Medical Device Safety Act of 2008

Health Care Reform - including increased access and coverage, physician payment reform, improved quality, reducing disparities, increased support for prevention and wellness, medical homes, Affordable Health Choices Act, US House Tricomm Health Reform Proposal, Senate Finance Policy Options Papers, Senate HELP Committee Proposals, Proposals to eliminate tax deductibility for direct to consumer advertising Medicare and Medicaid - payment and delivery system reform, SGR, comparative effectiveness research, increased transparency, quality reporting, tiering and measurement tools (no legislation) Medical Liability reform efforts to reduce defensive medicine (no legislation) Antitrust reform to allow physicians to organize new organizations for the delivery of care and to discuss payment methodologies openly (no legislation) Health Information Technology - funding and implementation of Electronic Medical Records - development of interoperable standards, privacy and confidentiality provisions (no legislation) Physician workforce - shortages in physicians including primary care, decreasing medical student debt HR 7114, S 3614, Independence at Home Act - legislation to allow persons with chronic illness to stay at home with improved care coordination S. 3398, Medical Device Safety Act legislation which would overturn Supreme Court Decision exempting medical device manufacturers from liability if the device was FDA approved S. 301, Physician Payment Sunshine Act legislation which would require pharmaceutical companies and device manufactures to disclose gifts and other contributions to physicians HR 1427/S 726 Providing Innovative Access to Life Saving Medicines Act Rescission of the Regulation Entitled Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law; Proposal (RIN 0991-AB49), 74 Fed. Reg. 10207 (March 10, 2009) Comments to Department of Health and Human Services on Meaningful use of Electronic Health Records

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

Government targets: Executive Office of the President (EOP), 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), Pay Check Fairness Act, Judicial Nominations

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

HR 2 Children's Health Insurance Program Reauthorization Act 2009. S301 Physician Payments Sunshine Act 2009. HR380, S623, Access to Life-Saving Medicine Act; Follow-on biologics, importation, HR3610 Food and Drug Safety Act of 2007: Import safety; HR5839, Safeguard Americans Pharmaceuticals Act; S2029, Physician's Payment Sunshine Act; Reporting periodicity, pre-emption. HR1427 and HR1038, Access to Life-Saving Medicine Act; follow-on biologics; HR1956, Patient Protection and Innovative Biologic Medicines Act of 2007; follow-on biologics; HR3610, Food and Drug Import Safety Act of 2007; Import safety HR 6151, Responsibilty in Drug and Device Advertising Act of 2008: Direct-to-consumer advertising; S 242, Pharmaceutical Market Acess and Drug Safety Act of 2007: importation; S 334, Healthy Americans Act: non-interference; 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 3398, Medical Device Safety Act of 2008: preemption issues; S 3409, Drug and Device Accountability Act of 2008: import safety

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

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: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support proposals to decrease defensive medicine (no legislation) S. 3398 Medical Device Safety Act legislation which would overturn Supreme Court Decision exempting medical device manufacturers from liability if the device was FDA approved

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

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

Health Care Reform - including increased access and coverage, improved quality, reducing disparities, increased support for prevention and wellness, medical homes (no legislation) Medicare and Medicaid - payment and delivery system reform, SGR, comparative effectiveness research, increased transparency, quality reporting, tiering and measurement tools (no legislation) House and Senate Budget Resolution supporting rebasing of Medicare physician payments Medical Liability reform efforts to reduce defensive medicine Antitrust reform to allow physicians to organize new organizations for the delivery of care and to discuss payment methodologies openly (no legislation) PL 111-3 Childrens Health Insurance Program Reauthorization Act of 2009 - law reauthorizing the SCHIP program for children Health Information Technology - funding and implementation of Electronic Medical Records - development of interoperable standards, Privacy and confidentiality provisions (no legislation) Physician workforce: shortages in physicians including primary care, decreasing medical student debt (no legislation) HR 7114, S 3614, Independence at Home Act - legislation to allow persons with chronic illness to stay at home with improved care coordination S. 3398, Medical Device Safety Act legislation which would overturn Supreme Court Decision exempting medical device manufacturers from liability if the device was FDA approved S. 301, Physician Payment Sunshine Act legislation which require pharmaceutical companies and device manufactures to disclosure gifts and other contributions to physicians Federal Trade Commission Final Rule on Identity Theft Red Flags; 16 CFR Part 681; Application of the Red Flags Rule to Physicians - oppose Red Flag Rule requiring physicians to implement identity theft programs in their offices Recovery Audit Contractor (RAC) program - oppose provisions of the new Recovery Audit Program Letter to CMS requesting opportunity to comment on changes to Medicare Quality Improvement Organizations

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

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

Health Care Reform - including increased access and coverage, improved quality, reducing disparities, increased support for prevention and wellness, medical homes (no legislation) Medicare and Medicaid - payment and delivery system reform, SGR, comparative effectiveness research, increased transparency, quality reporting, tiering and measurement tools (no legislation) House and Senate Budget Resolution supporting rebasing of Medicare physician payments Medical Liability reform efforts to reduce defensive medicine (no legislation) Antitrust reform to allow physicians to organize new organizations for the delivery of care and to discuss payment methodologies openly (no legislation) PL 111-3 Childrens Health Insurance Program Reauthorization Act of 2009 - law reauthorizing the SCHIP program for children Health Information Technology - funding and implementation of Electronic Medical Records - development of interoperable standards, privacy and confidentiality provisions (no legislation) Physician workforce - shortages in physicians including primary care, decreasing medical student debt (no legislation) HR 7114, S 3614, Independence at Home Act - legislation to allow persons with chronic illness to stay at home with improved care coordination S. 3398, Medical Device Safety Act legislation which would overturn Supreme Court Decision exempting medical device manufacturers from liability if the device was FDA approved S. 301, Physician Payment Sunshine Act legislation which would require pharmaceutical companies and device manufactures to disclose gifts and other contributions to physicians

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

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

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

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

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

Health care reform: proposals for major health care reform, including Senator Baucus' white paper Call to Action Health Care Reform 2009 and anticipated legislation for 111th Congress. No bill #'s yet. HR 1424 - Emergency Economic Stabilization Act of 2008 - Title V, Subtitle B - Paul Wellstone and Pete Domenicia Health Parity and Addiction Equity Act of 2008, Section 511 requiring group health plans that provide both (i) medical and surgical benefits and cont (ii) mental health or substance use disorder benefits to meet certain requirements to provide parity between (i) and (ii). Medical Device Safety Act of 2008 S 3398 Comparative Effectiveness Research Act of 2008 S 3408 Possible future legislation - health care reform to include long term services and supports for people with disabilities and chronic conditions.

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

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

HR 380, S 623, Access to Life-Saving Medicine Act; Follow-on biologics, importation; HR 3610 Food and Drug Import Safety Act of 2007; Import safety; HR 5839, Safeguard Americans Pharmaceuticals Act; S 2029, Physician's Payment Sunshine Act; Reporting periodicity, pre-emption. HR 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; HR 3610, Food and Drug Import Safety Act of 2007: import safety HR 6151, Responsibilty in Drug and Device Advertising Act of 2008: Direct-to-consumer advertising; S 242, Pharmaceutical Market Acess and Drug Safety Act of 2007: importation; S 334, Healthy Americans Act: non-interference; 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 3398, Medical Device Safety Act of 2008: preemption issues; S 3409, Drug and Device Accountability Act of 2008: import safety

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

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

S.3398 Medical Device Safety Act of 2008- all provisions related to federal pre-emption of state laws with respect to Call III devices; S.3408 Comparative Effectiveness Research Act of 2008- all provisions related to establishment of a Health care Comparative Research Institute; and FDA Globalization Act - provisions related to inspection fees and schedules. S. 3408: Comparative Effectiveness Research Act of 2008 - All provisions related to establishment of a Health Care Comparative Research Institute; FDA Globalization Act (draft legislation in House and Senateno bill number yet) - Provisions related to inspection fees and schedules

