Medical Device Safety Act

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill 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, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

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

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill 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, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill 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, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

- 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. - 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 - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety

H.R. 1215, Protecting Access to Care Act of 2017 H.R. 2163, Medical Device Guardians Act H.R. 2164, Medical Device Safety Act S. 974, Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 Proposed Regulation regarding labeling changes for approved drugs and biological products (78 Fed. Reg. 67,985-67,999, November 13, 2013) Various issues relating to Americans with Disabilities Act (P.L. 101-336) and websites; drug and medical device preemption; medical liability reform

Client expense: $5,160,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC)

Issues related to implementation of PL 115-52, the Food and Drug Administration Reauthorization Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 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 Issues related to diagnostics regulation 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 H.R. 5418 related to improving the Medical-Surgical Prime Vendor procurement program at the VA S. 1691 related to cybersecurity and government procurement Issues related to medical technology and the opioid crisis H.R. 6 related to the opioid crisis

Client expense: $740,386 · Firm income: Not reported

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill 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, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Issues related to implementation of PL 115-52, the Food and Drug Administration Reauthorization Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 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 Issues related to diagnostics regulation 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

Client expense: $1,050,000 · Firm income: Not reported

- 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 - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. - HR 5492, "MOTHER Act of 2018", regarding all provisions.

H.R. 1215, Protecting Access to Care Act of 2017 H.R. 2163, Medical Device Guardians Act H.R. 2164, Medical Device Safety Act Proposed Regulation regarding labeling changes for approved drugs and biological products (78 Fed. Reg. 67,985-67,999, November 13, 2013) Various issues relating to Americans with Disabilities Act (P.L. 101-336) and websites; drug and medical device preemption; medical liability reform

Client expense: $7,540,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Vice President of the U.S.

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to womens health issues. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administration action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). S. 404, A bill 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, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 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 H.R. 878 the Right to Try Act of 2017 Issues related to diagnostics regulation Issues related to diagnostics payment reform Issues related to cybersecurity for medical technology S. 1691 Internet of Things (IoT) Cybersecurity Improvement Act of 2017 H.R. 3985 Internet of Medical Things Resilience Partnership Act of 2017 H.R. 4163 and S. 2020 Cyber Shield Act of 2017 H.R. 4191 HHS Cybersecurity Modernization Act 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

Client expense: $1,010,000 · Firm income: Not reported

H.R. 1215, Protecting Access to Care Act of 2017 H.R. 2163, Medical Device Guardians Act H.R. 2164, Medical Device Safety Act Proposed Regulation regarding labeling changes for approved drugs and biological products (78 Fed. Reg. 67,985-67,999, November 13, 2013) Various issues relating to drug and medical device preemption; medical liability reform

Client expense: $7,040,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, White House Office

- 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

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to womens health issues. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administration action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). S. 404, A bill 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, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3921, HEALTHY KIDS Act.

- 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

H.R. 1215, Protecting Access to Care Act of 2017 H.R. 2163, Medical Device Guardians Act H.R. 2164, Medical Device Safety Act Proposed Regulation regarding labeling changes for approved drugs and biological products (78 Fed. Reg. 67,985-67,999, November 13, 2013) Various issues relating to drug and medical device preemption; medical liability reform

Client expense: $4,890,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

H.R.372, Competitive Health Insurance Reform Act of 2017 H.R.1215, Protecting Access to Care Act of 2017 H.R.2164, Medical Device Safety Act H.R.1652/S.670, Over-the-Counter Hearing Aid Act of 2017 S.41, Medicare Prescription Drug Price Negotiation Act of 2017 S.178, Elder Abuse Prevention and Prosecution Act S.934, FDA Reauthorization Act of 2017 Issues related to the repeal of the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148) Issues related to over-the-counter hearing aids Issues related to patient safety and antibiotic resistance Issues related to off label drugs and device marketing

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Transportation, Dept of (DOT)

H.R. 1215, Protecting Access to Care Act of 2017 H.R. 2163, Medical Device Guardians Act H.R. 2164, Medical Device Safety Act Proposed Regulation regarding labeling changes for approved drugs and biological products (78 Fed. Reg. 67,985-67,999, November 13, 2013) Various issues relating to drug and medical device preemption; medical liability reform

Client expense: $3,330,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE