Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

H.R. 5515: National Defense Authorization Act for Fiscal Year 2019 - Provisions related to prescription drugs in TRICARE
H.R. 5961: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs
H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 - Provisions related to prescription drugs, defense research, and opioids
S. 2976: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs
S. 2987: John S. McCain National Defense Authorization Act for Fiscal Year 2019 - Provisions related to prescription drugs in TRICARE
S. 3158: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019
S. 3159: Department of Defense Appropriations Act, 2019 - Provisions related to prescription drugs, defense medical research, and opioids

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP), Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CPT

16. Specific lobbying issues

H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms
H.R. 5887: BIG Data for IP Act - Provisions related to fee-setting authority
H.R. 6758: SUCCESS Act - Provisions related to fee authority and study
S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings
S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms
S. 3416: USPTO FEES Act - Provisions related to fee-setting authority
Biopharmaceutical innovation and patent policy issues
Patent litigation reform issues and issues related to post-grant proceeding at the PTO
Bayh-Dole march-in rights policy issues

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP), Patent & Trademark Office (PTO)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes
H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report
H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals
H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms
H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing
H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties
H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems
H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training
H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances
H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records
H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access
H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education
H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information
H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program
H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements
H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication
H.R. 5009: Jessies Law - Provisions related to patient information
H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal
H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program
H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery
H.R. 5228: SCREEN Act - Provisions related to drug recall authority
H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act
H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants
H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding
H.R. 5582: Abuse Deterrent Access Act of 2018
H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program
H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs
H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation
H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States
H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018
H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval
H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements
H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing
H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records
S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing
S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing
S. 1327: SITSA Act - Provisions related to controlled substances
S. 2157: Drug-Price Transparency in Communications Act
S. 2312: HELP Act - Provisions related to 340B program
S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program
S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing
S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees
S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety
S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids
S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018
S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling
Drug cost and pricing policy issues
Transparency policy issues
Drug importation and counterfeiting policy issues
Prescription drug take back and secure disposal policy issues
Policy issues related to prescription drug abuse and opioids
Expanded access policy issues
Generic drug approval process policy issues
High deductible health plans/HSA policy issues
Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors
Risk Evaluation and Mitigation Strategy (REMS) policy issues
FDA modernization policy issues
PDUFA implementation policy issues
340B drug discount program policy issues
Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Drug compounding policy issues including federal oversight of compounded drugs
Cancer drug vial size policy issues
TRICARE pharmacy pilot program
Drug shortages policy issues
Reauthorization of the Pandemic and All-Hazards Preparedness Act
Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP), Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies
H.R. 3192: CHIP Mental Health Parity Act
H.R. 3635: Local Coverage Determination Clarification Act of 2018
H.R. 4005: Medicaid Reentry Act
H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs
H.R. 5590: Opioid Addiction Action Plan Act
H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act
H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries.
H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act
H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act
H.R. 5801: Medicaid PARTNERSHIP Act
H.R. 5808: Medicaid Pharmaceutical Home Act of 2018
H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act
H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018
H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs
H.R. __: To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission with access to certain drug rebate information
S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D
S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers
S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care
S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs
S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions
S. 3000: Patient Advocacy Transparency Act - Social Security Act amendments
Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues
Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues
Part D policy issues including non-interference and rebates policy issues
Part B reform including MedPAC recommendations and other policy issues and local coverage decisions
Drug cost and pricing policy issues
Transparency policy issues
Alternative payment models policy issues
Value-based purchasing arrangements policy issues
Anti-Kickback Statute policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Prescription drug abuse policy issues
Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018
Proposed Rule; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)
Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018)
Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP), Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS), Centers For Medicare and Medicaid Services (CMS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TRD

16. Specific lobbying issues

Trade Agreements including NAFTA and related policy issues
Biopharmaceutical innovation policy issues
International intellectual property and market access policy issues
Pricing and reimbursement policy issues

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address: http://www.phrma.org/about/members

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization