/S 593 The Ban Poisonous Additives Act of 2009: A bill to ban the use of Bisphenol-A in food containers, and for other purposes; (All provisions pertaining to the ban of food contact applications and the science used to support the ban on Bisphenol-A containing products.) S 753 The Children's Safe Chemical Act: A ban on food contact materials for children and infants (3 years and under); (All provisions and amendments pertaining to the ban and the testing are relevant.) HR 4341 Bisphenol-A Consumer Information Act 2009: A bill to amend the Food Drug and Cosmetic Act to require a warning on the label of any food container that is composed, in whole or in part of Bisphenol-A or could release Bisphenol-a into the food; (All provisions relating to the science, restrictions on use and applications of Bisphenol-A in food applications.) HR 2749 Food Safety Enhancement Act of 2009, a reform of the law on food safety protection; (All provisions pertaining to the FDA mandate to make a safety determination on BPA before the end of the year.) HR 3962 Affordable Health Care for America Act; (Provisions related to subtitle, A,B,C, and D.) HR 4213 "American Jobs and Closing Tax Loopholes Act of 2010" (Sections pertaining to AMP, and allocation systems; all provisions related to pharmaceuticals and medical devices) S.Amdt 4369 to HR 4213 In the Nature of a substitute; (Sections pertaining to AMP, and allocation systems.) HR 1427 Promoting Innovation and Access to Life-Saving Medicine Act; (All relating to follow on biologics.) S 1142 the "Informed Health Care Decisions Making Act of 2009; (sections pertaining to comparative effectiveness.) HR 1321 Healthy Americans Act; (Relating to Medicare) HR 3590 Patient Protection and Affordable Care Act; (Sections relating to health insurance and drugs; All provisions relating to healthcare.) HR 3962 Affordable Health Care for America Act; (Sections relating to health insurance and drugs; All provisions related to pharmaceuticals and medical devices.) HR 4899 Making Emergency Supplemental Appropriations for Fiscal Year 2010; (All provisions related to pharmaceuticals and medical devices.)

Client expense: $934,670 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S.1213 - Patient Centered Outcomes Research Act- issues regarding all provisions; S.1142 - Informed Health Care Decision Making Act- issues regarding all provisions; Issues related to FDA 510(K) legislative changes; S.1679 - Affordable Health Choice Act- issues related comparative effectiveness & physicians sunshine; H.R. 3590 - Patient Protection and Affordable Care Act of 2009 - issues related comparative effectiveness & physicians sunshine and medical device tax; S. 1796 - "The Americas Healthy Future Act of 2009"- issues related to comparative effectiveness, physicians sunshine and medical device fee; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010- issues related to comparative effectiveness, physicians sunshine and medical device fee; Issues relating to the medical device tax/fee in general;

Client expense: $490,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions.

Client expense: $2,110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

HR 6228/S 593 the Ban Poisonous act of 2009, a bill to ban the use of Bisphenol-A in food containers, and for other purposes; (All provisions pertaining to the ban of food contact applications and the science used to support the ban on Bisphenol-A containing products.) S 753 The Children's Safe Chemical Act, a ban on food contact materials for children and infants (3 years and under); (All provisions and amendments pertaining to the ban and the testing are relevant.) HR 4341 Bisphenol-A Consumer Information Act 2009, a bill to amend the Food, Drug, and Cosmetic Act to require a warning on the lable of any food container that is composed, in whole or in part, of Bisphenol-A or could release Bisphenol-A into the food; (All provisions relating to the science, restrictions on use and applications of Bisphenol-A in food applications.) HR 2749 Food Safety Enhancement Act of 2009, a reform of the law on food safety protection; (All provisions pertaining to the FDA mandate to make a safety determination on BPA before the end of the year.) HR 1549/S 619 To amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal disease; (Title II. General provisions in the bill.) HR 2749 Food Safety Enhancement Act of 2009 To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other puposes; (Title I food Safety,; Monitoring food safety provisions.) HR 2400 Strategies to Address Antimicrobial Resistance; (Section 3 (c) relating to authorities over antimicrobial drug data collection.) HR 3519/S 1709 Veterninary Services Investment Act; (Support of legislation.) HR 1427 Promoting Innovation and Access to Life-Saving Medicine Act; (all relating to follow-on biologics.) S 1142 The "Informed Health Care Decision Making" Act of 2009; (Sections pertaining to comparative effectiveness.) HR 1321 Healthy Americans Act; (Relating to Medicare) Senate Finance Committee Chairman's Mark, America's Healthy Future Act of 2009 (All provisions.) HR 3590 Patient Protection and Affordable Care Act; (Sections relating to health insurance and drugs, all provsions relating to healthcare.) HR 3962 Affordable Health Care for America Act; (Sections relating to health insurance and drugs; provisions related to subtitles A, B, C, and D.) HR 4872 The Health Care and Education Afforability Reconciliation Act; (All provisions dealing with phramaceuticals and medical devices.) S 1796 America's Healthy Future Act of 2009; (Provisions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) S 1679 Affordable Health Choices Act; (Provsions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) HR 3200 America's Affordable Health Choices Act of 2009; (Provisions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.)

