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

S. 2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry
S. 3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry
H.R. 5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry
H.R. 5926: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry
Senate and House budget process
Continuing Resolution
Budget Reconciliation

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

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. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement
S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements
S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion
S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO
S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity
S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue
H.R. 9: Innovation Act - Provisions related to patent litigation reform
Provisions related to exclusivity
Patent litigation reform issues and issues related to post-grant proceedings at the PTO
Patent settlement policy issues
Biopharmaceutical innovation and patent policy issues
Bayh-Dole Act march-in rights policy issues

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, 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

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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 HCR

16. Specific lobbying issues

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation
S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population
S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding
S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees
S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation
S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program
S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues
S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments
S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH
S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness
S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs
S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency
H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency
H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program
H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products
H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse
H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing
H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness
H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues
H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments
H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications
H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models
H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies
H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency
H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs
Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs
The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments
Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development
Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs
Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues
Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures
Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy
Proposed HRSA 340B program mega-guidance - Provisions related to 340B program
Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges
340B Drug Discount Program policy issues
General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals
Prescription Drug User Fee Act (PDUFA) reauthorization
Biosimilar User Fee Act (BsUFA) reauthorization
Biologics Price Competition and Innovation Act (BPCIA) implementation issues
Biopharmaceutical and medical innovation policy issues
Drug development ecosystem policy issues
Drug cost and pricing policy issues
Expedited drug approval policy issues
Compassionate use policy issues
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Transparency policy issues
NIH Funding policy issues
Precision Medicine Initiative
Biomarker policy issues
Policy issues related to prescription drug abuse and secure disposal
Drug compounding policy issues
Prescription drug importation policy issues
Cancer Moonshot
Prescription drug take back policy issues
Clinical trial policy issues
Pediatric cancer policy issues
Cancer drug vial size policy issues
House Republican Health Proposal (A Better Way)
Expanded access policy issues

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, 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 MMM

16. Specific lobbying issues

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model
Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule (CMS-1654-P) - Expansion of Medicare Diabetes Prevention Program Model
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program
S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal
S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program
S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D
S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures
H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry
H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal
H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates
H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures
H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model
Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation
Medicare Part B Average Sales Price (ASP) policy issues
Medicare Part D rebates policy issues
Drug cost and pricing policy issues
Transparency policy issues
Alternative payment models policy issues
Value-based arrangements policy issues
Coding and reimbursement policy issues including for biologics
Prescription drug abuse policy issues
Center for Medicare and Medicaid Innovation (CMMI) transparency and other policy issues
MedPAC June Report - Part B and D policy issues
Medicaid rebates/reformulations policy issues
Non-interference policy issues

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)

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

Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections
Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues
Biopharmaceutical innovation policy issues
China intellectual property and market access policy issues
India innovation, intellectual property, and market access policy issues
International market access, intellectual property, and regulatory policy issues
Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues
Canada intellectual property and market access policy issues
Japan pricing, market access and reimbursement policy issues
Turkey market access and reimbursement policy issues
Indonesia intellectual property policy issues
Colombia intellectual property policy issues
UN High-Level Panel on Access to Medicines - 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, U.S. Trade Representative (USTR), Commerce - Dept of (DOC), State - Dept of (DOS)

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