Medical Device Safety Act of 2008

Lilly Ledbetter Fair Pay Act (H.R. 2831; Medical Devices Safety Acty (H.R. 6381 and S. 3398); State Secrets Security Act (S. 2533)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

-H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S.2274, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan", and for other purposes, regarding all provisions. -S.3409 "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.1378 "A bill 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. -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill 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. 1276, "Methamphetamine Production Prevention Act of 2008", 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. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; -S.2424, "A bill to ensure that all Americans have basic health literacy skills to function effectively as patients and health care consumers", regarding all provisions.

Client expense: $1,440,000 · Firm income: Not reported

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

S 631 - Remote Monitoring Access Act of 2007 - a bill to provide for coverage of remote patient management services for chronic health care conditions under the Medicare program. [Julie Cohen, Seth Radus, Brett Loper, Madeleine Smith] HR 1321/S 2404 - Medicaid Advanced Laboratory Diagnostics Act of 2007 - a bill to improve payments under the Medicare clinical laboratory fee schedule [Julie Cohen, Seth Radus, Brett Loper] S 736 - Laboratory Test Improvement Act [David Nexon] HR 1293/S 1338- Access to Medicare Imaging Act - a bill to provide for a 2-year moratorium on certain Medicare physician payment reductions for advanced diagnostic imaging service [Seth Radus, Madeleine Smith] HR 3162 - Children's Health and Medicare Protection Act of 2007 - a bill to extend and improve the children's health insurance program, to improve beneficiary protections under the Medicare, Medicaid, and the CHIP program. [Julie Cohen, Seth Radus, David Nexon] S 2029- Physician Payments Sunshine Act of 2007 - a bill to provide transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. [Seth Radus, Julie Cohen, Brett Loper, David Nexon] HR 5605 - Physician Payments Sunshine Act of 2008 - A bill to amendment title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP, and for other purposes [Julie Cohen, Seth Radus, David Nexon] S 2221 - Transparency in Medical Device Pricing Act of 2007 - a bill to provide for the reporting of sales price data for implantable medical devices [ Seth Radus, Julie Cohen, David Nexon, Brett Loper, Madeleine Smith, David Nexon] HR 3023 - Drug and Medical Device Company Gift Disclosure Act - a bill to require the manufacturers, and distributors of prescription drugs and medical devices to disclosre certain gifts provided in connection with detailing, promotional, or other marketing activities. [Seth Radus, Julie Cohen, David Nexon] HR 6381 - to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. [Seth Radus, Julie Cohen] S. 3010/HR 6331 - Medicare Improvements for Patients and Providers Act of 2008. A bill to amend title XVIII (medicare) of the Social Security Act (SSA) to provide for coverage of additional preventive services [Julie Cohen, Brett Loper, Seth Radus, David Nexon] HR 6252 - Medicare DMEPOS Competitive Acquisition Reform Act. A bill to amend part B of title XVIII of the Social Security Act to delay and reform the Medicare competitive acquisition program for purchase of durable medical equipment, prosthtics, orthotics, and supplies [Julie Cohen, David Nexon, Madeleine Smith]

Client expense: $924,074 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), White House Office

HR 1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631, Remote Monitoring Access Act of 2007 S. 2221, Transparency in Medical Device pricing Act of 2007 H.R. 6381, Medical Device Safety Act S. 2029 Gift Disclosure

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

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

HR 1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631, Remote Monitoring Access Act of 2007 S. 2221, Transparency in Medical Device pricing Act of 2007; price transparency H.R. 6381, Medical Device Safety Act, S. 3398 S. 2029 gift disclosure

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

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

HR 1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631, Remote Monitoring Access Act of 2007 S. 2221, Transparency in Medical Device pricing Act of 2007 H.R. 6381 Medical Device Safety Act, Preemption gift disclosure

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

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

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

Lilly Ledbetter Fair Pay Act (H.R. 2831; Medical Device Safety Act (H.R. 6381 and S. 3398) State Secrets Security Act (S. 2533)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lilly Ledbetter Fair Pay Act (H.R. 2831; Medical Device Safety Act (H.R. 6381 and S. 3398; State Secrets Security Act (S. 2533)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Import Safety - FDA Globalization Act (no bills introduced yet) FDA Preemption - H.R. 6381/S.3398 Medical Device Safety Act of 2008 Regulation of clinical diagnostic laboratory testing facilities (no bills introduced)

