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Safeguarding America's Pharmaceuticals Act of 2013
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
62pct
26d open
vs 5,821 other HR bills in the 113th — cohort avg 49d
No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
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Filing registrants (103)
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2016 · second_quarter · Pharmacy
HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Pharmacy
HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Pharmacy
HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Pharmacy
HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Pharmacy
HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| IL |
| Bradley Scott Schneider | Democratic | IL |
| Brett Guthrie | Republican | KY |
| David B. McKinley | Republican | WV |
| David G. Valadao | Republican | CA |
| Fred Upton | Republican | MI |
| Jackie Walorski | Republican | IN |
| Jim Matheson | Democratic | UT |
| John D. Dingell | Democratic | MI |
| John Shimkus | Republican | IL |
| Marc A. Veasey | Democratic | TX |
| Marsha Blackburn | Republican | TN |
| Michael C. Burgess | Republican | TX |
| Mike Rogers | Republican | MI |
| Pete Olson | Republican | TX |
| Tim Walberg | Republican | MI |
| Tom Latham | Republican | IA |
2015 · first_quarter · Pharmacy
HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · first_quarter · Health Issues
Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", HR 1919 "Safeguarding America's Pharmaceuticals Act", Implementation issues related to the Pharmaceutical Quality, Security and Accountability Act (P.L. 113-54), Pharma supply chain issues, Issues related to 340b program; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program
Client expense: $1,310,600 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · first_quarter · Health Issues
Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act(FDASIA) Pub.L. 112-144) H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act House Committee on Energy & Commerce 21st Century Cures initiative.
Client expense: Not reported · Firm income: $37,500
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions and prescription drug abuse. 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 7.Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8.Healthier Lifestyles and Prevention America Act (S. 39) 9.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392/H.R. 2160) 10.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 11.Personal Health Investment Today Act (H.R. 956) 12.A bill to provide for a sequester replacement (S. 16/S. 799) 13.American Family Economic Protection Act of 2013 (S. 388) 14.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933/Public Law 113-6) 15.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 16.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 17.Physical Activity Guidelines for Americans Act (S. 531/H.R. 2179) 18.Firearm Safety and Public Health Research Act (H.R. 321) 19.Energy Consumers Relief Act (S. 1363/H.R. 1582) 20.Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) 21.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 22.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 23.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 24.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 25.FIT Kids Act (S. 1033/H.R. 2178) 26.Strengthening Americas Schools Act (S. 1094) 27.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 28.Fit to Serve Act (S. 976) 29.Climate Change Health Protection and Promotion Act (H.R. 2023/S. 2864) 30.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 31.Student Success Act (H.R. 5) 32.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 33.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 34.Senate FY14 Labor, Health and Human Services, and Education Bill (S. 1284) 35.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 36.Pharmacy Compounding Quality and Accountability Act (S. 959) 37.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 38.Implementation of Drug Supply Chain Security Act (P.L. 113-54) 39.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 40.Healthy Families Act (H.R. 1286/S. 631) 41.FY2014 Continuing Resolution (H.J. Res. 59) 42.Pharmaceutical Quality, Security and Accountability Act (S. 959) 43.Energy Consumers Relief Act (S. 1363/H.R. 1582) 44.Increasing the Safety of Prescription Drug Use Act (S. 1657) 45.National Energy Tax Repeal Act (S. 1324) 46.Saving Coal Jobs Act of 2013 (S. 1514/H.R. 5077) 47.Community Parks Revitalization Act (H.R. 2424) 48.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 49.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 50.Nutrition Reform and Work Opportunity Act (H.R. 3102) 51.Health Equity and Accountability Act (H.R. 5294) 52.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 53.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 54.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 55.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 56.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102, Public Law 113-79) 57.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 58.