Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011

2012 · fourth_quarter · Health Issues

TIMOTHY MCBRIDE WHITNEY GARDINER mr JOHN KALAVRITINOS jr

Cited source text, amounts, lobbyists, and targets

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions).H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); S. 1995: A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes (All provisions related to the FDA and the regulation of medical devices generally); S.3187: Food and Drug Administration Safety and Innovation Act as well as Amendment 2151 on reclassification of hydrocodone sponsored by Senator Manchin; Coverage issues for Transcutaneous Electronic Stimulation for chronic lower back pain. Issue relating to MDUFA fees and sequestration.

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

H.R. 3206

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

2012 · first_quarter · Health Issues

Cited source text, amounts, lobbyists, and targets

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions).H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); S. 1995: A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes (All provisions related to the FDA and the regulation of medical devices generally)

COVIDIENclient→PODESTA GROUP, INC.

2012 · fourth_quarter · Health Issues

ANTHONY PODESTA STEPHEN NORTHRUP

Cited source text, amounts, lobbyists, and targets

Patient Protection and Affordable Care Act implementation. S. 99, American Medical Isotopes Production Act of 2011; issues related to nuclear medicine. FDA approval process/510(k). Medical device tax. H.R. 3209, Premarket Predictability Act. H.R. 3203 / S. 1943, Novel Device Regulatory Relief Act. H.R. 3230, Keeping America Competitive through Harmonization Act. H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act. H.R. 3211, Humanitarian Device Reform Act. H.R. 3208, Patients Come First Act. H.R. 3206, Cultivating Scientific Experts to Foster Innovation Act. H.R. 3214, Food and Drug Administration Mission Reform Act. H.R. 3207, Modernizing Laboratory Test Standards for Patients Act. H.R. 3204, Guidance Accountability and Transparency Act. S. 1700, The Medical Device Regulatory Improvement Act. S. 1865, The Patient Access to Medical Innovation Act. S. 1972, A bill to amend the Food and Drug Administrations mission. S. 1995, A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. CMS coverage for transcutaneous electrical nerve stimulation for lower back pain

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

H.R. 3206

2012 · fourth_quarter · Health Issues

Cited source text, amounts, lobbyists, and targets

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); S. 1995: A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes (All provisions related to the FDA and the regulation of medical devices generally); S.3187: Food and Drug Administration Safety and Innovation Act as well as Amendment 2151 on reclassification of hydrocodone sponsored by Senator Manchin; Coverage issues for Transcutaneous Electronic Stimulation for chronic lower back pain. Issue relating to MDUFA fees and sequestration.

Show 46 more cited filings

Cepheidclient→Cepheid

2012 · fourth_quarter · Health Issues

Cited source text, amounts, lobbyists, and targets

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

Cepheidclient→Cepheid

2012 · fourth_quarter · Medicare/Medicaid

Cited source text, amounts, lobbyists, and targets

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

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

H.R. 3206

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), 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), Natl Institutes of Health (NIH), SENATE

Cepheidclient→Cepheid

2012 · fourth_quarter · Medical/Disease Research/Clinical Labs

Cited source text, amounts, lobbyists, and targets

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S.1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

