Ensuring Patient Access and Effective Drug Enforcement Act of 2013

H.R. 4069 & S. 2862 (Ensuring Patient Access and Effective Drug Enforcement Act)

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 ***, no specific bills, drug safety

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum pageImportation of prescription drugs (H.R. 3715, S. 2549) Rx Pedigree (PL 113-54) Prescription Drug Monitoring Programs Counterfeit Drugs Prescription Drug Abuse - General issues related to Rx drug abuse (S. 348, S. 1277, H.R. 4069, H.R. 4709, S. 2862), Hydrocodone Rescheduling (H.R. 1285, S. 621)

Client expense: Not reported · Firm income: $80,000

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

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to Risk Evaluation and Mitigation Strategies (REMS) H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act: Provisions related to expanded access and compassionate use S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) S. 2917, Adding Ebola to the FDA Priority Review Voucher Program: Provisions related to new proposed voucher program; Public Law No. 113-233 Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Branded Prescription Drug Fee policy issues (79 Fed. Reg. 43631 (July 28, 2014)) 21st Century Cures legislation and policy issues R&D tax credit renewal as part of H.R. 5771, Tax Increase Prevention Act of 2014 Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA expedited drug approval policy issues Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products [Docket No. FDA-2013-N-0500]: Patient labeling Issues relating to communications about prescription drugs 340B program policy issues Importation policy issues Clinical trial policy issues

Client expense: $3,960,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 2575, Save American Workers Act; H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement; S. 2862, Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014; Implementation issues related to the Patient Protection and Affordable Care Act (P.L. 111-148).

Client expense: $470,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.4069, Ensuring Patient Access and Effective Drug Enforcement Act of 2013, Monitor drug enforcement related issues.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Issues concerning prescription drug abuse related to H.R. 3392, the "Medicare Part D Patient Safety & Drug Abuse Prevention Act;" H.R. 4069, the "Ensuring Patient Access & Effective Drug Enforcement Act of 2014;" and Protecting Integrity in Medicare Act (discussion draft).

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Rx Pedigree (Public Law 113-54); Prescription Drug Monitoring Programs; Prescription Drug Abuse - General issues related to Rx drug abuse, (S. 348, S. 1277, H.R. 4069, H.R. 4709, S. 2862), Hydrocodone Rescheduling (H.R. 1285, S. 621); Counterfeit Drugs; Importation of Prescription Drugs

Client expense: $257,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

All legislative and executive actions concerning healthcare reform, including provisions related to medication therapy management (MTM), pharmacy dispensing fees, drug safety, prescription drug diversion and abuse, drug shortages, supply chain, Medicare Sustainable Growth Rate, Medicaid reimbursement, and provider status S. 557 - Medication Therapy Management Empowerment Act of 2013 H.R. 1024 - Medication Therapy Management Empowerment Act of 2013 H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 S. 1277 - Combating Prescription Drug Abuse Act H.R. 4190 - Improved Patients' Access to Pharmacist Services

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

H.R. 4069 & S. 2862 (Ensuring Patient Access and Effective Drug Enforcement Act)

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to DEA scheduling S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking 21st Century Cures legislation and policy issues Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

Client expense: $3,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 2575, Save American Workers Act; H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement; S. 2862, Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014; Implementation issues related to the Patient Protection and Affordable Care Act (P.L. 111-148).

Client expense: $130,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to prescription drug abuse, pharmacist provider status, drug pricing and drug supply chain safety. HR 4190-Medicare Patient Access to Pharmacy Services in Medically Underserved Communities HR 4069-Ensuring Patient Access and Effective Drug Enforcement Act of 2013

Client expense: $4,290,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

Rx Pedigree (Public Law 113-54); Prescription Drug Monitoring Programs; Prescription Drug Abuse - General issues related to Rx drug abuse (S. 348, S. 1277, H.R. 4069, H.R. 4709, S. 2862); Hydrocodone Rescheduling (H.R. 1285, S. 621); Dextromethorphan (S. 644); Drug Shortages - Gray Market (H.R. 1958); Counterfeit Drugs; Importation of Prescription Drugs (H.R. 3715, S. 2549)

