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A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.
Legislative Progress
Introduced
February 15, 2017
Latest Action
February 15, 2017
Primary Sponsor
Johnny IsaksonRepublican(GA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 3,805 other S bills in the 115th — cohort avg 41d
This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding Food and Drug Administration (FDA): (1) inspections of establishments that manufacture or process medical devices, and (2) certification of medical devices for export. The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing the risk-based schedule, the FDA must consider an establishment's participation in international medical device audit programs. The FDA must adopt a uniform process and uniform standards for inspections of domestic and foreign medical device establishments. Upon request, the FDA must provide to the person in charge of a medical device establishment feedback regarding the person's proposals to address issues identified during an inspection. The FDA must provide the basis for denying requests for certification of products for export as meeting FDA requirements for domestic products. A person denied such a certification may request supervisory review of that decision. Products from a medical device establishment that an inspector found to be contaminated or insanitary may be certified for export if the person in charge of the establishment has agreed to a plan to correct the issues identified during the inspection.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (11)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · fourth_quarter · Health Issues
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: $1,320,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), 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
2018 · fourth_quarter · Health Issues
- 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 - 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 - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions - H.R. 1318, "Preventing Maternal Deaths Act of 2018", regarding all provisions
2018 · third_quarter · Health Issues
- 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 - 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 - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions
2018 · second_quarter · Health Issues
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.
2018 · third_quarter · Health Issues
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: $2,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
Client expense: $1,980,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
Client expense: $1,700,000 · 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
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
2018 · third_quarter · Clean Air and Water (quality)
EPA's Clean Water Rule, Farm Bill (H.R.2), Appropriations (H.R.6147, H.R.6258, H.R.5895, and H.R.6157), EPA's 404(c) rulemaking, WRDA (S.3021), EPA's Lead and Copper Rule; Water Resources Development Act - ensuring safe drinking water provisions were including; letter to Senate Leadership in favor of bill; Clean Cars - testimony for field hearings; thanks yous for member testimony; guidance for staff on how to handle particular members; environmental defense specific to appropriations and avoiding poison pill riders, including signing on to letters and individual interactions.
Client expense: $10,000 · Firm income: Not reported
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
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: $1,670,000 · 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
2018 · first_quarter · Health Issues
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: $3,420,000 · 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
2018 · second_quarter · Health Issues
- 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
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · first_quarter · Health Issues
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: $3,450,000 · 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
2018 · first_quarter · Health Issues
- 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.
Client expense: $1,370,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2017 · fourth_quarter · Health Issues
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.
Client expense: $2,140,000 · 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
2017 · fourth_quarter · Health Issues
- 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
2017 · third_quarter · Health Issues
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.
Client expense: $1,840,000 · 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
2017 · third_quarter · Health Issues
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
Client expense: $760,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Health Issues
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
2017 · third_quarter · Health Issues
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)
2017 · third_quarter · Health Issues
- 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
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2017 · third_quarter · Health Issues
Legislation and FDA regulation concerning medical device development, manufacturing, commercialization, and post-market regulation and activities. S. 404 - A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications. H.R. 2430/S.934 FDA Reauthorization Act of 2017.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Health Issues
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
2017 · third_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors Opposing the imposition of price controls in the Medicare program Generally supporting intellectual property rights Generally supporting the full repeal of the medical device excise tax Supporting improvements to the FDA's medical device inspection process, specifically S. 404 and H 1736 Supporting the OPEN ACT, HR. 1223 and companion legislation in the Senate to be introduced Opposing S. 771 and HR 1776. Supporting the repeal of the Independent Payment Advisory Board, specifically HR 849 and S 251.
Client expense: $59,519 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
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)
2017 · second_quarter · Health Issues
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. 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. 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.
Client expense: $2,120,000 · 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
2017 · second_quarter · Health Issues
Legislation and FDA regulation concerning medical device development, manufacturing, commercialization, and post-market regulation and activities. S. 404 - A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications. H.R. 1628 - American Health Care Act of 2017. H.R. 2430/S.934 FDA Reauthorization Act of 2017.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
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)
2017 · second_quarter · Health Issues
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
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
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
2017 · second_quarter · Health Issues
- 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
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2017 · second_quarter · Health Issues
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
2017 · second_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors Opposing the imposition of price controls in the Medicare program Generally supporting intellectual property rights Generally supporting the full repeal of the medical device excise tax Opposing the importation of medicines, specifically HR 1245 and S. 469 Supporting improvements to the FDA's medical device inspection process, specifically S. 404 and H 1736 Supporting the OPEN ACT, HR. 1223 and companion legislation in the Senate to be introduced Opposing S. 771 and HR 1776. Supporting the repeal of the Independent Payment Advisory Board, specifically HR 849 and S 251.
Client expense: $56,199 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
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
2017 · first_quarter · Health Issues
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. 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. 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.
Client expense: $2,450,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office
2017 · first_quarter · Health Issues
Legislation and FDA regulation concerning medical device development, manufacturing, commercialization, and post-market regulation and activities. S. 404 - A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
- 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
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2017 · first_quarter · Health Issues
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
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
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
2017 · first_quarter · Taxation/Internal Revenue Code
- Support lower rates on taxation of dividends. - Tax reform proposals. - Tax extenders. - Promote the development of the natural gas vehicle market by supporting various incentives. H.R. 1090 - Technology for Energy Security Act of 2017. S. 404 - Waterway LNG Parity Act of 2017 H.R. 1686, Amending the Internal Revenue Code of 1986 to extend the limitation on the carryover of excess corporate charitable contributions by regulated public utilities; H.R. 761, The Pension and Budget Integrity Act; S. 270, The Pension and Budget Integrity Act; S. 540, Mobile Workforce State Income Tax Simplification Act of 2017; H.R. 1393, Mobile Workforce State Income Tax Simplification Act of 2017; H.R. 238, Commodity End-User Relief Act, End-user protections; American Business Competitiveness Act;
Client expense: $350,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE
2017 · first_quarter · Health Issues
H.R. 184, Protect Medical Innovation Act of 2017 S. 108, Medical Device Access & Innovation Protection Act Policies promoting medical innovation Medical Device User Fees Postmarket Surveilance S. 404, FDA Inspection Process Heart Valve Disease Awareness
Client expense: $230,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors Opposing the imposition of price controls in the Medicare program Generally supporting intellectual property rights Generally supporting the full repeal of the medical device excise tax Opposing the importation of medicines, specifically HR 1245 and S. 469 Supporting improvements to the FDA's medical device inspection process, specifically S. 404 Supporting the OPEN ACT, HR. 1223 and companion legislation in the Senate to be introduced
Client expense: $68,426 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE