GINETTE RHODES

FY 2014 Omnibus HR 3547, FY 2014 Continuing Resolution H J Res 106 PL 113-73 and H J Res 59 PL 113-67, and potential Medicare offsets that might be applied to prescription drugs in all of the issues listed.

FY 2014 Omnibus HR 3547; FY 2014 Continuing Resolution H J Res 106 PL 113-73 FY 2014 Continuing Resolution H J Res 59 PL 113-67; FY 2015 Budget, H Con Res 96 (no Senate Companion at this time) HJ Res 124 Continuing Appropriations Resolution, 2015In all of the above the specific issues included potential Medicare offsets that might be applied to prescription drugs. Labor/HHS/Ed Appropriations: National Institutes of Health, biodefense/pandemic, science/math education, and strategic stockpile funding and preparation; Food and Drug Administration Appropriations; Patent and Trademark Office Appropriations

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

Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care & 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, Health care reform implementation; the 340B program of the Health Resources & Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics.

Issues related to Medicare reimbursement of antibiotics; H.R. 4187, Developing Innovative Strategy for Antimicrobial Resistant Microorganisms HR 3402 Protecting Access to Medicare Act of 2014 Public Law No: 113-93 In all of the above the specific issues included Medicare offsets that might be applied to prescription drugs

Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care & 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, Health care reform implementation; the 340B program of the Health Resources & Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics.

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. 919 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. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints, antibiotic resistance, reimbursement issues for antibiotics, President's Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance, LPAD (Limited Population Antibacterial Drug) proposal

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/Title VIII of the Food & Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation, HR 3742 - the Antibiotic Development to Advance Patient Treatment of 2013, and HR 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; HR 3742- the Antibiotic Development to Advance Patient Treatment Act of 2013; H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014;antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

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

Implementation of the GAIN provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation HR 3742 the Antibiotic Development to Advance Patient Treatment Act of 2013 HR 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

Issues related to Medicare reimbursement of antibiotics; S. 2000 / H.R. 4015, The SGR Repeal & Medicare Provider Payment Modernization Act of 2014; H.R. 4302, Protecting Access to Medicare Act of 2014 and Public Law No. 113-93, and potential Medicare offsets that might be applied to prescription drugs in all issues listed.

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

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; HR 3742- the Antibiotic Development to Advance Patient Treatment Act of 2013; H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014;antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

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. 919 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. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints, antibiotic resistance, reimbursement issues for antibiotics, President's Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance, LPAD (Limited Population Antibacterial Drug) proposal

Issues related to Medicare reimbursement of antibiotics; H.R. 4187, Developing Innovative Strategy for Antimicrobial Resistant Microorganisms HR 3402 Protecting Access to Medicare Act of 2014 Public Law No: 113-93 In all of the above the specific issues included Medicare offsets that might be applied to prescription drugs

Implementation of the GAIN provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation HR 3742 the Antibiotic Development to Advance Patient Treatment Act of 2013 HR 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

HR 4302 Protecting Access to Medicare Act of 2014 - Public Law No: 113-93 In the above the specific issues included potential Medicare offsets that might be applied to prescription drugs H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014. Issues relating to Medicare reimbursement of antibioticsAddress concerns with Medicare Independent Payment Advisory Board (IPAB). Addresss concerns with changes to Medicare Part B and Part D programs, and 2015 Hospital Outpatient Prospective Payment System. Address concerns with Medicaid coverage of specialty drugs. Support creation of incentives for antibiotics development. Oppose changes to Medicare Advantage and Part D prescription drug benefit. Support Treat and Reduce Obesity Act.

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 Affordable Care Act's expansion of covered 340B entities. Support legislation increasing access to wireless technologies. FDA review process consistency and predictability. Address concerns with Medicare Independent Payment Advisory Board (IPAB).Address concerns with changes to Medicare Part B and Part D programs. Issues related to antibiotics and breakpoints. Ongoing 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. H.R. 4187, DISARM - Developing An Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014; President's Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance.