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

H.R. 3206

ADVANCED MEDICAL TECHNOLOGY ASSNclient→ADVANCED MEDICAL TECHNOLOGY ASSN

2012 · second_quarter · Health Issues

DUANE WRIGHT ELIZABETH SHARP JUAN SCOTT ms ELIZABETH KEGLER

Cited source text, amounts, lobbyists, and targets

Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics in the critical care setting. [Leah Kegler, Duane Wright] Issues related to the medical device user fee program [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 3187 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] S. 2516 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] H.R. 5651 Food and Drug Administration Reform Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics regulation [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the definition of durable for durable medical equipment [Duane Wright] HR 3209 Premarket Predictability Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3203 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3230 Keeping America Competitive Through Harmonization Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3205 FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3211 Humanitarian Device Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3208 Patients Come First Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3206 Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3214 Food and Drug Administration Mission Reform Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3207 Modernizing Laboratory Test Standards for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] HR 3204 Guidance Accountability and Transparency Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3847 Safety of Untested and New Devices Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3975 a bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 [Elizabeth Sharp, Elizabeth Kegler] HR 4056 Science and Technology Regulatory Relief Act [Elizabeth Sharp, Elizabeth Kegler] S 1700 Medical Device Regulatory Improvement Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1865 Patient Access to Medical Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1943 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1972 Food and Drug Administration Mission Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1995 Medical Device Patient Safety Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2067 Safe, Transparent, and Efficient Medical Device Act [Elizabeth Sharp, Elizabeth Kegler] S 2113 A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that encourage innovative products to benefit patients and improve public health [Elizabeth Sharp] S 2193 Ensuring Safe Medical Devices for Patients [Elizabeth Sharp, Elizabeth Kegler] S 2292 PATIENTS' FDA Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 2289 Better Pharmaceuticals and Devices for Children Act of 2012 [Elizabeth Sharp]

Client expense: $366,862 · Firm income: Not reported

HR 3206

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cepheidclient→Cepheid

2012 · third_quarter · Medical/Disease Research/Clinical Labs

Cited source text, amounts, lobbyists, and targets

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

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

H.R. 3206

Cepheidclient→Cepheid

2012 · third_quarter · Health Issues

Cited source text, amounts, lobbyists, and targets

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

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

H.R. 3206

Cepheidclient→Cepheid

2012 · third_quarter · Medicare/Medicaid

Cited source text, amounts, lobbyists, and targets

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

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

H.R. 3206

2012 · third_quarter · Health Issues

TIMOTHY MCBRIDE WHITNEY GARDINER mr JOHN KALAVRITINOS jr

Cited source text, amounts, lobbyists, and targets

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); S. 1995: A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes (All provisions related to the FDA and the regulation of medical devices generally); S.3187: Food and Drug Administration Safety and Innovation Act as well as Amendment 2151 on reclassification of hydrocodone sponsored by Senator Manchin; Coverage issues for Transcutaneous Electronic Stimulation for chronic lower back pain.

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

H.R. 3206

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

2012 · first_quarter · Health Issues

TIMOTHY MCBRIDE WHITNEY GARDINER mr JOHN KALAVRITINOS jr

Cited source text, amounts, lobbyists, and targets

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); S. 1995: A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes (All provisions related to the FDA and the regulation of medical devices generally)

Client expense: $700,000 · Firm income: Not reported

H.R. 3206

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

BOSTON SCIENTIFIC CORPORATIONclient→BOSTON SCIENTIFIC CORPORATION

2012 · third_quarter · Health Issues

BRENDA BECKER KRISTEN HEDSTROM MICHAEL MATTOON mr STEVEN LAPIERRE

Cited source text, amounts, lobbyists, and targets

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Client expense: $360,000 · Firm income: Not reported

H.R. 3206

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cepheidclient→Cepheid

2012 · second_quarter · Medicare/Medicaid

Cited source text, amounts, lobbyists, and targets

Please see next page Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

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

H.R. 3206

Cepheidclient→Cepheid

2012 · second_quarter · Health Issues

Cited source text, amounts, lobbyists, and targets

Please see attached page Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

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

H.R. 3206

Cepheidclient→Cepheid

2012 · second_quarter · Medical/Disease Research/Clinical Labs

Cited source text, amounts, lobbyists, and targets

Please see next page Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

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

H.R. 3206

ADVANCED MEDICAL TECHNOLOGY ASSNclient→ADVANCED MEDICAL TECHNOLOGY ASSN

2012 · second_quarter · Health Issues

DUANE WRIGHT ELIZABETH SHARP JUAN SCOTT ms ELIZABETH KEGLER

Cited source text, amounts, lobbyists, and targets

Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics in the critical care setting. [Leah Kegler, Duane Wright] Issues related to the medical device user fee program [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 3187 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] S. 2516 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] H.R. 5651 Food and Drug Administration Reform Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics regulation [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the definition of durable for durable medical equipment [Duane Wright] HR 3209 Premarket Predictability Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3203 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3230 Keeping America Competitive Through Harmonization Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3205 FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3211 Humanitarian Device Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3208 Patients Come First Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3206 Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3214 Food and Drug Administration Mission Reform Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3207 Modernizing Laboratory Test Standards for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] HR 3204 Guidance Accountability and Transparency Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3847 Safety of Untested and New Devices Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3975 a bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 [Elizabeth Sharp, Elizabeth Kegler] HR 4056 Science and Technology Regulatory Relief Act [Elizabeth Sharp, Elizabeth Kegler] S 1700 Medical Device Regulatory Improvement Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1865 Patient Access to Medical Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1943 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1972 Food and Drug Administration Mission Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1995 Medical Device Patient Safety Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2067 Safe, Transparent, and Efficient Medical Device Act [Elizabeth Sharp, Elizabeth Kegler] S 2113 A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that encourage innovative products to benefit patients and improve public health [Elizabeth Sharp] S 2193 Ensuring Safe Medical Devices for Patients [Elizabeth Sharp, Elizabeth Kegler] S 2292 PATIENTS' FDA Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 2289 Better Pharmaceuticals and Devices for Children Act of 2012 [Elizabeth Sharp]

Client expense: $559,267 · Firm income: Not reported

HR 3206

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medtronic, Inc.client→Medtronic, Inc.

2012 · second_quarter · Health Issues

JESSICA BATTAGLIA PETER SLONE ROSEMARY GARZA ms MELISSA SCHOOLEY

Cited source text, amounts, lobbyists, and targets

Patient Protection and Affordable Health Care Act (P.L. 111-148) - provisions relating to the implementation of this Act including Accountable Care Organizations, Physician Payment Disclosure, Patient Centered Outcomes Research Institute (PCORI), and other issues H.R. 3211 - Humanitarian Device Reform Act of 2011 - provisions relating to improving of humanitarian device regulation and foster device development for rare diseases S. 1865 - Patient Access to Medical Innovation Act - provisions relating to improving humanitarian device regulation and foster device development for rare diseases H.R. 3209 - Premarket Predictability Act of 2011 - provisions relating to a new streamlined review of new devices, require reviewers to provide scientific or regulatory rationale for major decisions and establish an expedited approval appellate process, and the establishment of the two Investigational Device Exemption pathways H.R. 3203 - Novel Device Regulatory Relief Act of 2011 - provisions relating to the streamlining the de novo classification process by striking the requirement that an applicant submit a 510(k) application before entering the de novo process H.R. 3206 - Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - provisions relating to the fixing of the FDA's conflict of interest policies to ensure the most knowledgeable experts are able to serve on FDA advisory committees H.R. 3847 - Safety of Untested and New Devices Act of 2012 - provisions relating to predicate nullification S. 2193 - Ensuring Safe Medical Devices for Patients - provisions relating to requiring the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices, and for other purposes S. 1995 - Medical Device Patient Safety Act - provisions relating to enhancing the Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes H.R. 3975 - Pediatric Medical Device Safety and Improvement Act - provisions relating to the continued availability of pediatric devices under the FDA humanitarian use device program. S. 2289 - The Better Pharmaceuticals and Devices Act for Children - provisions relating to the reauthorization of the Pediatric Device Consortia Initiative and to the continued availability of pediatric devices under the FDA humanitarian use device program. S. 3187 - Food and Drug Administration Reform Act of 2012, Public Law 112-144 - provisions relating to medical device user fees S. 2516 - Food and Drug Administration Safety and Innovation Act - provisions relating to medical device user fees H.R. 5651 - Food and Drug Administration Reform Act of 2012 - provisions relating to medical device user fees

Client expense: $1,450,000 · Firm income: Not reported

H.R. 3206

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

JOHNSON & JOHNSON SERVICES INCclient→JOHNSON & JOHNSON SERVICES, INC.

2012 · second_quarter · Health Issues

BRIAN BURNS CHARLES NAU DON BOHN GREGORY ARONIN KIMBERLY DAVIS MARK REESE mrs DARREL JODREY mrs JANE ADAMS ms JULIE COHEN ms LAURYL JACKSON

Cited source text, amounts, lobbyists, and targets

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3209, "Premarket Predictability Act of 2011", regarding all provisions. - HR 3203/ S 1943, "Novel Device Regulatory Relief Act of 2011", regarding all provisions. - HR 3230, "Keeping America Competitive Through Harmonization Act of 2011", regarding all provisions. - HR 3211, "Humanitarian Device Reform Act of 2011", regarding all provisions. - HR 3208, "Patients Come First Act of 2011", regarding all provisions. - HR 3206, "Cultivating Scientific Expertise to Foster Inovation for Patients Act of 2011", regarding all provisions. - HR 3214/ S 1972, "Food and Drug Administration Mission Reform Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - HR 3204, "Guidance Accountability and Transparency Act of 2011", regarding all provisions. - HR 3205, "FDA Renewing Efficiency From Outside Reviewer Management Act of 2011", regarding all provisons. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Acess to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards.

Client expense: $1,200,000 · Firm income: Not reported

HR 3206

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

2012 · second_quarter · Health Issues

TIMOTHY MCBRIDE WHITNEY GARDINER mr JOHN KALAVRITINOS jr

Cited source text, amounts, lobbyists, and targets

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); S. 1995: A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes (All provisions related to the FDA and the regulation of medical devices generally); S.3187: Food and Drug Administration Safety and Innovation Act as well as Amendment 2151 on reclassification of hydrocodone sponsored by Senator Manchin; Coverage issues for Transcutaneous Electronic Stimulation for chronic lower back pain.

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

H.R. 3206

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

BOSTON SCIENTIFIC CORPORATIONclient→BOSTON SCIENTIFIC CORPORATION

2012 · second_quarter · Health Issues

BRENDA BECKER JEAN FRICK KRISTEN HEDSTROM MICHAEL MATTOON mr STEVEN LAPIERRE

Cited source text, amounts, lobbyists, and targets

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Client expense: $360,000 · Firm income: Not reported

H.R. 3206

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

CHAMBER OF COMMERCE OF THE U.S.A.client→CHAMBER OF COMMERCE OF THE U.S.A.

2012 · first_quarter · Pharmacy

R JOSTEN REED RUBINSTEIN ROLF LUNDBERG THOMAS DONOHUE WILLIAM KOVACS

Cited source text, amounts, lobbyists, and targets

H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act Potential FDA reform legislation (specific legislation not yet introduced)

Client expense: $20,200,000 · Firm income: Not reported

H.R. 3206

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

CHAMBER OF COMMERCE OF THE U.S.A.client→CHAMBER OF COMMERCE OF THE U.S.A.

2012 · first_quarter · Government Issues

CHRISTIAN ZUR DANIEL HILLENBRAND GIOVANNI CORATOLO GLENN SPENCER KEITH HOLMAN R JOSTEN REED RUBINSTEIN ROLF LUNDBERG RONALD BIRD RONALD EIDSHAUG ROSS EISENBERG SARAH SUCKOW THOMAS DONOHUE WILLIAM KOVACS mr MARTIN REGALIA mr PAUL CASASCO mr TIMOTHY MANEY

Cited source text, amounts, lobbyists, and targets

H.R. 10 / S. 299, Regulations From the Executive in Need of Scrutiny Act of 2011 H.R. 373, Unfunded Mandates Information and Transparency Act of 2011 H.R.735 / S. 119, Government Neutrality in Contracting Act H.R. 931, To make participation in the American Community Survey voluntary, except with respect to certain basic questions H.R. 2250 / S. 1392, EPA Regulatory Relief Act of 2011 H.R. 2309 / S. 1625, Postal Reform Act of 2011 H.R. 2401, Transparency in Regulatory Analysis of Impacts on the Nation (TRAIN) Act of 2011 H.R. 2483, Whistleblower Improvement Act of 2011 H.R. 2898 / S.1438, Regulation Moratorium and Jobs Preservation Act of 2011 H.R. 3010 / S. 1606, Regulatory Accountability Act of 2011 H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act H.R. 3416 / S. 1483, Incorporation Transparency and Law Enforcement Act H.R. 3596, United States Call Center Worker and Consumer Protection Act H.R. 3634, Federal Prison Industries Competition in Contracting Act of 2011 H.R. 3813, Securing Annuities for Federal Employees Act of 2012 H.R. 3850, Government Efficiency through Small Business Contracting Act of 2012 H.R. 3851, Small Business Advocate Act of 2012 H.R. 3862, Sunshine for Regulatory Decrees and Settlements Act of 2012 H.R. 3893, Subcontracting Transparency and Reliability Act of 2012 H.R. 3980, Small Business Opportunity Act of 2012 H.R. 3985, Building Better Business Partnerships Act of 2012 H.R. 3987, Small Business Protection Act of 2012 H.R. 4078, Regulatory Freeze for Jobs Act of 2012 H.R. 4081, Contractor Opportunity Protection Act of 2012 S. 370, A bill to require contractors to notify small business concerns that have been included in offers relating to contracts let by Federal agencies, and for other purposes S. 1536, NOTICE Act of 2011 S. 1736, Acquisition Savings Reform Act of 2011 S. 1720, Jobs Through Growth Act S. 1789, 21st Century Postal Service Act of 2011 S. 2169, Federal Prisons Accountability Act of 2012 S. 3862, Sunshine for Regulatory Decrees and Settlements Act FY 2013 Appropriations Legislation Farm and agricultural legislation (specific legislation not yet introduced) Department of Agriculture Animal and Plant Health Inspection Service Proposed Rule: Importation of Wood Packaging Material From Canada, Docket No. APHIS-2010-0019 Executive Order 12688, Estimating direct and indirect employment impacts of regulations - need for surveys and experiments to establish compliance costs Executive Order 13563, Improving Regulation and Regulatory Review Various issues relating to Congressional oversight of the NLRB and DOL (no specific legislation); statistical programs (need for consistent and timely data to support economic impact analysis of regulation impacts); NIOSH Diesel Emissions study data quality; regulatory implementation of the Food Safety Modernization Act, PL 111-353

Client expense: $20,200,000 · Firm income: Not reported

H.R. 3206

Cepheidclient→Cepheid

2012 · first_quarter · Medicare/Medicaid

Cited source text, amounts, lobbyists, and targets

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

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

H.R. 3206

Cepheidclient→Cepheid

2012 · first_quarter · Health Issues

Cited source text, amounts, lobbyists, and targets

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

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

H.R. 3206

Cepheidclient→Cepheid

2012 · first_quarter · Medical/Disease Research/Clinical Labs

Cited source text, amounts, lobbyists, and targets

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S.1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

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

H.R. 3206

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2012 · first_quarter · Consumer Issues/Safety/Products

ALYSON PUSEY ANDREW EMMETT CATHLEEN ENRIGHT DAVID EDWARDS JEANNE HAGGERTY MATTHEW SCHUMAKER MELISSA BOWIE SANDRA DENNIS SARA RADCLIFFE TOM DILENGE TRACEY LATURNER mr BRENT DELMONTE mr DANA O'BRIEN jr mr MATTHEW O'MARA ms ANNA WEINSTEIN ms ELIZABETH ESHAM