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 59.The Consolidated Appropriations Act of 2014 (H.R. 3547/Public Law 113-76 60.Strategies to Address Antimicrobial Resistance (STAAR) Act (S. 2236/H.R. 2285) 61.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 62.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 63.Electricity Security and Affordability Act (S. 1905/H.R. 3826) 64.Stop Overdose Stat Act (HR 4169) 65.Overdose Prevention Act (S 2755) 66.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 67.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4187) 68.Child Care and Development Block Grant Act of 2014 (S. 1086) 69.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill (including H.R. 5464) 70.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 71.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 (including H.R. 5171) 72.MAP-21 Reauthorization Act (S. 2322) 73.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 74.ENRICH Act (H.R. 4427) 75.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 76.Summer Meals Act of 2014 (S. 2527/HR. 5012) 77.Long-Term SCORE Act (H.R. 4444) 78.American Cures Act (S. 2115/H.R. 4384) 79.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 80.Fit for Life Act of 2014 (H.R.4765) 81.School Food Modernization Act (S. 2210/H.R. 1783) 82.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 83.Pedestrian Safety Act of 2014 (S. 2284) 84.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 85.Time for Recovery Enhancement for Addiction Treatment Act (S. 2645) 86.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (including H.R. 5016) 87.Vector-Borne Disease Research Accountability and Transparency Act (H.R. 4701) 88.Highway and Transportation Funding Act of 2014 (H.R. 5021/Public Law 113-159) 89.Full-Service Community Schools Act of 2014 (H.R. 5168) 90.PREPARE Act of 2014 (H.R. 5314) 91.Waters of the United States Regulatory Overreach Protection Act of 2014 (S. 2496/H.R. 5078) 92.American Energy Solutions for Lower Costs and More American Jobs Act (H.R. 2) 93.FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act (H.R. 83/Public Law 113-234) 94.Promise for Antibiotics and Therapeutics for Health Act (PATH Act, S. 2996) 95.Infectious Disease Hospital Hubs Act (S. 2942)
Client expense: $39,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)
2014 · fourth_quarter · Health Issues
Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act(FDASIA) Pub.L. 112-144) H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act House Committee on Energy & Commerce 21st Century Cures initiative.
Client expense: Not reported · Firm income: $54,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
Issues relating to bioequivalence and related administrative procedures. Issues relating to prescription drug abuse. Issues relating to incentives for tamper-resistant formulations. H.R. 486: Stop Tampering of Prescription Pills Act of 2013.Issues relating to Medicare Part D rebates. Issues relating to health information technology. H.R. 1919: Safeguarding Americas Pharmaceuticals Act of 2013. Compounding and drug supply chain legislation. H.R. 3204: Drug Quality and Security Act. Issues relating to products containing high doses of acetaminophen. Issues relating to the labeling of generic drugs. Issues relating to eliminating Medicare coverage for vacuum erection systems.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Pharmacy
H.R. 2835, S. 1647 - Restoring Access to Medication ActS.622, H.R. 1407, H.R. 1408, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 H.R.1150, S. 1256: Preservation of Antibiotics for Medical Treatment Act of 2013 H.R. 1919 Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3204 Drug Quality and Security Act
Client expense: $130,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE
2014 · fourth_quarter · Pharmacy
Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Pharmacy
S.644, Preventing Abuse of Cough Treatments Act of 2013 S. 621, Safe Prescribing Act of 2013 H.R. 1285, Safe Prescribing Act of 2013 H.R. 1919 Safeguarding America's Pharmaceuticals Act of 2013 S 959, Pharmaceutical Compounding Quality and Accountability Act S 1277, Combating Prescription Drug Abuse Act S.957, Drug Supply Chain Security Act H.R.3204 - Drug Quality and Security Act H.R. 4437 - Generic Drug Pricing Fairness Act
Client expense: $460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2014 · fourth_quarter · Health Issues
Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013; House Energy & Commerce Committee's 21st Century Cures initiative
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Pharmacy
Prescription Drug Abuse, STOPP Act HR486; S.Con.Res.8 (FY 2014 Budget) (provisions relating to healthcare and pharmeceuticals); Drug labeling, electronic labeling proposals; counterfeit drugs; HR 1919, Safeguarding America's Pharmaceuticals Act, and S.959, Pharmaceutical Quality, Security and Accountability Act; H. 3717 Helping Families in Mental Health Crisis Act of 2013; HR4800, FY15 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies;HR 2985, Combinaation Drug Development Incentive Act of 2013; and "21st Century Cures."
Client expense: $890,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office
2014 · fourth_quarter · Health Issues
Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics; Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
Client expense: $1,090,200 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
HR 1919 - Safeguarding America's Pharmaceuticals Act of 2013 S. 959 Pharmaceutical Quality, Security, and Accountability Act S. 957 Drug Supply Chain Security Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Pharmacy
H.R.800 & S.806 Medicare Prompt Pay Discount Exclusion (H.R.800 & S.806), legislation to ensure more appropriate general payment amount for drugs & biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. Cancer Patient Protection Act of 2013 (H.R.1416), legislation to exclude cancer drugs from sequestration cuts. Prescription Drug Abuse Legislation (H.R.1919, H.R.3204, S.957 & S.959)
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Pharmacy
H.R. 800 & S. 806 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. H.R. 1416 Cancer Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts.H.R. 1919, H.R. 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding. Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Pharmacy
Legislation and policies relating to: FDA Drug Safety and Risk Management Advisory Committee January 25 recommendation to reschedule hydrocodone as a Schedule II controlled substance H.R. 1285 - To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug H.R. 1919 - Safeguarding Americas Pharmaceuticals Act S. 621 - Safe Prescribing Act S. 959 - Pharmaceutical Compounding Quality and Accountability Act H.R. 3089 - Compounding Clarity Act H.R. 3204 - Drug Quality and Security Act (Public Law 113-54) H.R 4069 - Ensuring Patient Access and Effective Drug Enforcement Act
Client expense: Not reported · Firm income: $23,450
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2014 · fourth_quarter · Health Issues
Technology research; telemedicine and connected care; remote patient monitoring; community health centers and school health; implementation of Patient Protection and Affordable Care Act (H.R. 3590/P.L. 111-148); Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); the Protect Medical Innovation Act (H.R. 523); accountable care organizations; implementation of S. 3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919); SGR reform; FY 2015 budget; Protecting Access to Medicare Act (H.R. 4302); Common Sense Medicare SGR Repeal and Beneficiary Access Improvement Act (S. 2157); Sunshine Act/Open Payment implementation
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
Issues relating to bioequivalence and related administrative procedures; issues relating to prescription drug abuse; issues relating to incentives for tamper-resistant formulations; H.R. 486 (Stop Tampering of Prescription Pills Act of 2013); issues relating to Medicare Part D rebates; issues relating to health information technology; H.R. 1919 (Safeguarding America's Pharmaceuticals Act of 2013); compounding and drug supply chain legislation; H.R. 3204 (Drug Quality and Security Act); issues relating to products containing high doses of acetaminophen; issues relating to the labeling of generic drugs; issues relating to eliminating Medicare coverage for vacuum erection systems; FDA Proposed Generic Drug Labeling Rule.
Client expense: $540,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
S. 959, "Pharmaceutical Compounding Quality and Accounting Act" H.R. 1416, "Cancer Patient Protection Act of 2013" S. 957, "Drug Supply Chain Security" H.R. 1919, " Safeguarding America's Pharmaceuticals Act"
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
S. 959, "Pharmaceutical Compounding Quality and Accounting Act" H.R. 1416, "Cancer Patient Protection Act of 2013" S. 957, "Drug Supply Chain Security" H.R. 1919, " Safeguarding America's Pharmaceuticals Act"
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
Public Law 112-144 - Implementation Food and Drug Administration Safety and Innovation Act FDASIA H.R. 1919 - Safeguarding Pharmaceuticals Act of 2013 - Track and Trace Pedigree Program S. 957 - Drug Supply Chain Security Act - Track and Trace Pedigree Program H.R. 3204 - Drug Quality & Security Act - Became Public Law 113-54 - Track and Trace Pedigree Program Unique Device Identifiers (UDI) Implementation of UDI Rule 21st Century Cares Initiative - Draft legisation to accelerate the pace of biomedical Innovation and curs by Modernizing Federal Research and Regulatory Agencies
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · fourth_quarter · Health Issues
Issues relating to bioequivalence and related administrative procedures. Issues relating to prescription drug abuse. Issues relating to incentives for tamper-resistant formulations. H.R. 486 - Stop Tampering of Prescription Pills Act of 2013. Issues relating to Medicare Part D rebates. Issues relating to health information technology. H.R. 1919 - Safeguarding Americas Pharmaceuticals Act of 2013.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Pharmacy
Legislation and policies relating to: FDA Drug Safety and Risk Management Advisory Committee January 25 recommendation to reschedule hydrocodone as a Schedule II controlled substance H.R. 1285 - To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug H.R. 1919 - Safeguarding Americas Pharmaceuticals Act S. 621 - Safe Prescribing Act S. 959 - Pharmaceutical Compounding Quality and Accountability Act H.R. 3089 - Compounding Clarity Act H.R. 3204 - Drug Quality and Security Act (Public Law 113-54) H.R 4069 - Ensuring Patient Access and Effective Drug Enforcement Act
Client expense: Not reported · Firm income: $23,450
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2014 · third_quarter · Pharmacy
HR 800 & S. 806 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Cancer Patient Protection Act of 2013, legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding. Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; and community-based public health interventions and prescription drug abuse. 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148)2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 7.Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8.Healthier Lifestyles and Prevention America Act (S. 39) 9.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392/H.R. 2160) 10.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 11.Personal Health Investment Today Act (H.R. 956) 12.A bill to provide for a sequester replacement (S. 16/S. 799) 13.American Family Economic Protection Act of 2013 (S. 388) 14.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933/Public Law 113-6) 15.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 16.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 17.Physical Activity Guidelines for Americans Act (S. 531/H.R. 2179) 18.Firearm Safety and Public Health Research Act (H.R. 321) 19.Energy Consumers Relief Act (S. 1363/H.R. 1582) 20.Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) 21.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 22.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 23.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 24.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 25.FIT Kids Act (S. 1033/H.R. 2178) 26.Strengthening Americas Schools Act (S. 1094) 27.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 28.Fit to Serve Act (S. 976) 29.Climate Change Health Protection and Promotion Act (H.R. 2023/S. 2864) 30.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 31.Student Success Act (H.R. 5) 32.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 33.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 34.Senate FY14 Labor, Health and Human Services, and Education Bill (S. 1284) 35.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 36.Pharmacy Compounding Quality and Accountability Act (S. 959) 37.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 38.Implementation of Drug Supply Chain Security Act (P.L. 113-54) 39.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 40.Healthy Families Act (H.R. 1286/S. 631) 41.FY2014 Continuing Resolution (H.J. Res. 59) 42.Pharmaceutical Quality, Security and Accountability Act (S. 959) 43.Energy Consumers Relief Act (S. 1363/H.R. 1582) 44.Increasing the Safety of Prescription Drug Use Act (S. 1657) 45.National Energy Tax Repeal Act (S. 1324) 46.Saving Coal Jobs Act of 2013 (S. 1514/H.R. 5077) 47.Community Parks Revitalization Act (H.R. 2424) 48.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 49.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 50.Nutrition Reform and Work Opportunity Act (H.R. 3102) 51.Health Equity and Accountability Act (H.R. 5294) 52.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 53.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 54.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 55.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 56.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102, Public Law 113-79) 57.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 58.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 59.The Consolidated Appropriations Act of 2014 (H.R. 3547/Public Law 113-76 60.Strategies to Address Antimicrobial Resistance (STAAR) Act (S. 2236/H.R. 2285) 61.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 62.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 63.Electricity Security and Affordability Act (S. 1905/H.R. 3826) 64.Stop Overdose Stat Act (HR 4169) 65.Overdose Prevention Act (S 2755) 66.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 67.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4187) 68.Child Care and Development Block Grant Act of 2014 (S. 1086) 69.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill (including H.R. 5464) 70.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 71.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 (including H.R. 5171) 72.MAP-21 Reauthorization Act (S. 2322) 73.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 74.ENRICH Act (H.R. 4427) 75.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 76.Summer Meals Act of 2014 (S. 2527/HR. 5012) 77.Long-Term SCORE Act (H.R. 4444) 78.American Cures Act (S. 2115/H.R. 4384) 79.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 80.Fit for Life Act of 2014 (H.R.4765) 81.School Food Modernization Act (S. 2210/H.R. 1783) 82.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 83.Pedestrian Safety Act of 2014 (S. 2284) 84.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 85.The Recovery Enhancement for Addiction Treatment Act (S. 2645) 86.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (including H.R. 5016) 87.Vector-Borne Disease Research Accountability and Transparency Act (H.R. 4701) 88.Highway and Transportation Funding Act of 2014 (H.R. 5021/Public Law 113-520) 89.Full-Service Community Schools Act of 2014 (H.R. 5168) 90.PREPARE Act of 2014 (H.R. 5314) 91.Waters of the United States Regulatory Overreach Protection Act of 2014 (S. 2496/H.R. 5078) 92.American Energy Solutions for Lower Costs and More American Jobs Act (H.R.
Client expense: $38,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)
2014 · third_quarter · Pharmacy
Prescription Drug Abuse, STOPP Act HR486; S.Con.Res.8 (FY 2014 Budget) (provisions relating to healthcare and pharmeceuticals); Drug labeling, electronic labeling proposals; counterfeit drugs; HR 1919, Safeguarding America's Pharmaceuticals Act, and S.959, Pharmaceutical Quality, Security and Accountability Act; H. 3717 Helping Families in Mental Health Crisis Act of 2013; HR4800, FY15 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies;HR 2985, Combinaation Drug Development Incentive Act of 2013; and "21st Century Cures."
Client expense: $880,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office
2014 · third_quarter · Pharmacy
S. 644 - Preventing Abuse of Cough Treatments Act of 2013 H.R. 2835, S. 1647 - Restoring Access to Medication ActS.622, H.R. 1407, H.R. 1408, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 H.R.1150, S. 1256: Preservation of Antibiotics for Medical Treatment Act of 2013 H.R. 1919 Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3204 Drug Quality and Security Act
Client expense: $140,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE
2014 · third_quarter · Pharmacy
H.R.800 & S.806 Medicare Prompt Pay Discount Exclusion (H.R.800 & S.806), legislation to ensure more appropriate general payment amount for drugs & biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. Cancer Patient Protection Act of 2013 (H.R.1416), legislation to exclude cancer drugs from sequestration cuts. Prescription Drug Abuse Legislation (H.R.1919, H.R.3204, S.957 & S.959)
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
Issues relating to bioequivalence and related administrative procedures. Issues relating to prescription drug abuse. Issues relating to incentives for tamper-resistant formulations. H.R. 486: Stop Tampering of Prescription Pills Act of 2013.Issues relating to Medicare Part D rebates. Issues relating to health information technology. H.R. 1919: Safeguarding Americas Pharmaceuticals Act of 2013. Compounding and drug supply chain legislation. H.R. 3204: Drug Quality and Security Act. Issues relating to products containing high doses of acetaminophen. Issues relating to the labeling of generic drugs.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES
2014 · third_quarter · Health Issues
Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) Pub.L. 112-144) H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act
Client expense: Not reported · Firm income: $54,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Pharmacy
S.644, Preventing Abuse of Cough Treatments Act of 2013 S. 621, Safe Prescribing Act of 2013 H.R. 1285, Safe Prescribing Act of 2013 H.R. 1919 Safeguarding America's Pharmaceuticals Act of 2013 S 959, Pharmaceutical Compounding Quality and Accountability Act S 1277, Combating Prescription Drug Abuse Act S.957, Drug Supply Chain Security Act H.R.3204 - Drug Quality and Security Act H.R. 4437 - Generic Drug Pricing Fairness Act
Client expense: $480,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2014 · third_quarter · Health Issues
HR 1919 - Safeguarding America's Pharmaceuticals Act of 2013 S. 959 Pharmaceutical Quality, Security, and Accountability Act S. 957 Drug Supply Chain Security Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Pharmacy
Issues related to bioequivalence and related administrative procedures; issues related to prescription drug abuse; issues related to the labeling of generic drugs; issues related to tamper resistant formulation of pharmaceutical drugs. The Life Sciences Jobs and Investment Act; Issues relating to Medicare Part D rebates; H.R. 486 - Stop Tampering of Prescription Pills Act of 2013; H.R. 1919 - Safeguarding Americas Pharmaceuticals Act of 2013
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
Technology research; community health centers and school health; telemedicine; implementation of Patient Protection and Affordable Care Act (H.R. 3590/P.L. No. 111-148); Health Care and Education Reconciliation Act (H.R. 4872/P.L. No. 111-152); the Protect Medical Innovation Act (H.R. 523); accountable care organizations; implementation of S. 3187, the Food and Drug Administration Safety and Inovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919); SGR reform; FY 2015 budget;Protecting Access to Medicare Act (H.R. 4302); Common Sense Medicare SGR Repeal and Beneficiary Access Improvement Act (S. 2157); Sunshine Act/Open Payment implementation
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals; Medical Countermeasure Stockpile 340B Drug Discounting Program; FOR - Issues related to the treatment of biologics in international health programs specifically under the Pan American Health Organization
Client expense: $1,079,232 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Pharmacy
Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013; House Energy & Commerce Committee's 21st Century Cures initiative
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
Public Law 112-144 - Implementation Food and Drug Administration Safety and Innovation Act FDASIA H.R. 1919 - Safeguarding Pharmaceuticals Act of 2013 - Track and Trace Pedigree Program S. 957 - Drug Supply Chain Security Act - Track and Trace Pedigree Program H.R. 3204 - Drug Quality & Security Act - Became Public Law 113-54 - Track and Trace Pedigree Program Unique Device Identifiers (UDI) Implementation of UDI Rule
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
S.959, "Pharmaceutical Compounding Quality and Accounting Act" H.R. 1416, "Cancer Patient Protection Act of 2013" S.957, "Drug Supply Chain Security" H.R. 1919, "Safeguarding America's Pharmaceuticals Act"
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · third_quarter · Health Issues
Issues relating to bioequivalence and related administrative procedures; issues relating to prescription drug abuse; issues relating to incentives for tamper-resistant formulations; H.R. 486 (Stop Tampering of Prescription Pills Act of 2013); issues relating to Medicare Part D rebates; issues relating to health information technology; H.R. 1919 (Safeguarding America's Pharmaceuticals Act of 2013); compounding and drug supply chain legislation; H.R. 3204 (Drug Quality and Security Act); issues relating to products containing high doses of acetaminophen; issues relating to the labeling of generic drugs.
Client expense: $270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · second_quarter · Pharmacy
H.R. 800 & S. 806 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. H.R. 1416 Cancer Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts.H.R. 1919, H.R. 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding. Legislation pertaining to drug manufacturing shortages.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2014 · second_quarter · Pharmacy
Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - implementation issues related to reauthorization of user fees for prescription drug, medical device, and biologics approval - Regulation of online pharmacies and prescription painkillers. Prescriber Education and CME TrainingH.R. 1919 - Safeguarding America's Pharmaceuticals Act of 2013 - drug shortage issues. S. 959 - Pharmaceutical Compounding Quality and Accountability Act - drug shortage issues, prescriber education and CME training. H.R. 2186 - Valid Compounding Act - drug shortage issues H.R. 1919 - Safeguarding America's Pharmaceuticals Act of 2013- drug shortage issues H.R. 3089 - the Compounding Clarity Act - drug shortage issues. Public Law 113-54 - the Drug Quality and Security Act - drug shortage issues. FDA and HHS recommendations for rescheduling certain drugs. H.R. 4800/S. 2389, Agriculture FDA Appropriations for FY 2015
Client expense: Not reported · Firm income: $75,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2014 · second_quarter · Health Issues
Health care reform implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing program issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACAs expansion of covered 340B entitiesOngoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints Antibiotic resistance among elderly population Reimbursement issues for antibiotics HR 4187, DISARM, Developing Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub.L. 112-144) S. 957, Drug Supply Chain Security Act; H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 S. 959, Pharmaceutical Compounding Quality and Accountability Act H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act
Client expense: $380,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE