Drug and Device Accountability Act of 2009

H. R. 759, The Food and Drug Administration Globalization Act of 2009; S.882, Drug and Device Accountability Act of 2009; issues regarding the US Preventative Task Force; policy matters related to medical radiation; policy matters related to the FDA approval process for devices; H.R. 3652 and S.3737, the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging & Radiation Therapy Act of 2009; medical device user fees

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Implementation of comprehensive health care reform including H.R.4872, The Reconciliation Act of 2010 & H.R.3590, The Patient Protection & Affordable Care Act, Medical Device Safety Act of 2009; H.R.759, Food & Drug Globalization Act of 2009 & S.882, Drug and Device Accountability Act of 2009; comparative effectiveness research; policy matters related to medical radiation; policy matters related to the FDA approval process for devices; medical device user fee programs

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

HR 759 Food and Drug Administration Globalization Act of 2009, S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 and General Importation issues, H.R. 2749 Food Safety Safety Enhancement Act, S. 882 The Drug and Device Accountability Act of 2009, Prescription Drug User Fee Act of 2012 preparation, general pedigree and chain drug supply issues, HR 4678 Foreign Manufacturers Legal Accountiblity Act; H.R. 6543 The Drug Safety Enhancement Act

Client expense: $550,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE, Treasury, Dept of

H.R. 694, to extend temporarily the 18-month period of continuation coverage under group health plans required under COBRA continuation coverage provisions so as to provide for a total period of continuation coverage of up to 24 months. H.R. 3468, to amend the Internal Revenue Code of 1986, the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to promote the use of prevention and wellness programs. H.R. 3472, to provide for health insurance coverage premium discounts for healthy behavior and improvements toward healthy behavior. H.R. 3144, to amend the Public Health Service Act to promote obesity prevention, including proper nutrition and exercise. H.R. 3200, to provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 3261, to permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests. H.R. 3590, the Patient Protection and Affordable Care Act. H.R. 3688, to encourage programs of health promotion or disease prevention. H.R. 3830, to direct the secretary of health and human services to develop an individual chronic disease prevention and wellness achievement matrix. H.R. 3962, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 5430, to direct the secretary of agriculture to award grants to eligible entities for projects that leverage community resources and support student access to physical activity, nutrition education, and nutritious foods during the regular school calendar. H.R. 5431, to amend section 17 of the Richard B. Russell National School Lunch Act to promote health and wellness in child care. H.R. 5440, to secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments. S. 4, to guarantee affordable, quality health coverage for all Americans, and for other purposes. S. 882, 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. S. 1640. A bill to amend title XVIII of the Social Security Act to provide coverage of intensive lifestyle treatment S. 1796, to provide affordable, quality health care for all Americans and reduce the growth in health care spending. S. 2766, to provide for the coverage of medically necessary food under federal health programs and private health insurance. S. 2942, to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology program. S. 3446, to amend the Child Nutrition Act of 1966 to advance the health and wellbeing of schoolchildren in the United States through technical assistance, training, and support for healthy school foods, local wellness policies, and nutrition promotion and education.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Budget Reconcilliation, Implementation of Health Care Reform, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, 340B Drug Pricing Program, and generic drugs S.501 - Fair Prescription Drug Competition Act, all provisions S.882 - Drug and Device Accountability Act of 2009, Title I Subtitle A, B, C, and D and Title II H.R. 759 - Food and Drug Administration Globalization Act of 2009, Title II S.525, S.1232, and H.R.1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act, Title VII - Improving Access to Innovative Medical Therapies H.R.4872 - Reconciliation Bill, Section 1101, Closing the Medicare Prescription Drug "Donut Hole" H.R.4213 - American Jobs and Closing Tax Loopholes Act H.R.4899 - War Supplemental S.1315 - Drug Price Competition Act of 2009

Client expense: $342,888 · Firm income: Not reported

Government targets: 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

S.882, Drug and Device Accountability Act of 2009 and HR 759, Food and Drug Administration Globalization Act of 2009, regulation of medical gas product manufacturing.

Client expense: $230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1020, HR 1346, HR 1508, HR 2975, HR 3054, HR 3459, HR 4113, HR 5503, HR 5676, S 1734, S 301, S 386, S 458, S 537, S 540, S 657, S 882, S 931

Client expense: $810,000 · Firm income: Not reported

Government targets: Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

Regulation of medical gas product manufacturing (H.R. 759, S.882).

