To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - Issues related to blood glucose meters. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - Issues related to over the counter medicine regulatory reform - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines

Client expense: $3,650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 1736, aims to improve FDA's process for inspecting medical device manufacturing facilities and granting export certificates. H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents. H.R. 1652, would require FDA to issue regulations for over-the-counter hearing aids H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710). S. 1070, which reflects the accessories language that's included in the manager's amendment (Section 709) ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment

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

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 1736, aims to improve FDA's process for inspecting medical device manufacturing facilities and granting export certificates. H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents. H.R. 1652, would require FDA to issue regulations for over-the-counter hearing aids H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710). S. 1070, which reflects the accessories language that's included in the manager's amendment (Section 709) ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment

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

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to implementation of the 21st Century Cures Act Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies H.R. 2430 and S. "934" The FDA Reauthorization Act H.R. 2474 Medical Product Review Harmonization Act H.R. 2144 and SS. 1070 related to the classification of medical device accessories H.R. 2483 and S. 1183 related to modifications to medical devices S. 1069 related to postmarket regulation of medical devices H.RR. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications S.404 and H.R. 1736 bills to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications Issues related to diagnostics regulation Issues related to diagnostics payment reform Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of, reimbursement for, and access to cancer diagnostics, imaging, and radiation therapies Issues related to federal regulation of the distribution and supply chain for medical devices

S. 934/ H.R. 2430, The FDA Reauthorization Act (FDARA)- Issues related to the re-authorization of the Medical Device User Fees, facility inspections and risked based classifications of accessories. S. 404/ H.R. 1736- A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications- All provisions H.R. 2144 Risk-Based Classification of Accessories Act of 2017 Issues related to value based healthcare and modernization of fraud and abuse laws. H.R. 1628 American Health Care Act, provisions that would permanently repeal the medical device excise tax Senate Better Care Reconciliation Act 2017, provisions that would permanently repeal the medical device excise tax; Senators Cassidy and Graham proposal. Issues related to opioids/chronic pain

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

MDUFA Reauthorization (HR 2430 S934), FDA Inspections (HR1736 S404), MDET repeal

Client expense: $135,000 · Firm income: Not reported

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

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - Issues related to blood glucose meters. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - Issues related to over the counter medicine regulatory reform - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B

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

Issues related to post-market surveillance of medical devices and unique device identifiers. Reauthorization of the medical device user fee agreement (H.R. 2430/S. 934, FDA Reauthorization Act of 2017), including policy issues related to FDA inspections reform (S. 404, H.R. 1736), 510(k) process (H.R. 2474, Medical Product Review Harmonization Act of 2017), and accessories (H.R. 2144, Risk-Based Classification of Accessories Act of 2017; S. 1070, Realizing Intended Safety for Certain Accessories Act of 2017.

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE

Issues related to post-market surveillance of medical devices and unique device identifiers. Reauthorization of the medical device user fee agreement (H.R. 2430/S. 934, FDA Reauthorization Act of 2017), including policy issues related to FDA inspections reform (S. 404, H.R. 1736), 510(k) process (H.R. 2474, Medical Product Review Harmonization Act of 2017), and accessories (H.R. 2144, Risk-Based Classification of Accessories Act of 2017; S. 1070, Realizing Intended Safety for Certain Accessories Act of 2017.

Client expense: $560,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)

MDUFA Reauthorization (HR 2430 S934), FDA Inspections (HR1736 S404), MDET repeal

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

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

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to implementation of the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies H.R. 2430 and S. 934 The FDA Reauthorization Act H.R. 2474 Medical Product Review Harmonization Act H.R. 2144 and SS. 1070 related to the classification of medical device accessories H.R. 2483 and S. 1183 related to modifications to medical devices S. 1069 related to postmarket regulation of medical devices H.RR. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications S.404 and H.R. 1736 bills to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications Issues related to diagnostics regulation Issues related to diagnostics payment reform Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues related to AHCA/BCRA

Client expense: $760,000 · Firm income: Not reported

Implementation of PL 114-255: 21st Century Cures Act Implementation of PL-111-148: PPACA S. 149, Medical Device Access & Innovation Protection Act Policies promoting medical innovation Heart Valve Disease Awareness H.R. 2430: FDA Reauthorization Act of 2017 S. 934: FDA Reauthorization of 2017 H.R. 184, Protect Medical Innovation Act of 2017 Post-market Surveillance H.R. 2430: FDA Reauthorization Act of 2017 H.R. 2144: Risk-Based Classification of Accessories Act of 2017 H.R.1736: To amend the Federal Food, Drug, and Cosmetic Act S. 404: A bill to amend the Federal Food, Drug, and Cosmetic Act

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

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

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - Issues related to blood glucose meters. - Issues related to 21st Century Cures Act. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2430, FDA Reauthorization Act - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects

Client expense: $1,290,000 · Firm income: Not reported

S. 934/ H.R. 2430, The FDA Reauthorization Act (FDARA)- Issues related to the re-authorization of the Medical Device User Fees, facility inspections and risked based classifications of accessories. S. 404/ H.R. 1736- A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications- All provisions H.R. 2144 Risk-Based Classification of Accessories Act of 2017 Issues related to value based healthcare H.R. 1628 American Health Care Act, provisions that would permanently repeal the medical device excise tax Senate Better Care Reconciliation Act 2017, provisions that would permanently repeal the medical device excise tax Issues related to opioids/chronic pain

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 1736, aims to improve FDA's process for inspecting medical device manufacturing facilities and granting export certificates. H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents. H.R. 1652, would require FDA to issue regulations for over-the-counter hearing aids H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710). S. 1070, which reflects the accessories language that's included in the manager's amendment (Section 709) ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment

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

Issues related to post-market surveillance of medical devices and unique device identifiers. Reauthorization of the medical device user fee agreement, including policy issues related to FDA inspections reform (S. 404, H.R. 1736), 510(k) process, and accessories.

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

Government targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues related to user fees. - Issues regarding drug pricing. - Issues related to diagnostic reform. - Issues related to blood glucose meters. - Issues related to 21st Century Cures Act. - Issues related to CDC guidelines related to surgical site infections. - Issues related to FDA inspections legislation (not yet introduced)

Client expense: $1,060,000 · Firm income: Not reported

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries Issues related to the regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to implementation of the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies Issues related to the regulation of combination products S404 and HR 1736 bills to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications Issues related to diagnostics regulation Issues related to diagnostics payment reform Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies

Client expense: $1,070,000 · Firm income: Not reported

Issues related to the re-authorization of the Medical Device User Fees S. 404/ H.R. 1736- A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications- All provisions Issues related to value based healthcare Education about FDA regulation of hysteroscopic morcellators H.R. 1628 American Health Care Act, provisions that would permanently repeal the medical device excise tax

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Support for repeal of the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Advancing Breakthrough Devices for Patients Act to promote innovation and regulatory efficiency. (Legislation not yet introduced). H.R. 1736, Legislation to improve processes for inspections of medical device establishments.

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

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