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. 244: Consolidated Appropriations Act, 2017
H.R. __: Making appropriations for Agriculture, Rural Development, Food and Drug Administration and Related Agencies programs for the fiscal year ending September 30, 2018, and for other purposes
Budget of the United States Government, Fiscal Year 2018 - A New Foundation for American Greatness - Provisions related to non-defense program funding including FDA and NIH and repeal of the Independent Payment Advisory Board (IPAB)

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), Food & Drug Administration (FDA), White House Office, 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 CPT

16. Specific lobbying issues

S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 1390: STRONGER Patents Act - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms
Biopharmaceutical innovation and patent policy issues
Patent litigation reform issues and issues related to post-grant proceedings 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), White House Office

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

Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft)
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. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness
S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals
S. 456: RACE for Children Act - Provisions related to pediatric studies
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. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program
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
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. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls
H.R. 1231: RACE for Children Act - Provisions related to pediatric studies
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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs
H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing
H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems
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. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems
H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs
H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act to give DEA greater authority to schedule certain synthetic drugs
H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding
Prescription Drug User Fee Act (PDUFA) reauthorization and related issues
Biologics User Fee Act (BsUFA) reauthorization
Biopharmaceutical innovation policy issues
Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA)
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
Expanded access policy issues
Expedited drug approval 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
Vaccines policy issues
Limited distribution systems in the pharmaceutical supply chain policy issues
FDA modernization policy issues
340B drug discount program policy issues
Interim Final Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AA89 (82 Fed. Reg. 14332 (March 20, 2017))
Orphan Drug Act 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 and FDA policy
Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues
Biologics Price Competition and Innovation Act (BPCIA) implementation issues
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Drug compounding policy issues including federal oversight of compounded drugs
Clinical trial policy issues
Cancer drug vial size policy issues
Nomination and Confirmation of Scott Gottlieb as FDA Commissioner

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), Food & Drug Administration (FDA), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of the Vice President of the United States, Treasury - Dept of, White House Office, Government Accountability Office (GAO)

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

Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft)
S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB)
S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB
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 cost of prescription drugs
H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB
H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies
H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal
S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal
S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal
Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care
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
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Prescription drug abuse 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), Health & Human Services - Dept of (HHS), Centers For Medicare and Medicaid Services (CMS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of the Vice President of the United States, Food & Drug Administration (FDA), White House Office, Treasury - Dept of

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
Canada intellectual property and market access 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), Commerce - Dept of (DOC), U.S. Trade Representative (USTR), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), White House Office, 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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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