Client expense: Not reported · Firm income: $40,000

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)

H.R. 694, to extend temporarily the 18-month period of continuation coverage under group health plans required under COBRA continuation coverage provisions so as to provide for a total period of continuation coverage of up to 24 months. H.R. 3468, to amend the Internal Revenue Code of 1986, the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to promote the use of prevention and wellness programs. H.R. 3472, to provide for health insurance coverage premium discounts for healthy behavior and improvements toward healthy behavior. H.R. 3144, to amend the Public Health Service Act to promote obesity prevention, including proper nutrition and exercise. H.R. 3200, to provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 3261, to permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests. H.R. 3590, the Patient Protection and Affordable Care Act. H.R. 3688, to encourage programs of health promotion or disease prevention. H.R. 3830, to direct the secretary of health and human services to develop an individual chronic disease prevention and wellness achievement matrix. H.R. 3962, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 5430, to direct the secretary of agriculture to award grants to eligible entities for projects that leverage community resources and support student access to physical activity, nutrition education, and nutritious foods during the regular school calendar. H.R. 5431, to amend section 17 of the Richard B. Russell National School Lunch Act to promote health and wellness in child care. H.R. 5440, to secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments. S. 4, to guarantee affordable, quality health coverage for all Americans, and for other purposes. S. 882, 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. S. 1640. A bill to amend title XVIII of the Social Security Act to provide coverage of intensive lifestyle treatment S. 1796, to provide affordable, quality health care for all Americans and reduce the growth in health care spending. S. 2766, to provide for the coverage of medically necessary food under federal health programs and private health insurance. S. 2942, to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology program. S. 3446, to amend the Child Nutrition Act of 1966 to advance the health and wellbeing of schoolchildren in the United States through technical assistance, training, and support for healthy school foods, local wellness policies, and nutrition promotion and education.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

HR 759 Food and Drug Administration Globalization Act of 2009; S. 882 The Drug and Device Accountability Act of 2009; S. 882 The Drug and Device Accountability Act of 2009; H.R.5740, To provide for the mandatory recall of adulterated or misbranded drugs.

Client expense: Not reported · Firm income: $65,000

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

H.R. 1392, to amend Title XVIII of the Social Security Act S. 1221, to amend Title XVIII of the Social Security Act H.R. 759, Food and Drug Administration Globalization Act of 2009 S. 525, a bill to amend the Federal Food, Drug and Cosmetic Act S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 882, Drug and Device Accountability Act of 2009 S. 301, to amend the Title XI of the Social Security Act Health information technology issues

Client expense: $110,000 · 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), SENATE

H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 S. 1796 America's Affordable Health Choices Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act America's Healthy Future Act of 2009 H.R. 3974 Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 2596 No Child Left Unimmunized Against Influenza Act of 2009 S. 2964 Strengthening Program Integrity and Accountability in Health Care Act S. 3002 Dietary Supplement Safety Act of 2010 H.R. 4872 Health Care and Education Affordability Reconciliation Act H.R. 5516 Access to Appropriate Immunizations for Veterans Act of 2010 H.R. 5503 Securing Protections for the Injured from Limitations on Liability Act H.R. 4899 Supplemental Appropriations Act, 2010 - provisions pertaining to Bio-defense funding and the Ryan White CARE Act S. 3686 Fiscal Year 2011 Labor HHS Appropriations, all provisions pertaining to the Ryan White CARE Act as well as related House Fiscal Year 2011 Labor-HHS Appropriations Ryan White CARE Act provisions H.R. 5923 Patients Freedom to Choose Act, reimbursement of OTC drugs under Flexible and Health Savings accounts S. 3673 Patients Freedom to Choose Act, reimbursement of OTC drugs under Flexible and Health Savings accounts S. 3397 Secure and Responsible Drug Disposal Act, drug safety

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.882, Drug and Device Accountability Act of 2009 and HR 759, Food and Drug Administration Globalization Act of 2009, regulation of medical gas product manufacturing.