Cited source text, amounts, lobbyists, and targets

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Client expense: $1,820,000 · Firm income: Not reported

H.R.3206

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2012 · first_quarter · Health Issues

ALAN EISENBERG ALYSON PUSEY ANDREW EMMETT JEANNE HAGGERTY JOSEPH DAMOND KELLY CAPPIO LAUREL TODD LILA FEISEE MATTHEW SCHUMAKER MELISSA BOWIE PHYLLIS ARTHUR SANDRA DENNIS SARA RADCLIFFE SHELLY MUI-LIPNIK TOM DILENGE TRACEY LATURNER mr BRENT DELMONTE mr CHARLES FRITTS mr ROY ZWAHLEN ms ANNA WEINSTEIN

Cited source text, amounts, lobbyists, and targets

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Client expense: $1,820,000 · Firm income: Not reported

H.R.3206

ADVANCED MEDICAL TECHNOLOGY ASSNclient→ADVANCED MEDICAL TECHNOLOGY ASSN

2012 · first_quarter · Health Issues

DUANE WRIGHT ELIZABETH SHARP JUAN SCOTT ms ELIZABETH KEGLER

Cited source text, amounts, lobbyists, and targets

Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to the medical device user fee program [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Sen. Orrin Hatch draft BETTER Patient Care Act. To restructure how the FDA regulates certain advanced diagnostics [JC Scott, Duane Wright] H.R 2182/S. 1734 Generating Antibiotic Incentives Now [Duane Wright, Leah Kegler, Elizabeth Sharp, JC Scott] Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics regulation [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the definition of durable for durable medical equipment [Duane Wright] HR 3209 Premarket Predictability Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3203 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3230 Keeping America Competitive Through Harmonization Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3205 FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3211 Humanitarian Device Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3208 Patients Come First Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3206 Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3214 Food and Drug Administration Mission Reform Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3207 Modernizing Laboratory Test Standards for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] HR 3204 Guidance Accountability and Transparency Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3847 Safety of Untested and New Devices Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3975 a bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 [Elizabeth Sharp, Elizabeth Kegler] HR 4056 Science and Technology Regulatory Relief Act [Elizabeth Sharp, Elizabeth Kegler] S 1700 Medical Device Regulatory Improvement Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1865 Patient Access to Medical Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1943 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1972 Food and Drug Administration Mission Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1995 Medical Device Patient Safety Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2067 Safe, Transparent, and Efficient Medical Device Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2113 A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that encourage innovative products to benefit patients and improve public health [Elizabeth Sharp] S 2193 Ensuring Safe Medical Devices for Patients [Elizabeth Sharp, Elizabeth Kegler]

Client expense: $378,488 · Firm income: Not reported

HR 3206

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CHAMBER OF COMMERCE OF THE U.S.A.client→CHAMBER OF COMMERCE OF THE U.S.A.

2012 · first_quarter · Government Issues

Cited source text, amounts, lobbyists, and targets

H.R. 10 / S. 299, Regulations From the Executive in Need of Scrutiny Act of 2011 H.R. 373, Unfunded Mandates Information and Transparency Act of 2011 H.R.735 / S. 119, Government Neutrality in Contracting Act H.R. 931, To make participation in the American Community Survey voluntary, except with respect to certain basic questions H.R. 2250 / S. 1392, EPA Regulatory Relief Act of 2011 H.R. 2309 / S. 1625, Postal Reform Act of 2011 H.R. 2401, Transparency in Regulatory Analysis of Impacts on the Nation (TRAIN) Act of 2011 H.R. 2483, Whistleblower Improvement Act of 2011 H.R. 2898 / S.1438, Regulation Moratorium and Jobs Preservation Act of 2011 H.R. 3010 / S. 1606, Regulatory Accountability Act of 2011 H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act H.R. 3416 / S. 1483, Incorporation Transparency and Law Enforcement Act H.R. 3596, United States Call Center Worker and Consumer Protection Act H.R. 3634, Federal Prison Industries Competition in Contracting Act of 2011 H.R. 3813, Securing Annuities for Federal Employees Act of 2012 H.R. 3850, Government Efficiency through Small Business Contracting Act of 2012 H.R. 3851, Small Business Advocate Act of 2012 H.R. 3862, Sunshine for Regulatory Decrees and Settlements Act of 2012 H.R. 3893, Subcontracting Transparency and Reliability Act of 2012 H.R. 3980, Small Business Opportunity Act of 2012 H.R. 3985, Building Better Business Partnerships Act of 2012 H.R. 3987, Small Business Protection Act of 2012 H.R. 4078, Regulatory Freeze for Jobs Act of 2012 H.R. 4081, Contractor Opportunity Protection Act of 2012 S. 370, A bill to require contractors to notify small business concerns that have been included in offers relating to contracts let by Federal agencies, and for other purposes S. 1536, NOTICE Act of 2011 S. 1736, Acquisition Savings Reform Act of 2011 S. 1720, Jobs Through Growth Act S. 1789, 21st Century Postal Service Act of 2011 S. 2169, Federal Prisons Accountability Act of 2012 S. 3862, Sunshine for Regulatory Decrees and Settlements Act FY 2013 Appropriations Legislation Farm and agricultural legislation (specific legislation not yet introduced) Department of Agriculture Animal and Plant Health Inspection Service Proposed Rule: Importation of Wood Packaging Material From Canada, Docket No. APHIS-2010-0019 Executive Order 12688, Estimating direct and indirect employment impacts of regulations - need for surveys and experiments to establish compliance costs Executive Order 13563, Improving Regulation and Regulatory Review Various issues relating to Congressional oversight of the NLRB and DOL (no specific legislation); statistical programs (need for consistent and timely data to support economic impact analysis of regulation impacts); NIOSH Diesel Emissions study data quality; regulatory implementation of the Food Safety Modernization Act, PL 111-353

Client expense: $20,200,000 · Firm income: Not reported

H.R. 3206

CHAMBER OF COMMERCE OF THE U.S.A.client→CHAMBER OF COMMERCE OF THE U.S.A.

2012 · first_quarter · Pharmacy

R JOSTEN REED RUBINSTEIN ROLF LUNDBERG THOMAS DONOHUE WILLIAM KOVACS

Cited source text, amounts, lobbyists, and targets

H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act Potential FDA reform legislation (specific legislation not yet introduced)

Client expense: $20,200,000 · Firm income: Not reported

H.R. 3206

JOHNSON & JOHNSON SERVICES INCclient→JOHNSON & JOHNSON SERVICES, INC.

2012 · first_quarter · Health Issues

BRIAN BURNS CHARLES NAU DON BOHN GREGORY ARONIN MARK REESE mrs DARREL JODREY mrs JANE ADAMS ms JULIE COHEN ms LAURYL JACKSON

Cited source text, amounts, lobbyists, and targets

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3209, "Premarket Predictability Act of 2011", regarding all provisions. - HR 3203/ S 1943, "Novel Device Regulatory Relief Act of 2011", regarding all provisions. - HR 3230, "Keeping America Competitive Through Harmonization Act of 2011", regarding all provisions. - HR 3211, "Humanitarian Device Reform Act of 2011", regarding all provisions. - HR 3208, "Patients Come First Act of 2011", regarding all provisions. - HR 3206, "Cultivating Scientific Expertise to Foster Inovation for Patients Act of 2011", regarding all provisions. - HR 3214/ S 1972, "Food and Drug Administration Mission Reform Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - HR 3204, "Guidance Accountability and Transparency Act of 2011", regarding all provisions. - HR 3205, "FDA Renewing Efficiency From Outside Reviewer Management Act of 2011", regarding all provisons. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Acess to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards.

Client expense: $2,260,000 · Firm income: Not reported

HR 3206

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

2012 · first_quarter · Health Issues