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. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs
H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs
H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs
H.R. 2500: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs
H.R. 2740: Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs
H.R. 3055: Making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes - FDA provisions related to prescription drugs
H.R. 3164: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs
H. Res. 436: Providing for further consideration of the bill (H.R. 2740) making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes
H. Res. 4455: Providing for consideration of the bill (H.R. 3055) making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes; relating to consideration of the bill (H.R. 2740) making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes; and providing for proceedings during the period from June 28, 2019, through July 8, 2019
S. 1215: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs
S. 1790: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs
Presidents FY 2020 Budget Request - Medicare and Medicaid provisions and other 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), 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. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights
H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity
H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues
H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms
H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing
H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing
H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements
H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements
H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug patent listings
H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings
H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions
H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions
H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions
H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents
S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights
S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms
S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing
S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing
S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures
S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions
S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents
S. 1224: Stop STALLING Act - Provisions related to citizen petitions
S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents
S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents
S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity
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, 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. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act
H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation
H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing
H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency
H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation
H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals
H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing
H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing
H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products
H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration
H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing
H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples
H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs
H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency
H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples
H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers
H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency
H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers
H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding
H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings
H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs
H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing
H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers
H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising
H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity
H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency
H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency
H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals
S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation
S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising
S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing
S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals
S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes
S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs
S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency
S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates
S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals
S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process
S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing
S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing
S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration
S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products
S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers
S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates
S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency
S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising
S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers
S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency
Transparency policy issues
Drug cost and pricing 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
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), Health & Human Services - Dept of (HHS), 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

H.R. 107: 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 - Provisions related to Medicaid drug rebates
H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation
H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing
H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation
H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification
H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates
H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers
H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing
H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation
H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights
H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting
H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment
H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification
H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation
H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation
H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation
H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing
H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans
H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans
H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates
S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation
S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation
S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification
S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing
S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing
S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation
S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers
S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates
S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates
S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs
S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting
S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation
S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation
S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates
S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency
S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues
S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling
S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured
S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements
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
ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM)
Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P)
Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-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), 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 TRD

16. Specific lobbying issues

H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues
Trade Agreements including NAFTA, USMCA and related policy issues
US-China trade policy issues including regulatory data protection for biologics
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), U.S. Trade Representative (USTR)

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

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
No Yes