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)

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

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

- Food and Drug Administration Globalization Act of 2008, a bill to increase FDA inspection of manufacturers in the US and abroad. - HR 6381Medical Device Safety Act of 2008, a bill that would remove federal preemption protection for certain medical devices. - HR 2900 Implementation of Food and Drug Administration Amendments Act of 2007, a bill to revise and extend the user-fee programs for prescription drugs and for medical devices. - HR 3014 Health Disparities, a bill to address disparities in the delivery of health care, specifically as it relates to cardiovascular care. - S. 3398 Medical Device Safety Act of 2008, a bill that would remove federal preemption protection for certain medical devices. - HR 6432 Animal Drug User Fee Act, a provision to make technical corrections to device user fee program.

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

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

Preemption HR. 6831, S. 3398

Client expense: $118,254 · Firm income: Not reported

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

**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

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

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

FDA Sentinel Initiative (post market surveillance); H.R. 3580; FDA Guidance Documents; H.R. 3160 - Import Safety; Federal Preemption (S.3398 and H.R. 6381); Direct to Consumer Ads (H.R. 6151)

Client expense: $16,115 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

HR 4040, Consumer Product Safety Modernization Act. Issues related to direct consumer advertising of medical devices. HR 6381, Medical Device Safety Act of 2008. S 3398, Medical Device Safety Act of 2008.

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

Government targets: Agriculture, Dept of (USDA), Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 6331/S.3101 - Medicare Improvements for Patients and Providers Act of 2008, Section 153, 154 S.3118 - Preserving Access to Medicare Act of 2008, Section 152 H.R. 6252/S. 3144 Medicare DMEPOS Competitive Acquisition Reform Act of 2008 Protection of private sector delivery H.R. 1321 - Medicare Advanced Laboratory Diagnostics Act of 2007 Proposal to repeal CMS's Least Costly Alternative reimbursement policy for selected medicines H.R. 638/S. 3398 - Medicaid Device Safety Act of 2008 H.R.3162 - Children's Health and Medicare Protection Act of 2007 H.R.4854 - False Claims Act Correction Act of 2007 HR 3326 - Early Treatment for HIV Act of 2007

Client expense: $1,780,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

**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

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 migt 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

Client expense: $1,270,000 · 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

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] HR 2994 - To amend the Public Health Service Act with respect to pain care. [Brett Loper] * Direct to Consumer advertising of medical devices - No specific bill - [Julie Cohen, Leah Kegler] * 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: $484,537 · 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), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA)

Preemption HR. 6381; S. 3398

Client expense: $115,817 · Firm income: Not reported

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

H.R.3251, Medicare Safe Needle Disposal Coverage Act of 2007, Issues related to sharps disposal S.1909, Medicare Safe Needle Disposal Coverage Act of 2007, Issues related to sharps disposal H.R. 5501, To authorize appropriations for fiscal years 2009 through 2013 to provide assistance to foreign countries to combat HIV/AIDS, tuberculosis, and malaria, and for other purposes, Issues related to HIV/AIDS and Tuberculosis S. 2731, A bill to authorize appropriations for fiscal years 2009 through 2013 to provide assistance to foreign countries to combat HIV/AIDS, tuberculosis, and malaria, and for other purposes, Issues related to funding for global assistance for HIV/AIDS, tuberculosis, malaria, and other diseases H.R.5839, Safeguarding America's Pharmaceuticals Act of 2008, Issues related to pedigree H.R.3697, Strategies to Address Antimicrobial Resistance Act, Issues relating to HAI/MRSA surveillance and prevention S. 2313, 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 H.R.5839, Safeguarding America's Pharmaceuticals Act of 2008, Issues relating to drug pedigree

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

Government targets: HOUSE OF REPRESENTATIVES, 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: $1,950,000 · Firm income: Not reported

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