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/Title VIII of the Food & Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation, HR 3742 - the Antibiotic Development to Advance Patient Treatment of 2013, and HR 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

HR 4302 Protecting Access to Medicare Act of 2014 - Public Law No: 113-93 In the above the specific issues included potential Medicare offsets that might be applied to prescription drugs H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014. Issues relating to Medicare reimbursement of antibioticsAddress concerns with Medicare Independent Payment Advisory Board (IPAB). Addresss concerns with changes to Medicare Part B and Part D programs, and 2015 Hospital Outpatient Prospective Payment System. Address concerns with Medicaid coverage of specialty drugs. Support creation of incentives for antibiotics development. Oppose changes to Medicare Advantage and Part D prescription drug benefit. Support Treat and Reduce Obesity Act.

Issues related to Medicare reimbursement of antibiotics; S. 2000 / H.R. 4015, The SGR Repeal & Medicare Provider Payment Modernization Act of 2014; H.R. 4302, Protecting Access to Medicare Act of 2014 and Public Law No. 113-93, and potential Medicare offsets that might be applied to prescription drugs in all issues listed.

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. 919 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. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints, antibiotic resistance, reimbursement issues for antibiotics, President's Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance, LPAD (Limited Population Antibacterial Drug) proposal

Issues related to Medicare reimbursement of antibiotics; S. 2000 / H.R. 4015, The SGR Repeal & Medicare Provider Payment Modernization Act of 2014; H.R. 4302, Protecting Access to Medicare Act of 2014 and Public Law No. 113-93, and potential Medicare offsets that might be applied to prescription drugs in all issues listed.

Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care & 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, Health care reform implementation; the 340B program of the Health Resources & Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics.

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

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

Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care & 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, Health care reform implementation; the 340B program of the Health Resources & Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics.

S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014In all of the above the specific issues included potential Medicare offsets that might be applied to prescription drugs; issues related to Medicare reimbursement for new technologies

S. Con. Res. 8 - Concurrent Resolution on the Budget for Fiscal Year 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014In all of the above the specific issues included potential Medicare offsets that might be applied to prescription drugs

H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014, setting forth appropriate budgetary levels for FY 15 through 2033, potential Medicare offsets that might be applied to prescription drugs, and budget resolution S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014,potential Medicare offsets that might be applied to prescription drugs, budget resolution, issues concerning Medicare & Medicaid reimbursements, issues pertaining to the implementation of the federal budget sequester.

Issues related to Medicare reimbursement for new technologies in the following; S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014

H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014, setting forth appropriate budgetary levels for FY 15 through 2033, potential Medicare offsets that might be applied to prescription drugs, and budget resolution S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014,potential Medicare offsets that might be applied to prescription drugs, budget resolution, issues concerning Medicare & Medicaid reimbursements

Issues related to Medicare reimbursement for new technologies in the following; S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014

S. Con. Res 8 - Concurrent Resolution on the Budget for Fiscal Year 2014 H. Con. Res 25 - Establishing the budget for the US Government for FY 2014 and settling forth appropriate budgetary levels for FY 15 through 2033, budget resolution In all of the above the specific issues included potential Medicare offsets that might be applied to prescription drugsHR 933 Consolidated and Further Continuing Appropriations Act, 2013 Issues concerning Medicare & Medicaid reimbursements, issues pertaining to the implementation of the federal budget sequester

S. Con. Res 8 - Concurrent Resolution on the Budget for Fiscal Year 2014 H. Con. Res 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 15 through 2033 HR 933 - Consolidated and Further Continuing Appropriations Act, 2013In all of the above the specific issues included potential Medicare offsets that might be applied to prescription drugs

Issues related to Medicare reimbursement for new technologies in the following; S. Con. Res. 8 - Concurrent Resolution on the Budget for Fiscal Year 2014 H. Con. Res 25 - Establishing the budget for the US Government for fiscal Year 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H.J. Res. 59, Bipartisan Budget Act of 2013

Issues related to Medicare reimbursement for new technologies in the following; S. Con. Res. 8 - Concurrent Resolution on the Budget for Fiscal Year 2014 H. Con. Res 25 - Establishing the budget for the US Government for fiscal Year 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H.J. Res. 59, Bipartisan Budget Act of 2013

Implementation of the "GAIN" provision/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) (PL 112-144); antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: H. R. 1919 - Safeguarding America's Pharmaceutical Act of 2013,HR 3204 - Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