Client expense: $240,000 · Firm income: Not reported

Government targets: Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE

H.R.759, The Food and Drug Administration Globalization Act of 2009; S.882, Drug and Device Accountability Act of 2009; issues regarding the US Preventative Task Force recommendations on Breast Cancer Screening; policy matters related to medical radiation; policy matters related to the FDA approval process for devices; H.R.3652and S.3737, the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging & Radiation Therapy Act of 2009.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Implementation of comprehensive health care reform including H.R.4872, The Reconciliation Act of 2010 & H.R.3590, The Patient Protection & Affordable Care Act, Medical Device Safety Act of 2009; H.R.759, Food & Drug Globalization Act of 2009 & S.882, Drug and Device Accountability Act of 2009; comparative effectiveness research; policy matters related to medical radiation; policy matters related to the FDA approval process for devices; issues relating to wound healing and tissue regeration medical technology

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

Medical Research Antibiotic Resistance issues P.L. 111-148 Patient Protection and Affordable Care Act (PPACA) - funding of PPACA programs and provisions P.L. 111-152 Health Care and Education Reconciliation Act of 2010 PDUFA Reauthorization - The Prescription Drug User Fee Act is due for reauthorization in 2012 and discussions in anticipation of that reauthorization have begun H.R. 5712 Health Care Technical Corrections - This bill would repeal a provision of the health care reform bill that would extend debarring to all parts of a corporate family when any part of that corporate family settles an investigation of misconduct with the government HR 759 Food and Drug Administration Globalization Act of 2009 S. 882 The Drug and Device Accountability Act of 2009 H.R.5740 - To provide for the mandatory recall of adulterated or misbranded drugs S. 369 Preserve Access to Affordable Generics Act H.R. 1706 Protecting Consumer Access to Generic Drugs Act H.R. 573 Fair Prescription Drug Competition Act S. 501 Fair Prescription Drug Competition Act H.R. 6331 Generating Antibiotic Incentives Now Act of 2010 H.R. 3081 Continuing Appropriations Act, 2011 (340B Provisions) - changes to the 340B Drug Discount Program. S. 11 To restore the application of the 340B drug discount program to orphan drugs with respect to childrens hospitals

Client expense: $220,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

HR 1020, HR 1346, HR 1508, HR 2975, HR 3054, HR 3459, HR 4113, HR 5503, HR 5676, S 1734, S 301, S 386, S 458, S 537, S 540, S 657, S 882, S 931

Client expense: $1,170,000 · Firm income: Not reported

Government targets: Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), 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. - 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

Issues related to methamphetamine precursor chemicals HR 759, HR 5740, S 882, S 3690 - regarding the manufacturing and importation of OTC drugs and the mandatory recall authority of the FDA.

Client expense: $736,734 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Office of Natl Drug Control Policy (NDCP), SENATE

H.R. 1392, to amend Title XVIII of the Social Security Act S. 1221, to amend Title XVIII of the Social Security Act H.R. 759, Food and Drug Administration Globalization Act of 2009 S. 525, a bill to amend the Federal Food, Drug and Cosmetic Act S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 882, Drug and Device Accountability Act of 2009 S. 301, to amend the Title XI of the Social Security Act Health information technology issues

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

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

HR 759 Food and Drug Administration Globalization Act of 2009, S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 and General Importation issues, H.R. 2749 Food Safety Safety Enhancement Act, S. 882 The Drug and Device Accountability Act of 2009, Prescription Drug User Fee Act of 2012 preparation, general pedigree and chain drug supply issues, HR 4678 Foreign Manufacturers Legal Accountiblity Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

Budget Reconcilliation, Implementation of Health Care Reform, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Authorized Generics, Prescription Drug Importation/Re-Importation, 340B Drug Pricing Program, and generic drugs S.501 - Fair Prescription Drug Competition Act, all provisions S.882 - Drug and Device Accountability Act of 2009, Title I Subtitle A, B, C, and D and Title II H.R. 759 - Food and Drug Administration Globalization Act of 2009, Title II S.525, S.1232, and H.R.1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act, Title VII - Improving Access to Innovative Medical Therapies H.R.4872 - Reconciliation Bill, Section 1101, Closing the Medicare Prescription Drug "Donut Hole" H.R.4213 - American Jobs and Closing Tax Loopholes Act H.R.4899 - War Supplemental S.1315 - Drug Price Competition Act of 2009

Client expense: $372,750 · Firm income: Not reported

Government targets: 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Food and Drug Import Safety Act, provision affecting medical isotope import requirements Senate Drug and Safety Accountability House Energy and Commerce Drug Administration discussion draft S. 510, FDA Food Safety Modernization Act S. 882, Drug and Device Accountability Act of 2009 HR 759, Food and Drug Administration Globalization Act of 2009 H.R. 2749, Food Safety Enhancement Act of 2009

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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: $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)

Regulation of medical gas product manufacturing (H.R. 759, S.882).

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 694, to extend temporarily the 18-month period of continuation coverage under group health plans required under COBRA continuation coverage provisions so as to provide for a total period of continuation coverage of up to 24 months. H.R. 3468, to amend the Internal Revenue Code of 1986, the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to promote the use of prevention and wellness programs. H.R. 3472, to provide for health insurance coverage premium discounts for healthy behavior and improvements toward healthy behavior. H.R. 3144, to amend the Public Health Service Act to promote obesity prevention, including proper nutrition and exercise. H.R. 3200, to provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 3261, to permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests. H.R. 3688, to encourage programs of health promotion or disease prevention. H.R. 3830, to direct the secretary of health and human services to develop an individual chronic disease prevention and wellness achievement matrix. H.R. 3962, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590, the Patient Protection and Affordable Care Act. H.R. 3830, to direct the secretary of health and human services to develop an individual chronic disease prevention and wellness achievement matrix. H.R. 3962, to provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 5430, to direct the secretary of agriculture to award grants to eligible entities for projects that leverage community resources and support student access to physical activity, nutrition education, and nutritious foods during the regular school calendar. H.R. 5431, to amend section 17 of the Richard B. Russell National School Lunch Act to promote health and wellness in child care. H.R. 5440, to secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments. S. 4, to guarantee affordable, quality health coverage for all Americans, and for other purposes. S. 882, 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. S. 1640. A bill to amend title XVIII of the Social Security Act to provide coverage of intensive lifestyle treatment S. 1796, to provide affordable, quality health care for all Americans and reduce the growth in health care spending. S. 2766, to provide for the coverage of medically necessary food under federal health programs and private health insurance. S. 2942, to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology program. S. 3446, to amend the Child Nutrition Act of 1966 to advance the health and wellbeing of schoolchildren in the United States through technical assistance, training, and support for healthy school foods, local wellness policies, and nutrition promotion and education.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 3590, Patient Protection and Affordable Care Act H.R. 4872, Health Care and Education Reconciliation Act of 2010 H.R. 1392, To amend Title XVIII of the Social Security Act S. 1221, To amend Title XVIII of the Social Security Act H.R. 759, Food and Drug Administration Globalization Act of 2009 S. 525, A bill to amend the Federal Food, Drug and Cosmetic Act S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 882, Drug and Device Accountability Act of 2009 S. 301, To amend Title XI of the Social Security Act Health information technology issues

Client expense: $240,000 · Firm income: Not reported

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

S.80 - Pharmaceutical Market Access Act, 1/09 S. 501 - Fair prescription Drug Competition Act, 3/09 S. 882 - Drug and Device Accountability Act H.R. 573 - act to prohibit the marketing of authorized generic drugs, 1/09 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicines Act, 3/09 H.R. 1548 - Pathway for Biosimilars Act, 3/09 H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09

Client expense: $2,250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Generic Biologics, Health Care Reform, Budget Reconcilliation, Implementation of Health Care Reform Bill, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Authorized Generics, Prescription Drug Importation/Re-Importation, 340B Drug Pricing Program, and generic drugs H.R.1427 and S.726 - Promoting Innovation and Access to Life-Saving Medicines Act, all provisions H.R.1548 - Pathway for Biosimilars Act, all provisions H.R.573, all provisions S.501 - Fair Prescription Drug Competition Act, all provisions S.882 - Drug and Device Accountability Act of 2009, Title I Subtitle A, B, C, and D and Title II H.R. 759 - Food and Drug Administration Globalization Act of 2009, Title II S.525, S.1232, and H.R.1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act, Title VII - Improving Access to Innovative Medical Therapies; Section 10609 Generic Drug Labeling H.R.3962 - Affordable Health Care for America Act, Title I Subtitle B Part 3 Section 1149A - Payment for Biosimilar Biological Products; Title V Subtitle C Part 2 - Biosimilars H.R.4872 - Reconciliation Bill, Section 1101, Closing the Medicare Prescription Drug "Donut Hole" H.R.4213 - American Jobs and Closing Tax Loopholes Act H.R.4899 - War Supplemental Bill

Client expense: $463,244 · Firm income: Not reported

Government targets: 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 S. 1796 America's Affordable Health Choices Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act America's Healthy Future Act of 2009 H.R. 3974 Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 2596 No Child Left Unimmunized Against Influenza Act of 2009 S. 2964 Strengthening Program Integrity and Accountability in Health Care Act S. 3002 Dietary Supplement Safety Act of 2010 H.R. 4872 Health Care and Education Affordability Reconciliation Act H.R. 5516 Access to Appropriate Immunizations for Veterans Act of 2010 H.R. 5503 Securing Protections for the Injured from Limitations on Liability Act H.R. 4899 Supplemental Appropriations Act, 2010 - provisions pertaining to Bio-defense funding and the Ryan White CARE Act Fiscal Year 2011 Labor, Health and Human Services Appropriations - provisions pertaining to the Ryan White CARE Act

Client expense: $1,210,000 · 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. - 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

H.R.759, Food and Drug Administration Globalization Act of 2009, Issues related to import safety S.882, Drug and Device Accountability Act of 2009, Issues related to import safety S.540, Medical Device Safety Act of 2009, Issues related to federal preemption Issues related to pandemic planning Issues related to FDA regulation of medical devices Issues related to pedigree legislation

Client expense: $100,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Food and Drug Import Safety Act, provision affecting medical isotope import requirements Senate Drug and Safety Accountability House Energy and Commerce Drug Administration discussion draft S. 510, FDA Food Safety Modernization Act S. 882, Drug and Device Accountability Act of 2009 HR 759, Food and Drug Administration Globalization Act of 2009 H.R. 2749, Food Safety Enhancement Act of 2009

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

HR 4816, the Food and Drug Administration Improvement Act of 2010, provisions related to providing the Food and Drug Administration with resources to ensure safety of drugs imported into the US from foreign countries. HR 759, the Food and Drug Administration Globalization Act of 2009, provisions to expand FDA's authority to inspect foreign drug facilities. S. 882, the Drug and Device Accountability Act of 2009, provisions to expand FDA's authority to inspect foreign drug facilities.

Client expense: $78,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 759, The Food and Drug Administration Globalization Act of 2009; S.882, Drug and Device Accountability Act of 2009; issues regarding the US Preventative Task Force recommendations on Breast Cancer Screening; policy matters related to medical radiation; policy matters related to the FDA approval process for devices; H.R.3652, the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging & Radiation Therapy Act of 2009.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Implementation of comprehensive health care reform including H.R.4872,The Reconciliation Act of 2010 &H.R.3590, The Patient Protection & Affordable Care Act, Medical Device Safety Act of 2009; H.R.759, Food & Drug Globalization Act of 2009 & S.882, Drug and Device Accountability Act of 2009; comparative effectiveness research; policy matters related to medical radiation; policy matters related to the FDA approval process for devices; issues relating to wound healing and tissue regeration medical technology

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

HR 1020, HR 1346, HR 1508, HR 2975, HR 3054, HR 3459, HR 4113, HR 5503, HR 5676, S 1734, S 301, S 386, S 458, S 837, S 540, S 657, S 882, S 931

Client expense: $1,490,000 · Firm income: Not reported

Government targets: Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

Issues related to methamphetamine precursor chemicals HR 759, S 882 - regarding the manufacturing and import of OTC drugs

Client expense: $1,687,444 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE

HR 759 Food and Drug Administration Globalization Act of 2009, S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 and General Importation issues, H.R. 2749 Food Safety Safety Enhancement Act, S. 882 The Drug and Device Accountability Act of 2009, Prescription Drug User Fee Act of 2012 preparation, general pedigree and chain drug supply issues

Client expense: $200,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

H.R. 3590, Patient Protection and Affordable Care Act H.R. 4872, Health Care and Education Reconciliation Act of 2010 H.R. 1392, To amend Title XVIII of the Social Security Act S. 1221, To amend Title XVIII of the Social Security Act H.R. 759, Food and Drug Administration Globalization Act of 2009 S. 525, A bill to amend the Federal Food, Drug and Cosmetic Act S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 882, Drug and Device Accountability Act of 2009 S. 301, To amend Title XI of the Social Security Act Health information technology issues

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

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

S.882, Drug and Device Accountability Act of 2009 and HR 759, Food and Drug Administration Globalization Act of 2009, regulation of medical gas product manufacturing; HR 3590, Patient Protection of Affordable Care Act, impact on our industry.

Client expense: $230,000 · Firm income: Not reported

Government targets: Energy, Dept of, 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

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)

Monitoring healthcare issues in House and Senate; S.882, Drug and Device Accountability Act of 2009. HR 3200, The America's Affordable Health Choices Act of 2009.

Client expense: Not reported · Firm income: $180,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE