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 relatd 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 Appropriations Act, 2019 - Provisions related to prescription drugs, defense medical research, and opioids
H.R. __: Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes - Provisions related to prescription drugs
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. 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), Health & Human Services - Dept of (HHS), Centers For Medicare and Medicaid Services (CMS), Office of Management & Budget (OMB)

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
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 inter partes review process
S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms
S. 2601: BIG Data for IP 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), U.S. Trade Representative (USTR), Natl Institute of Standards & Technology (NIST)

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. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness
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. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications
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. 3528: Every Prescription Conveyed Securely Act - e-Prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances
H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing
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 2017 - Provisions related to substance data collection
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 sharing
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 student loan repayment to substance use disorder (SUD) providers
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. 5151: To amend the Public Health Service Act to reauthorize a grant program improving treatment for pregnant and postpartum women
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. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness
H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery
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. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding
H.R. 5477: Rural DOCS Act - To provide for a demonstration project to increase substance use provider capacity under the Medicaid program
H.R. 5580: STOP Fentanyl Deaths Act of 2018 - To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl
H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program
H.R. 5676: Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 - To authorize the suspension of payments by Medicare prescription drug plans and MA-PD plans pending investigations of credible allegations of fraud by pharmacies
H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs
H.R. 5711: Improving Access to Mental Health Services Act - To allow National Health Service Corps members to provide obligated service as behavioral and mental health professionals at schools, other community-based settings, or patient homes
H.R. 5723: Expanding Oversight of Opioid Prescribing and Payment Act of 2018 - To require the Medicare Payment Advisory Commission to report on opioid payment, adverse incentives, and data under the Medicare program
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. 5774: Combating Opioid Abuse for Care in Hospitals Act of 2018 - Provisions related to opioids
H.R. 5775: Providing Reliable Options for Patients and Educational Resources Act of 2018 - To require Medicare Advantage plans and part D prescription drug plans to include information on the risks associated with opioids, coverage of certain nonopioid treatments used to treat pain, and on the safe disposal of prescription drugs
H.R. 5796: Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018 - To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids
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. 6071: SERV Communities Act - Provisions related to transparency in the 340B program
H.R. 6110: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018'
H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste
S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness
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. 2312: HELP Act - Provisions related to 340B program
S. 2406: ACE Research Act - Research initiatives of the NIH
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 - Provisions related to drug pricing
S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding
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. 2842: Opioid Addiction Recovery Fraud Prevention Act of 2018 - Provisions related to opioid treatment programs or products
S. __: Drug Accepted Use Labeling Act of 2018 - Provisions related to 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
Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors
Risk Evaluation and Mitigation Strategy (REMS) policy issues
Limited distribution systems in the pharmaceutical supply chain policy issues
FDA modernization policy issues
340B drug discount program policy issues
21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency
Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy
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
Opioids 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, Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Office of Management & Budget (OMB), Federal Trade Commission (FTC), Office of the Vice President of the United States

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. 4005: Medicaid Reentry Act
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. 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. 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
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
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)

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

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

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 TRD

16. Specific lobbying issues

Trade Agreements 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, Commerce - Dept of (DOC), U.S. Trade Representative (USTR), 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

​

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