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 ACA's expansion of covered 340B entities.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 American Taxpayer Relief Act of 2012 (Pub. L. 112-240, H. R. 8) 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 and as they relate to the tracking and tracing of pharmaceutical drugs. Ongoing discussions surrounding next steps for protecting and promotiong incentives for the development of resistant pathogens including breakpoints Antibiotic resistance among elderly population H.R. 3204, The Drug Quality and Security Act and The Compounding Clarity Act of 2013

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

Implementation of the "GAIN" provisions/Title VIII of the Food & Drug Administration Safety & Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation (HR 1919 - Safeguarding America's Pharmaceutical Act of 2013)

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 ACA's expansion of covered 340B entities, issues concerning incenting antibiotic development; issues related to track and trace of pharmaceuticalsImplementation & Rule Making related to Generating Antibiotics Incentives Now (GAIN) Act (PL 112-144) and ongoing discussions surrounding next steps for protecting and promoting incentives for the developement of resistant pathogens including breakpoints Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Now (GAIN) Act (S.1734) 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 American Taxpayer Relief Act of 2012 Pub. L. 112-240, H.R. 8

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Implementation of the "GAIN" provision/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) (PL 112-144); antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: H. R. 1919 - Safeguarding America's Pharmaceutical Act of 2013,HR 3204 - Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

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 ACA's expansion of covered 340B entities.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 American Taxpayer Relief Act of 2012 (Pub. L. 112-240, H. R. 8) 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 and as they relate to the tracking and tracing of pharmaceutical drugs. Ongoing discussions surrounding next steps for protecting and promotiong incentives for the development of resistant pathogens including breakpoints Antibiotic resistance among elderly population H.R. 3204, The Drug Quality and Security Act and The Compounding Clarity Act of 2013

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Implementation of the "GAIN" provision/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) (PL 112-144); antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: H. R. 1919 - Safeguarding America's Pharmaceutical Act of 2013,HR 3204 - Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

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 ACA's expansion of covered 340B entities, issues concerning incenting antibiotic development; issues related to track and trace of pharmaceuticalsImplementation & Rule Making related to Generating Antibiotics Incentives Now (GAIN) Act (PL 112-144) and ongoing discussions surrounding next steps for protecting and promoting incentives for the developement of resistant pathogens including breakpoints Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Now (GAIN) Act (S.1734) 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 American Taxpayer Relief Act of 2012 Pub. L. 112-240, H.R. 8

Implementation of the GAIN provisions/Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive and limited population antibiotic product (LPAD) legislation; pharmaceutical trace and trace legislation and S. 622 Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 (specifically in regards to potential antibiotic-related provisions)

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

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 ACA's expansion of covered 340B entities.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 American Taxpayer Relief Act of 2012 (Pub. L. 112-240, H. R. 8) 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 and as they relate to the tracking and tracing of pharmaceutical drugs. Ongoing discussions surrounding next steps for protecting and promotiong incentives for the development of resistant pathogens including breakpoints Antibiotic resistance among elderly population H.R. 3204, The Drug Quality and Security Act and The Compounding Clarity Act of 2013

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

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 ACA's expansion of covered 340B entities.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 American Taxpayer Relief Act of 2012 (Pub. L. 112-240, H. R. 8) 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 and as they relate to the tracking and tracing of pharmaceutical drugs. Ongoing discussions surrounding next steps for protecting and promotiong incentives for the development of resistant pathogens including breakpoints Antibiotic resistance among elderly population H.R. 3204, The Drug Quality and Security Act and The Compounding Clarity Act of 2013

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

Implementation of the "GAIN" provision/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) (PL 112-144); antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: H. R. 1919 - Safeguarding America's Pharmaceutical Act of 2013,HR 3204 - Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act

Implementation of the Generating Antibiotics Incentives Now (GAIN) Act provisions/title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation or as packaged with/tied to pharmaceutical compounding legislation: HR. 1919- Safeguarding America's Pharmaceutical Act of 2013, HR 3204- Drug Quality and Security Act, HR 2186 VALID Compounding Act, and S. 959 Pharmaceutical Compounding Quality and Accountability Act; HR 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013

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 ACA's expansion of covered 340B entities, issues concerning incenting antibiotic development; issues related to track and trace of pharmaceuticalsImplementation & Rule Making related to Generating Antibiotics Incentives Now (GAIN) Act (PL 112-144) and ongoing discussions surrounding next steps for protecting and promoting incentives for the developement of resistant pathogens including breakpoints Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Now (GAIN) Act (S.1734) 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 American Taxpayer Relief Act of 2012 Pub. L. 112-240, H.R. 8

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 ACA's expansion of covered 340B entities, issues concerning incenting antibiotic development; issues related to track and trace of pharmaceuticalsImplementation & Rule Making related to Generating Antibiotics Incentives Now (GAIN) Act (PL 112-144) and ongoing discussions surrounding next steps for protecting and promoting incentives for the developement of resistant pathogens including breakpoints Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Now (GAIN) Act (S.1734) 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 American Taxpayer Relief Act of 2012 Pub. L. 112-240, H.R. 8

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

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 ACA's expansion of covered 340B entities.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 American Taxpayer Relief Act of 2012 (Pub. L. 112-240, H. R. 8) 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 and as they relate to the tracking and tracing of pharmaceutical drugs. Ongoing discussions surrounding next steps for protecting and promotiong incentives for the development of resistant pathogens including breakpoints Antibiotic resistance among elderly population H.R. 3204, The Drug Quality and Security Act and The Compounding Clarity Act of 2013

Healthcare Reform Implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints; antibiotic resistance among elderly population; issues related to 340B Drug Pricing Program; reimbursement issues for antibiotics Issues concerning incenting antibiotic development. H.R. 3204, The Drug Quality and Security Act and S. 959, The Pharmaceutical Quality, Security and Accountability Act as they relate to the tracking and tracing of pharmaceutical drugs; issues related to antibiotics and breakpoints. 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 American Taxpayer Relief Act of 2012 Pub.L 112-240, H.R. 8 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.

S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014In all of the above the specific issues included potential Medicare offsets that might be applied to prescription drugs; issues related to Medicare reimbursement for new technologies

Issues related to Medicare reimbursement for new technologies in the following; S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014

Issues related to Medicare reimbursement for new technologies in the following; S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014

S. Con. Res. 8 - Concurrent Resolution on the Budget for Fiscal Year 2014 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014 and setting forth appropriate budgetary levels for FY 2015 through 2033 H. J. Res. 59 - Continuing Appropriations Resolution, 2014In all of the above the specific issues included potential Medicare offsets that might be applied to prescription drugs

S. 1734/H.R. 2182, Generating Antibiotic Incentives Now Act (GAIN Act) - incentives for development of products to treat antibiotic-resistant infections, issues concerning technical clarifications. S. 3187, Food and Drug Adminitration Safety and Innovations Act - incentives for development of products to treat antibiotic-resistant infections H.R. 5651, Food and Drug Administration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H.J. Res. 117, Continuing Approprations Resolution Medical Research Antibiotic resistance issues Reauthorization of the Prescrition Drug User Fee Act Reauthorization of the Medical Device User Fee Act H.R. 1483, Drug and Safety Enhancement Act of 2011 Implementation of Patient Protaction and Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)

S. 3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act (S. 1734), issues concerning technical clarifications; issues related to track and trace of pharmaceuticals; issues concerning Patient Centered Outcomes Research Institute grants. 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) Technical changes to Food and Drug Administration Safety and Innovation Act (PL 112-144) Medical research Antibiotic resistance issues H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013 H.J. Res. 117, Continuing Appropriations Resolution

S. 1734/H.R. 2182, Generating Antibiotic Incentives Now Act (GAIN Act) - incentives for development of products to treat antibiotic-resistant infections, issues concerning technical clarifications. S. 3187, Food and Drug Adminitration Safety and Innovations Act - incentives for development of products to treat antibiotic-resistant infections H.R. 5651, Food and Drug Administration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H.J. Res. 117, Continuing Approprations Resolution Medical Research Antibiotic resistance issues Reauthorization of the Prescrition Drug User Fee Act Reauthorization of the Medical Device User Fee Act H.R. 1483, Drug and Safety Enhancement Act of 2011 Implementation of Patient Protaction and Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)

S. 3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act (S. 1734), issues concerning technical clarifications; issues related to track and trace of pharmaceuticals; issues concerning Patient Centered Outcomes Research Institute grants. 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) Technical changes to Food and Drug Administration Safety and Innovation Act (PL 112-144) Medical research Antibiotic resistance issues H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013 H.J. Res. 117, Continuing Appropriations Resolution

FDA legislation and regulatory implementation issues H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act (S.1734) Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Congressional deficit reduction negotiations and Deficit Reduction Commission, following passage of the Budget Control Act of 2011 (P.L. 112-25). H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act; H.R. 5651, Food and Drug Administration Reform Act of 2012, S.3187, Food and Drug Administration Safety and Innovation Act; issues pertaining to antibiotic incentives, drug safety pedigree, and drug supply chain. Medical research. Antibiotic resistance issues. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act Address concerns regarding uncertainty and unpredictability of FDA drug and device regulatory environment. Support drug and device user fee legislation. Address concerns with Medicare Independent Payment Advisory Board (IPAB).

Antibiotic resistance issues. Pay-for-delay proposals and generic issues. H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011. Prescription Drug User Fee Act reauthorization. S. 2516, Food and Drug Administration Safety and Innnovation Act. S. 2292, Patients' FDA Act S. 2289, Better Pharmaceuticals and Devices for Children Act of 2012. S. 1734 / H.R. 2182, Generating Antiobiotic Incentives Now Act (GAIN Act) - incentives for development of products to treat antibiotic-resistant infections; S. 3187, Food and Drug Administration Safety and Innovation Act - incentives for development of products to treat antibiotic-resistant infections; ADDENDUM for General Lobbying Issue Area: PHA - Pharmacy H.R. 5651, Food and Drug Administration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections

S.1734 / H.R. 2182, Generating Antibiotic Incentives Now Act (GAIN Act) Incentives for development of products to treat antibiotic-resistant infections Senate Working Draft of Prescription Drug User Fee Act (PDUFA) Pay-for-delay proposals and generic issues Prescription Drug User Fee Act reauthorization Issues pertaining to Antibiotic resistance

S.1734 / H.R. 2182, Generating Antibiotic Incentives Now Act (GAIN Act); Incentives for development of products to treat antibiotic-resistant infections Senate Working Drafts of Prescription Drug User Fee Act (PDUFA) Implementation of Issues of H.R. 3590 Issues pertaining to General health care coverage and reimbursement issues Issues pertaining to The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) Issues pertaining to Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Issues pertaining to Food and Drugs Administration legislation and regulatory implementation issues. Issues pertaining to Congressional deficit reduction negotiations and Deficit Reduction Commission, following passage of the Budget Control Act of 2011 (P.L. 112-25) Issues pertaining to Antibiotic Development, Antibiotic Resistance, and Medical Research Issues pertaining to drug shortages, and drug supply chain

Antibiotic resistance issues. Pay-for-delay proposals and generic issues. H.R. 2182/ S. 1734, Generating Antibiotic Incentives Now Act of 2011-incentives for development of products to treat antibiotic-resistant infections Prescription Drug User Fee Act reauthorization. H.R. 5651, Food and Drug Adminitration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections S. 2516, Food and Drug Administration Safety and Innovation Act. S. 3187, Food and Drug Administration Safety and Innovation Act.- incentives for development of products to treat antibiotic-resistant infections S. 2292, Patients' FDA Act S. 2289, Better Pharmaceuticals and Devices for Childrens Act of 2012 H.R. 6433, FDA User Fee Corrections Act of 2012

Antibiotic resistance issues in the following bills Pay-for-delay proposals and generic issues H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011 Prescription Drug User Fee Act Reauthorization H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 2516, Food and Drug Administration Safety and Innovation Act S. 3187, Food and Drug Administration Safety and Innovation Act S. 2292, Patients' FDA Act S. 2289, Better Pharmaceuticals and Devices for Children Act of 2012 H.R. 6433, FDA User Fee Corrections Act of 2012 H.R. 8, American Taxpayer Relief Act of 2012

H.R. 3630, the Temporary Payroll Tax Cut Continuation Action Issues related to Medicare home infusion and Medicaid reimbursements Issues pertaining to Part A Medicare reimbursement Issues pertaining to 340B H.R. 2195 / S. 1203, Medicare Home Infusion Therapy Coverage Act of 2011 H. Con. Res 112, Establishing the budget for the US Government for FY 2013 Issues pertaining to the implementation of Patient Protection and Affordable Care Act (Pub.L. 111-148) Issues pertaining to the implmentation of Health Care and Education Reconciliation Act of 2010 (Pub.L. 111-152)

Medicare home infusion and reimbusement issues 340B Drug Pricing program issues, including program expansion H.R. 2195/S. 1203, Medicare Home Infusion Therapy Coverage Act of 2011 H. Con. Res. 112, Establishing the budget for the US Government for FY 2013 (Medicare-related provisions) Pub. L. 111-148, Patient Protection and Affortable Care Act (implementation). Pub. L. 111-152, Health Care and Education Reconciliation Act of 2010 (implementation). H.R. 5194, Rural Hospital and Provider Equity and 340B Improvement Act of 2012. H.R. 5624, Rural Hospital and Provider Equity and 340B Improvement Act of 2012.

H.R. 8, the American Taxpayers Relief Act of 2012 and issues concerning Medicare reimbursements for Part B and D 340B drug pricing program issues, including program expansion H.R. 2195 / S. 1203, Medicare Home Infusion Therapy Coverage Act of 2011 Medicare home infusion and reimbursement issues H. Con. Res. 112, Establishing the budget for the US Government for FY 2013 (Medicare-related provisions) Pub. L. 111-148, Patient Protection and Affordable Care Act (implementation) Pub. L. 111-152, Health Care and Education Reconciliation Act of 2010 (implementation) H.R. 5194, Rural Hospital and Provider Equity and 340B Improvement Act of 2012 H.R. 5624, Rural Hospital and Provider Equity and 340B Improvement Act of 2012 H.R. 6684, Spending Reduction Act of 2012

Medicare home infusion and reimbursement issues. 340B issues. H.R. 2195 / S. 1203, Medicare Home Infusion Therapy Coverage Act of 2011. H. Con. Res 112, Establishing the budget for the US Government for FY 2013 (Medicare-related provisions). Pub. L. 111-148, Patient Protection and Affordable Care Act (implementation). Pub. L. 111-152, Health Care and Education Reconciliation Act of 2010 (implementation). H.R. 5194, Rural Hospital and Provider Equity and 340B Improvement Act of 2012. H.R. 5624, Rural Hospital and Provider Equity and 340B Improvement Act of 2012. Address concerns with Medicare Independent Payment Advisory Board (IPAB).

S.1734 / H.R. 2182, Generating Antibiotic Incentives Now Act (GAIN Act); Incentives for development of products to treat antibiotic-resistant infections Senate Working Drafts of Prescription Drug User Fee Act (PDUFA) Implementation of Issues of H.R. 3590 Issues pertaining to General health care coverage and reimbursement issues Issues pertaining to The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) Issues pertaining to Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Issues pertaining to Food and Drugs Administration legislation and regulatory implementation issues. Issues pertaining to Congressional deficit reduction negotiations and Deficit Reduction Commission, following passage of the Budget Control Act of 2011 (P.L. 112-25) Issues pertaining to Antibiotic Development, Antibiotic Resistance, and Medical Research Issues pertaining to drug shortages, and drug supply chain

Medicare home infusion and reimbusement issues 340B Drug Pricing program issues, including program expansion H.R. 2195/S. 1203, Medicare Home Infusion Therapy Coverage Act of 2011 H. Con. Res. 112, Establishing the budget for the US Government for FY 2013 (Medicare-related provisions) Pub. L. 111-148, Patient Protection and Affortable Care Act (implementation). Pub. L. 111-152, Health Care and Education Reconciliation Act of 2010 (implementation). H.R. 5194, Rural Hospital and Provider Equity and 340B Improvement Act of 2012. H.R. 5624, Rural Hospital and Provider Equity and 340B Improvement Act of 2012.

H.R. 8, the American Taxpayers Relief Act of 2012 and issues concerning Medicare reimbursements for Part B and D 340B drug pricing program issues, including program expansion H.R. 2195 / S. 1203, Medicare Home Infusion Therapy Coverage Act of 2011 Medicare home infusion and reimbursement issues H. Con. Res. 112, Establishing the budget for the US Government for FY 2013 (Medicare-related provisions) Pub. L. 111-148, Patient Protection and Affordable Care Act (implementation) Pub. L. 111-152, Health Care and Education Reconciliation Act of 2010 (implementation) H.R. 5194, Rural Hospital and Provider Equity and 340B Improvement Act of 2012 H.R. 5624, Rural Hospital and Provider Equity and 340B Improvement Act of 2012 H.R. 6684, Spending Reduction Act of 2012