Client expense: $361,413 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 H.R. 4709 - Ensuring Patient Access and Effective Drug Enforcement Act of 2014 S. 2529 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2014

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

Rx Pedigree (Public Law 113-54); Prescription Drug Monitoring Programs; Prescription Drug Abuse - General issues related to Rx drug abuse (S. 348, S. 1277, H.R. 4069, H.R. 4709, S. 2862); Hydrocodone Rescheduling (H.R. 1285, S. 621); Dextromethorphan (S. 644); Drug Shortages - Gray Market (H.R. 1958); Counterfeit Drugs; Importation of Prescription Drugs (H.R. 3715, S. 2549)

Client expense: $361,413 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Oversight of laboratory services, genetic information and testing. Patient Protection and Affordable Care Act (P.L. 111-148) implementation. H.R.4069, Ensuring Patient Access and Effective Drug Enforcement Act of 2013, policies regarding drugs of abuse testing.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Ensuring Patient Access and Effective Drug Enforcement Act (H.R. 4069/S. 2862); Average Sales Price calculation/prompt pay discount (H.R. 800); Tax (Last in, first out)

Client expense: Not reported · Firm income: Not reported

The Ensuring Patient Access and Effective Drug Enforcement Act (H.R. 4069/S. 2862); Average Sales Price calculation/prompt pay discount (H.R. 800); Tax (Last in, first out)

Client expense: Not reported · Firm income: Not reported

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 ***, no specific bills, drug safety

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum pageImportation of prescription drugs (H.R. 3715, S. 2549) Drug Shortages and Gray Market (H.R. 1958) Rx Pedigree (PL 113-54) Prescription Drug Monitoring Programs Counterfeit Drugs Prescription Drug Abuse - General issues related to Rx drug abuse (S. 348, S. 1277, H.R. 4069, H.R. 4709, S. 2862), Hydrocodone Rescheduling (H.R. 1285, S. 621), Dextromethorphan (S. 644)

Client expense: Not reported · Firm income: $80,000

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

H.R.4069, Ensuring Patient Access and Effective Drug Enforcement Act of 2013, Monitor drug enforcement related issues.

Client expense: Not reported · Firm income: $60,000

Government targets: SENATE

Issues concerning prescription drug abuse including H.R. 3392, The Medicare Part D Patient Safety & Drug Abuse Prevention Act; and H.R. 4069, The Ensuring Patient Access & Effective Drug Enforcement Act of 2014.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

All legislative and executive actions concerning healthcare reform, including provisions related to medication therapy management (MTM), pharmacy dispensing fees, drug safety, prescription drug diversion and abuse, drug shortages, supply chain, Medicare Sustainable Growth Rate, Medicaid reimbursement, and provider status S. 557 - Medication Therapy Management Empowerment Act of 2013 H.R. 1024 - Medication Therapy Management Empowerment Act of 2013 H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 S. 1277 - Combating Prescription Drug Abuse Act H.R. 4190 - Improved Patients' Access to Pharmacist Services

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to prescription drug abuse, drug supply chain safety. HR 4190-Medicare Patient Access to Pharmacy Services in Medically Underserved Communities HR 4069-Ensuring Patient Access and Effective Drug Enforcement Act of 2013

Client expense: $3,737,640 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

H.R.4069 - the "Ensuring Patient Access and Effective Drug Enforcement Act of 2013," all provisions related to changes to the registration process under the Controlled Substances Act and the establishment of the Combatting Prescription Drug Abuse Working Group.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4302, Protecting Access to Medicare Act of 2014 (P.L. 113-93); H.R. 2575, Save American Workers Act; H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013; H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement; Implementation issues related to the Patient Protection and Affordable Care Act (P.L. 111-148).

