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

FY2017 Appropriations bills including Military Construction, Veterans Affairs, and Related Agencies; Labor, Health and Human Services, Education, and Related Agencies; and Agriculture, Rural Development, Food and Drug Administration, and Related Agencies - Issues related to the biopharmaceutical industry
Presidents FY2017 Budget - Issues related to the biopharmaceutical industry
Senate and House budget process

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

​

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. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity
S. 1890: Defend Trade Secrets Act of 2016 - Provisions related to improving trade secret protection
S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements
S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to leveraging of data
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 and post-grant proceedings at the PTO
H.R. 3326: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection
H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC)
Issues related to abuse deterrent exclusivity incentives
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

​

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 NIH funding
S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees
S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling
S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2016 - Provisions related to registration under the Controlled Substances Act (CSA)
S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids
S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research
S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases
S. 1128: Preserving Access to Orphan Drugs Act of 2013 - Provisions related to orphan drug tax (113th Congress)
S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids
S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development
S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation
S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products
S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases
S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research.
S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation
S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment
S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents
S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals
S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development
S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers
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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA
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
H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency
H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union
H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program
H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research
H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs
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. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs
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 - 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. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research
H.R. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act
H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances
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
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
ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances
Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website
Drug Supply Chain Security Act policy issues
Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA)
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
Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] Provisions related to 340B program
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 issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges
Physician Payment Sunshine Act implementation issues, such as Open Payments System issues
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) negotiation and reauthorization
Biologics Price Competition and Innovation Act (BPCIA) implementation issues
Generic Drug User Fee Act (GDUFA) policy 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
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
Antibiotics development policy issues
Drug compounding policy issues
Nomination of Robert Califf to FDA Commissioner
Prescription drug importation policy issues
Cancer Moonshot

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Vice President of the U.S., 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 MMM

16. Specific lobbying issues

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 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
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. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage
S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program
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. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology
S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program
S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option
S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program
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
S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates
S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing
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. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program
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. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates
Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid
Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P)
Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P)
Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform
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
Medication adherence policy issues
Alternative payment models policy issues
Value-based arrangements policy issues
Coding and reimbursement policy issues including for biologics
Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues
Chronic Care Working Group - Medicare policy affecting drugs

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), Medicare Payment Advisory Commission (MedPAC)

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 and intellectual property 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
Colombia intellectual property policy issues
Japan market access and reimbursement policy issues
Turkey market access and reimbursement 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, Commerce - Dept of (DOC), U.S. Trade Representative (USTR), 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

​

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/member-companies

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