Client expense: $1,154,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Energy Regulatory Commission (FERC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 3014-Health Disparities, provisions relating to the treatment of heart disease patients in minority populations with a focus on SCA; S 1576-Health Disparities, provisions relating to the treatment of heart disease patients in minority populations with a focus on SCA; H.R. 2994-National Pain Care Policy Act of 2008, provisions related to pain care management and treatment;H.R. 6381- Medical Device Safety Act - provision related to preserving statutory federal preemption; S. 3398 - Medical Device Safety Act - provision related to preserving statutory federal preemption; S. 3387 - National Pain Care Policy Act of 2008 - provisions related to pain care management and treatment S. 3408 - Comparative Effectiveness Research Act of 2008 - provisions related to the establishment of a new entity to conduct comparative effectiveness research. S. 3409 - Drug and Device Accountability Act of 2008 - provisions related to device and drug import safety H.R. 4926 - Josh Miller Hearts Act - provisions related to establishing a grant program to ensure every elementary and secondary school in the country can obtain AEDs. H.R. 5839 - Safeguarding America's Pharmaceuticals Act of 2008 - provisions that might affect combination products H.R. 1028 - To create a Rural Policing Institute as part of the Federal Law Enforcement Training Center- provisions that might affect combination products H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 - provisions that might affect combination products S. 1695 - Follow-on Biologics - provisions that might affect combination products S. 1693 - Health Information Technology - provisions related to enhancing the adoption of nationwide interoperable health information technology system, improving health care quality and reducing health care costs in the United States. H.R. 3800 - Promoting Health Information Technology Act - provisions related to advancing the adoption of nationwide interoperable health information technology system, improving health care quality and reducing health care costs in the United States. H.R. 2184 - Enhanced Healthcare Value for All Act of 2007- provisions to expand comparative effectiveness research S.2221 - Transparency in Medical Device Pricing Act - provisions related to pricing for medical devices S.2029 - Physician Payments Sunshine Act of 2007- provisions related to providing transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies H.R. 3023 - Drug and Medical Device Company Gift Disclosure Act - provisions requiring manufacturers, packers and distributors of prescription drugs and medical devices to disclose certain gifts provided in connection with detailing, promotional, or other marketing activities, and for other purposes H.R. 5839 - Safeguarding America's Pharmaceuticals Act. Provisions that require tagging of pharmaceuticals with standardized numerical identifiers to track drug in all parts of supply chain. S. 3568 - To amend the Controlled Substances Act relative to the use of intrathecal pumps.

Client expense: $1,130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6381/S. 3398 - to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. [Julie Cohen, Brett Loper, Elizabeth Pika Sharp, Elizabeth Kegler] HR 1014/S. 573 - To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. [Brett Loper, Elizabeth Pika Sharp] * Direct to Consumer advertising of medical devices - No specific bill - [Julie Cohen, Leah Kegler, Brett Loper] * Import Safety - S. 3409/(No Specific House bill) - 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.[Brett Loper, Elizabeth Pika Sharp]

Client expense: $335,662 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE

H.R.6381/S.3398 - Medical Device Safety Act of 2008 H.R.5839 - Safeguarding America's Pharmaceuticals Act of 2008 S.3385 - FDA Food Safety Modernization Act Health Care Reform S.2221 Transparency in Medical Device Pricing Act of 2007 S. 1695 Biologics Price Competition and Innovation Act of 2007 S. 623/H.R. 1038 Access to Life-Saving Medicine Act H.R.5629 Pathway for Biosimlars Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007 S 2029 Physician Payments Sunshine Act of 2007 Topics relates to the safety of medical products H.R. 3610, the Food and Drug Import Safety Act S.2731/H.R. 5501 - Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reuthorization Act of 2008

Client expense: $940,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Potential impact of H.R. 3580 (P.L. 110-085), the drug labeling and preemption provisions of the Food and Drug Administration Amendments Act General background on drug labeling rules and preemption S. 3398/H.R. 6381, the Medical Device Safety Act of 2008