Client expense: $1,198,200 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1679 Kennedy Health Care Reform Bill Senate Finance Committee Health Care Reform Bill H.R. 3200 Tri-Committee Health Care Reform Bill S. 1213, H.R. 2502 Comparative Effectiveness Research S. 1142 - Informed Health Care Decision Making Act H.R. 3276 - Nuclear Medicine and Research Legislation Medical Device Safety Act of 2009 Medical Device Tax Bariatric Surgery H.R. 3590 - Patient Protection and Affordable Care Act H.R. 4872 - Health Care and Education Reconciliation Act of 2010 H.R. 1191/S.1336 - Safe Drug Disposal Act of 2009 H.R. 4956 - Stop Oxy Abuse Act of 2010

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S. 1213 - Patient Centered Outcomes Research Act; H.R. 2502 - Comparative Effective Research Act of 2009; S. 1142 - Informed Health Care Decision Making Act. S. 1679 - Affordable Health Choice Act; H.R. 3590 - Patient Protection and Affordable Care Act of 2009; H.R. 3962 - Affordable Healthcare for American Act; S. 1796 - "The Americas Healthy Future Act of 2009"; Issues relating to the medical device tax/fee; Senate Finance Committee Healthcare Reform Bill; H.R. 4872 - The Healthcare & Education Affordability Reconciliation Act of 2010.

Client expense: $475,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

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. 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, health reform fee and 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, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues 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. 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 Health and environment issues User fee issues

Client expense: $7,010,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), 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), White House Office

H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. Provisions within the health care reform bills with an emphasis on physician disclosure, comparative effectiveness research, pain research, Medicare secondary payer, bundling, gainsharing, medical device registry, and medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT)

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT)

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S. 1213 - Patient Centered Outcomes Research Act; H.R. 2502-Comparative Effectiveness Research Act of 2009; S. 1142 Informed Health Care Decision Making Act. Tri-Committee healthcare reform Proposal; (H.R. 3200, America's Affordable Health Choice Act of 2009) S. 440/H.R. 1346 - Medical Devices Safety Act of 2009; S. 1679 Affordable Health Choice Act; H.R. 3590 Patient Protection and Affordable Care Act of 2009; H.R. 3962 Affordable Healthcare for American Act; S. 1796 "The Americas Healthy Future Act of 2009"; Issues relating to the medical device tax/fee; Senate Finance Committee Healthcare Reform Bill.

Client expense: $450,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

S. 1679 Kennedy Health Care Reform Bill Senate Finance Committee Health Care Reform Bill H.R. 3200 Tri-Committee Health Care Reform Bill S. 1213, H.R. 2502 Comparative Effectiveness Research S. 1142 Informed Health Care Decision Making Act H.R. 3276, Nuclear Medicine and Research Legislation Medical Device Safety Act of 2009 Medical Device Tax Bariatric Surgery H.R. 3590, Patient Protection and Affordable Care Act

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

H.R. 444, 340B Program Improvement 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. 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. 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, America's Health Future Act of 2009: comparative effectiveness, importation, health reform issues generally

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6228/S 593 The Ban Poisonous Act of 2009, A bill to ban the use of Bisphenol-A in food containers, and for other purposes; (all provisions pertaining to the ban of food contact applications and the science used to support the ban on Bisphenol-A containing products.) S 753 The Children's Safe Chemical Act a ban on food contact materials for children and infants (3 years and under); (All provisions and amendments pertaining to the ban and the testing are relevant.) HR 4341 Bisphenol -A Consumer Information Act of 2009, a bill to amend the Food Drug and Cosmetic Act to require a warning on the label of any food container that is composed, in whole or in part, of Bisphenol-A or could release Bisphenol A into the food; (All provisions relating to the science, restrictions on use and applications of Bisphenol-A in food applications.) HR 2749 Food Safety Enhancement Act of 2009, a reform of the law on food safety protection; (All provisions pertaining to the FDA mandate to make a safety determination on BPA before the end of the year.) HR 1427 Promoting Innovation and Access to Life-Saving Medicine Act; (All provisions relating to follow on biologics.) S 1142 The "Informed Health Care Decisions Making Act of 2009; (Sections pertaining to comparative effectiveness.) HR 1321 Healty Americans Act; (Provisions relating to Medicare.) Senate Finance Committee Chairman's Mark, America's Healthy Future Act of 2009; (All provisions.) HR 3590 Patient Protection and Affordable Care Act; (Sections relating to health insurance and drugs, all provisions relating to healthcare) HR 3962 Affordable Health Care for America Act; (Sections relating to health insurance and drugs, provisions related to subtitles A,B, C and D.) Senate: Patient Protection & Affordable Care Act; (All provisions relating to health care.) S 1796 America's Healthy Future Act of 2009; (Provisions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) S 1679 Affordable Health Choices Act; (Provisions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) HR 3200 America's Affordable Health Choices Act of 2009; (Provisions relating to medical device excise tax, medicare reimbursement rates for medical imaging, comparative effectiveness research.) HR 1549/S 619 the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases; (Title II. General provisons in the bill.) HR 2749 Food Safety Enhancement Act of 2009 To amend the Federal Food, Drug, and cosmetic act to improve the safety of food in the global market, and for other purposes.) HR 3519/S 1709 Veterinary Services Investment Act (Support for legislation.) HR 2400 Strategies to Address Antimicrobial Resistance; (Section 3(c) relating to authorities over antimicrobial drug data collection.) S 510 Food Safety Modernization Act; (Provisions relating to strategy for comments.)

Client expense: $1,570,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions.

Client expense: $1,640,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

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

Client expense: $6,300,520 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S. 1213 - Patient Centered Outcomes Research Act; H.R. 2502-Comparative Effectiveness Research Act of 2009; S. 1142 Informed Health Care Decision Making Act. Tri-Committee healthcare reform Proposal; (H.R. 3200, America's Affordable Health Choice Act of 2009) S. 440/H.R. 1346 - Medical Devices Safety Act of 2009; S. 1679 Affordable Health Choice Act; H.R. 3590 Patient Protection and Affordable Care Act of 2009; H.R. 3962 Affordable Healthcare for American Act; S. 1796 "The Americas Healthy Future Act of 2009"; Issues relating to the medical device tax/fee; Senate Finance Committee Healthcare Reform Bill.

Client expense: $450,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 3590, the Patient Protection and Affordable Care Act, the legislative vehicle used to pass Leader Reid's manager's amendment regarding health care reform on the Senate floor H.R. 3962, Affordable Health Care for America Act,to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes Other Senate and House Committee Health Reform bills with an emphasis on physician disclosure, comparative effectiveness research, pain research, Medicare secondary payer, bundling, gainsharing, medical device registry, and medical device tax. Medicare Secondary Payer provision, which was included in Ways and Means Chairman's Mark for HR 3200, the America's Affordable Health Choices Act, that would have increased exposure to liability for suppliers S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity &Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1390, the Defense Authorization Bill, provisions related to pain management which would require a comprehensive pain care policy on pain management by the military health care system

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S. 1213 - Patient Centered Outcomes Research Act; H.R. 2502- Comparative Effectiveness Research Act of 2009; S. 1142 -Informed Health Care Decision Making Act. Senate Finance Committee Healthcare Reform Proposal-medical device tax; Tri-Committee Healthcare Reform Proposal; (H.R. 3200, America's Affordable Health Choice Act of 2009) S. 440/H.R.1346- Medical Device Safety Act of 2009; H.R. 2976/S. 1312- Medicare Safe Needles Disposal Coverage Act of 2009; S.1679 Affordable Health Choice Act.

Client expense: $430,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

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

Client expense: $3,950,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions.

Client expense: $1,660,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

S.- America's Healthy Future Act. (Finance Committee Version); S. 1679- The Affordable Health Choices Act; H.R. 3200: America's Affordable Health Choices Act of 2009; 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. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness; 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. 1142, Informed Health Care Decision Making Act: drug labeling; S. 1213, Patient-Centered Outcomes and 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 pathway for follow-on biologics, 340B program issues; H.R. 759, Food and Drug Administration Globalization Act, 2009: import safety; S. 623, Access to Life-Saving Medicine Act; Follow-on biologics

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1679 Kennedy Health Care Reform Bill Senate Finance Committee Health Care Reform Bill H.R. 3200 Tri-Committee Health Care Reform Bill S. 1213, H.R. 2502 Comparative Effectiveness Research S. 1142 Informed Health Care Decision Making Act H.R. 3276 Nuclear Medicine and Research Legislation Medical Device Safety Act of 2009 Medical Device Tax Bariatric Surgery

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

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

Client expense: $6,790,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising Medicare Secondary Payer provision, which was included in Ways and Means Chairman's Mark for HR 3200, the America's Affordable Health Choices Act, that would have increased exposure to liability for suppliers, including device manufacturers

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S.1679, the Affordable Health Choices Act, to provide affordable, quality health care for all Americans H.R. 3200, America's Affordable Health Choices Act of 2009, to provide affordable, quality health care for all Americans Other Senate and House Committee Health Reform bills with an emphasis on physician disclosure, comparative effectiveness research, pain research, medicare secondary payer, bundling, gainsharing, medical device registry, and medical device tax. Medicare Secondary Payer provision, which was included in Ways and Means Chairman's Mark for HR 3200, the America's Affordable Health Choices Act, that would have increased exposure to liability for suppliers S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity &Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1390, the Defense Authorization Bill, provisions related to pain management which would require a comprehensive pain care policy on pain management by the military health care system

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Supported all provisions unless indicated otherwise: S. 683, Community Choice Act of 2009 S. 1679, Affordable Health Care Choices Act S.979/H.R. 2360, Small Business Health Options Program (SHOP) Act of 2009 Supported all provisions unless indicated otherwise: Senate Finance Committee White Paper Expanding Health Care Coverage: Proposals to Provide Affordable Coverage - supported/recommended provisions to end two-year wait for Medicare; expand Medicaid; provide adequate benefits packages for low- and moderate-income people; include caps on out-of-pocket costs; protect low-income Medicare beneficiaries; and address health disparities No bill number, Senate Finance Committee's America's Healthy Future Act:supported/recommended provisions to improve/include consumer protections; include caps on out-of-pocket costs; include limits on premium costs; provide adequate benefits for low- and moderate-income people; protect low-income Medicare beneficiaries; align Medicaid coverage with subsidies; increase subsidies and make coverage affordable for low- and moderate-income families; end age rating and prohibit workplace wellness; support provisions regarding increasing drug rebate; and include EPSDT for children S. 1142, Informed Health Care Decision-Making Act S. Con. Res. 32, A bill expressing the Sense of Congress on health care reform legislation S. 697/H.R. 1721, Community Living Assistance Services and Supports Act or CLASS Act S. 1050/H.R. 2427, Informed Consumer Choices in Health Care Act of 2009 S. 1152/H.R. 2460, Healthy Families Act H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009 H.R. 2427, Informed Consumer Choices in Health Care Act of 2009 H.R. 2744, Equal Rights for Helath Care Act - Title 42 H.R. 3090, Health Equity and Accountability Act of 2009 H.R. 3200, America's Affordable Health Choices Act of 2009

Client expense: $30,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3200: America's Affordable Health Choices Act of 2009 Americas Healthy Future Act of 2009 (Senate Finance legislation) The Affordable Health Choices Act (Senate HELP Committee Legislation) H.R.2917 : To amend the Internal Revenue Code of 1986 to deny any deduction for advertising prescription drugs. S.1142 : A bill to amend the Federal Food, Drug, and Cosmetic Act

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to healthcare, healthcare reimbursement, and healthcare reform; S. 1213 - Patient Centered Outcomes Research Act; H.R. 2502- Comparative Effectiveness Research Act of 2009; S. 1142 -Informed Health Care Decision Making Act. Kennedy HELP Committee Healthcare Reform Proposal; Senate Finance Committee Healthcare Reform Proposal; Tri-Committee Healthcare Reform Proposal; S. 440/H.R.1346- Medical Device Safety Act of 2009; H.R. 2976/S. 1312- Medicare Safe Needles Disposal Coverage Act of 2009.

Client expense: $510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

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

Client expense: $6,150,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office