Client expense: $120,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, DEA regulation and related issuesH.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Secretary of Health and Human Services nomination Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

Client expense: $4,190,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H. R. 4069 and H.R. 4709: "Ensuring Patient Access and Effective Drug Enforcement Act of 2013" (All provisions, including Section 2, Registration Process Under Controlled Substances Act and Section 3, Combating Prescription Drug Abuse Working Group.)

Client expense: $410,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

H.R. 4709 & HR. 4069-Ensuring Patient Access and Effective Drug Enforcement Act"

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 ***, no specific bills, drug safety

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General monitoring of issues related to transporting pharmaceuticals H.R. 4069 Ensuring Patient Access and Effective Drug Enforcement Act of 2013

Client expense: $3,190,012 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Oversight of laboratory services, genetic information and testing. Patient Protection and Affordable Care Act (P.L. 111-148) implementation. H.R.4069, Ensuring Patient Access and Effective Drug Enforcement Act of 2013, policies regarding drugs of abuse testing.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum pageImportation of prescription drugs (H.R. 3715) Drug Shortages and Gray Market (H.R. 1958) Rx Pedigree (PL 113-54) Prescription Drug Monitoring Programs Counterfeit Drugs Prescription Drug Abuse - General issues related to Rx drug abuse (S. 348, S. 1277, H.R. 4069, H.R. 4709, S. 2437), Hydrocodone Rescheduling (H.R. 1285, S. 621), Dextromethorphan (S. 644)

Client expense: Not reported · Firm income: $80,000

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

Efforts to prevent prescription drug abuse. H.R. 4069: Ensuring Patient Access and Effective Drug Enforcement Act of 2013. H.R. 4709: Ensuring Patient Access and Effective Drug Enforcement Act of 2014.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Rx Pedigree (Public Law 113-54); Prescription Drug Monitoring Programs; Prescription Drug Abuse - General issues related to Rx drug abuse, (S. 348, S. 1277, H.R. 4069, H.R. 4709), Hydrocodone Rescheduling (H.R. 1285, S. 621); Dextromethorphan (S. 644); Drug shortages - Gray Market (H.R. 1958); Counterfeit Drugs; Importation of Prescription Drugs (H.R. 3715)

Client expense: $233,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 H.R. 4709 - Ensuring Patient Access and Effective Drug Enforcement Act of 2014 S. 2529 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2014

Client expense: $640,000 · 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

H.R.4069, Ensuring Patient Access and Effective Drug Enforcement Act of 2013, Drug enforcement related issues.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

All legislative and executive actions concerning healthcare reform, including provisions related to medication therapy management (MTM), pharmacy dispensing fees, drug safety, prescription drug diversion and abuse, drug shortages, supply chain, Medicare Sustainable Growth Rate, Medicaid reimbursement, and provider statusS. 557 - Medication Therapy Management Empowerment Act of 2013 H.R. 1024 - Medication Therapy Management Empowerment Act of 2013 H.R. 4069 - Ensuring Patient Access and Effective Drug Enforcement Act of 2013 S. 1277 - Combating Prescription Drug Abuse Act H.R. 4190 - Improved Patients' Access to Pharmacist Services

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE

Issues related to prescription drug abuse, drug supply chain safety. HR 3204-Drug Quality and Security Act HR 4069-Ensuring Patient Access and Effective Drug Enforcement Act of 2013

Client expense: $2,950,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

H.R.4069 - the "Ensuring Patient Access and Effective Drug Enforcement Act of 2013," all provisions related to changes to the registration process under the Controlled Substances Act and the establishment of the Combatting Prescription Drug Abuse Working Group.

Client expense: $610,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act of 2013: Provisions related to antibiotics and drug approval H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement Act of 2013: Provisions related to the Controlled Substances Act, DEA regulation and related issuesS. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Quality, Security, and Accountability Act: Provisions related to pharmaceutical compounding S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

Client expense: $4,680,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office