Client expense: $9,600,000 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

S. 2313, Strategies to Address Antimicrobial Resistance Act, Issues relating to HAI/MRSA surveillance and prevention H.R.3697, Strategies to Address Antimicrobial Resistance Act, Issues relating to HAI/MRSA surveillance and prevention S. 2278, Community and Healthcare-Associated Infections Reduction Act of 2007, Issues relating to HAI/MRSA surveillance and prevention H.R. 4214, Community and Healthcare-Associated Infections Reduction Act of 2007, Issues relating to HAI/MRSA surveillance and prevention S. 549, Preservation of Antibiotics for Medical Treatment Act of 2007, Issues relating to HAI/MRSA surveillance and prevention H.R. 962, Preservation of Antibiotics for Medical Treatment Act of 2007, Issues relating to HAI/MRSA surveillance and prevention S. 2525, MRSA Infection Prevention and Patient Protection Act, Issues relating to HAI/MRSA surveillance and prevention S. 2526, Worker Infection Protection Act, Issues relating to HAI/MRSA surveillance and prevention H.R. 4451, MRSA Research and Study Act of 2007, Issues relating to HAI/MRSA surveillance and prevention H.R. 1174, Healthy Hospitals Act of 2007, Issues relating to HAI/MRSA surveillance and prevention S. Res. 454, Designating the month of March 2008 as "MRSA Awareness Month", Issues relating to HAI/MRSA surveillance and prevention H. Res. 988, Designating the month of March 2008 as "MRSA Awareness Month", Issues relating to HAI/MRSA surveillance and prevention S. Res.454, A resolution designating the month of March 2008 as "MRSA Awareness Month" H.R. 6381, Medical Device Safety Act of 2008, Issues relating to pre-emption S. 3398, Medical Device Safety Act of 2008, Issues relating to pre-emption S.3409, Drug and Device Accountability Act of 2008, Issues relating to the FDA regulation of imported medical devices S.2221, Transparency in Medical Device Pricing Act of 2007, Issues relating to cost of care H.R.5839, Safeguarding America's Pharmaceuticals Act of 2008, Issues related to drug pedigree S.3408, A bill 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, Issues relating to comparative effectiveness

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

All asbestos related legislation, tort reform efforts, legislation aimed at limiting access to the courts, medical device safety, and arbitration related legislation. This includes H.R. 3010, S. 1782 (The Arbitration Fairness Act of 2008); HR 5312 (The Automobile Arbitration Fairness Act of 2008); HR 6126, S. 2838 (Fairness in Nursing Home Arbitration Act of 2008); and HR 6381, S. 3398 (Medical Device Safety Act of 2008).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Inpatient Prospective Payment System ruling for FY2009 - Provisions related to gainsharing/shared savings programs; S.2221 Transparency in Medical Device Pricing Act of 2007 - all provisions; S.2029 PhysicianPayments Sunshine Act of 2007 -all provisions; H.R. 5605 Physician Payments Sunshine Act of 2008-all provisions; H.R.6381 Medical Device Safety Act of 2008- all provisions related to federal premeptionof state laws with respect to Class III devices;

Client expense: $140,000 · Firm income: Not reported

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

H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: Direct-to-consumer drug advertising H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs

Client expense: $6,170,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 6381, Medical Device Safety Act H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008 H.R. 2193, Animal Protection Accountability Improvement Act Research on Bariatric Surgery

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, White House Office

S.1082/H.R. 2900 - Food and Drug Revitalization Act: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to include unique device identification systems for medical devices. H.R. 2900/S.1082 - Food and Drug Amendments Act of 2007: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to provide unique identification systems for medical devices. S.830/H.R. 1494 - Pediatric Medical Devices Safety and Improvement Act: to stimulate development of necessary medical devices for the pediatric population. H.R. 1956/H.R. 5629/H.R. 1038/S.623 - Regulation Devices Biologics and Combination Products by the FDA: to provide a pathway for follow-on biologics that would not allow for interchangeability without express physician approval. The Food and Drug Administration Globalization Act of 2008: to provide for the safety of medical devices manufactured in foreign countries. H.R. 6381 - Medical Device Safety Act of 2008: to amend the Food, Drug and Cosmetic Act with respect to liability under state and local requirements for medical devices.

Client expense: $365,000 · 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

-H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S.2274, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan", and for other purposes, regarding all provisions. -S.3409 "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.1378 "A bill 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. -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill 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. 1276, "Methamphetamine Production Prevention Act of 2008", 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. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; -S.2424, "A bill to ensure that all Americans have basic health literacy skills to function effectively as patients and health care consumers", regarding all provisions.

Client expense: $1,440,000 · Firm income: Not reported

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

HR 6381/S. 3398 - Medical Device Safety Amendments Act - oppose removal of federal preemption

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provide counsel on health care legislation/regulatory matters, including S. 2029 and H.R. 5605, Physician Payment Sunshine Act; H.R. 6381, S. 3398, Medical Device Safety Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6381 Medical Device Safety Act of 2008. To amend the Federal Food, Drug and Cosmetic Act with respect to liability under State and local requirements respecting devices; (Provisions relating to entire bill.)

Client expense: $1,970,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6381, Medical Device Safety Act of 2008. HR 4040, Consumer Product Safety Modernization Act. HR 6228, Ban Poisonous Additives Act of 2008, issues related to bisphenol A. S 3398, Medical Device Safety Act of 2008. S 3629, Consumer Credit Safety Commission Act of 2008. PL 110-314, Consumer Product Safety Modernization Act, issues related to the implementation. Issues related to auto safety. HR 1195, SAFETEA-LU Technical Corrections Act of 2008, issues related to auto safety. S 2567, Sales Tax Holiday Act of 2008. S 1782, Arbitration Fairness Act of 2007. HR 3010, Arbitration Fairness Act of 2007. S 2928, Ban Poisonous Additives Act of 2008, issues related to bisphenol A. Issues related to consumer agenda. Issues related to Internet, catalog, and advertising warning labels. Issues related to preemption of state consumer protection laws. Issues related to FTC priorities.

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

Government targets: Agriculture, Dept of (USDA), Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), SENATE, Transportation, Dept of (DOT), Treasury, Dept of

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

H.R. 6381, The Medical Device Safety Act of 2008 HCR-related legislation

Client expense: $75,000 · Firm income: Not reported

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

HR 1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631, Remote Monitoring Access Act of 2007 S. 2221, Transparency in Medical Device Pricing Act of 2007 H.R. 6381, Medical Device Safety Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6381, Medical Device Safety Act of 2008 HR 2994, National Pain Care Policy Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6381, Medical Device Safety Act of 2008 HR 2406, Healthcare Information Technology Enterprise Integration Act HR 3023, Drug and Medical Device Company Gift Disclosure Act HR 3610, Food and Drug Import Safety Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Arbitration legislation (H.R. 3010/S. 1782); Federal Preemption bill (H.R. 6381); Consumer Product Safety Commission Act (S. 2063/H.R. 4040); Coast Guard bill (S. 1892/H.R. 2830); asbestos bill (S. 742/H.R. 3339); cruise line bill (S. 3204/H.R. 6408); railroad safety bill (S. 1889); nursing home arbitration bill (S. 2838/H.R. 6126); financial reform bill (H.R. 1424); court secrecy (S. 2449)

Client expense: Not reported · Firm income: $260,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2994, National Pain Care Policy Act of 2008 & S. 3408, Comparative Effectiveness Research Act of 2008, issues pertaining to comparative effectiveness; H.R. 6381 / S. 3398, Medical Device Safety Act; S. 2029 Sunshine Act of 2007, all provisions pertaining to medical devices.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1323/ H.R. 2183, Commonsense Consumption act of 2007 (Entire bill) S. 1782/ H.R. 3010, Arbitration Fairness Act of 2007 (Entire bill) S. 1135, Fair Arbitration Act of 2007 (Entire bill) S. 221, Fair Contracts for Growers Act of 2007 (Entire bill) H.R. 1443, Consumer Fairness Act (Entire bill) H.R. 1519, American Homebuyers Protection act (Entire bill) S. 2041/ H.R. 4854, False Claims Act Corrections Act (Entire bill) S. 2449/ H.R. 5884, Sunshine in Litigation Act (Entire bill) S. 2450, To Amend the Federal Rules of Evidence to Address the Waiver of the Attorney-Client Privilege and the Work Product Doctrine (Entire bill) S. 2133, HOMES Act (Entire bill) S. 2136, Helping Families Save Their Homes in Bankruptcy Act (Entire bill) S. 2636, Foreclosure Prevention Act, Title IV (Bankruptcy) H.R. 3221, Dodd/ Shelby Amendment #4387, in Nature of a Substitute, Foreclosure Prevention Act, Durbin Amendment to the Substitute #4338 (Bankruptcy) S. 2838/ H.R. 6126, Fairness in Nursing Home Arbitration Act (Entire bill) H.R. 6381, Medical Device Pre-emption Act (Entire bill)

Client expense: $390,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

**see addendum page H.R. 5465 - the Military Pain Act of 2008, pain management H.R. 2994/S. 3387 - National Pain Care Policy Act, pain management H.R. 6381- Medical Safety Act of 2008, preemption S. 3398 - Medical Device Safety Act of 2008, preemption

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

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

**see addendum page S. 2029 - Physician Payments Sunshine Act of 2007, disclosure S. 2221 - Transparency in Medical Device Pricing Act of 2007, price transparency H.R. 5605 - Physician Payments Sunshine Act of 2008, disclosure S. 2449 - Sunshine in Litigation Act of 2007, settlement disclosure H.R. 6381/S. 3398 - Medical Device Safety Act of 2008, preemption H.R. 3610 - Food and Drug Import Safety Act of 2007, import safety S. 3409 - Drug and Device Accountability Act of 2008, import safety ***, no specific bill(s), trade with China, implementation of FDAAA, import safety

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

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

HR 2193 Animal Protection Accountability Improvement Act; HR 6381 Medical Device Safety Act; HR 6151 Responsibility in Drug and Device Advertising Act of 2008; General issues related to healthcare and healthcare reimbursement.

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

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

H.R. 6381, Medical Device Safety Act of 2008 (Pre-emption legislation to overturn Riegel v. Medtronic) S. 3408, Comparative Effectiveness Research Act of 2008 H.R. 3162, CHAMP Act (Comparative Effectiveness provisions) H.R. 2184, Enhanced Health Care Value for All Act of 2007 (Comparative Effectiveness provisions)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6381, Medical Device Safety Act of 2008 (Pre-emption legislation to overturn Riegel v. Medtronic)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6381/S. 3398 (Medical Device Safety Act); to amend the Food Drug and Cosmetic Act to clarify the scope of federal preemption of state law with regard to medical devices. Lobbying in response to Call to Action: Health Reform 2009 (a White Paper issued by Senator Baucus); specific interest in proposed health courts and other alternative malpractice compensation models; also lobbying regarding medical liability issues generally. General lobbying (not bill specific) regarding the issue of subrogation as it applies to ERISA-covered health plans.

Client expense: $1,190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6381, Medical Device Safety Act of 2008 (Pre-emption legislation to overturn Riegel v. Medtronic) S. 3408, Comparative Effectiveness Research Act of 2008 H.R. 3162, CHAMP Act (Comparative Effectiveness provisions) H.R. 2184, Enhanced Health Care Value for All Act of 2007 (Comparative Effectiveness provisions)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3408, Comparative Effectiveness Research Act of 2008 (Comparative Effectiveness provisions) H.R. 3162, CHAMP Act (Comparative Effectiveness provisions) H.R. 2184, Enhanced Health Care Value for All Act of 2007 (Comparative Effectiveness provisions) H.R. 6381, Medical Device Safety Act of 2008 (Pre-emption legislation to overturn Riegel v. Medtronic)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reversal of Supreme Court decision in Riegel v. Medtronic barring tort actions against medical device manufacturers whose products have received FDA approval; H.R. 6381- The Medical Device Safety Act of 2008, S-3398 - The Medical Device Safety Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6505, S. 2029 - The Physician Payments Sunshine Act H.R. 6381 - Medical Device Safety Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

House Discussion Draft of the Food and Drug Administration Globalization Act; Senate Draft Legislation regarding inspections of medical device manufacturing facilities; H.R. 6381& S. 3398, to Amend the Federal Food, Drug and Cosmetic Act with respect to liability under state and local requirements respecting devices and other related proposals; House and Senate proposals on comprehensive health care reform

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE