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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1455 Pennsylvania Ave., NW |
Address2 | Suite 500 |
City | Washington |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
City | Cambridge |
State | MA |
Zip Code | 02141 |
Country | USA |
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5. Senate ID# 16054-12
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6. House ID# 302570000
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TYPE OF REPORT | 8. Year | 2016 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
10. Check if this is a Termination Report | Termination Date |
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11. No Lobbying Issue Activity |
INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
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12. Lobbying | 13. Organizations | ||||||||
INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
Signature | Digitally Signed By: Sara Froelich |
Date | 7/20/2016 11:44:41 PM |
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
Part D drug coverage and patient access issues and policy
ESRD bundling and drug reimbursement issues
HCPCS coding and reimbursement decisions
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152)
Least costly alternative (LCA) policy
Changes re: Medicare Part B and Average Sales Price
Medicare secondary payor for ESRD services
Extension of rebates on Medicare Part D drugs
Performance measures for bone and mineral metabolism for ESRD program
Implementation of American Taxpayer Relief Act of 2012
H.R. 1416, Cancer Patient Protection Act of 2015
21st Century Cures/Innovation initiatives, including H.R. 6, 21st Century Cures Act
S. 506, To amend Part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes
H.R. 696, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes
Medicaid drug rebate, drug coverage and patient access to therapies issues and policy
S. 31, Medicare Prescription Drug Price Negotiation Act of 2015
H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015
S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015
S. 648, Medicare Formulary Improvement Act of 2015
H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015
H.R.2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015
H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS)
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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 PHA
16. Specific lobbying issues
Food and Drug Administration Safety and Innovation Act (FDASIA) implementation
Issues and policies related to biosimilars exclusivity period
Biosimilars FDA guidance
Implementation of Drug Quality and Security Act
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152)
Issues and policies related to FDA oversight and management
Issues and policies related to expanded access programs
Issues and policies related to patient involvement with FDA decision making
S.2912, Trickett Wendler Right to Try Act of 2016
H.R. 3012, Right to Try Act of 2015
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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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 TAX
16. Specific lobbying issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152)
Excise tax for drugs and biologics
Issues and policies related to Orphan Drug Tax Credit
Implementation of American Taxpayer Relief Act of 2012
Issues and policies related to tax reform
H.R. 880, American Research and Competitiveness Act of 2015
S. 537, Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2015(COMPETE Act)
Corporate tax inversions issues
Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015
H.R. 3618 and S. 1906, Orphan Drug Fairness Act
Protecting Americans From Tax Hikes Act of 2015 (PATH)
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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152)
340B issues and legislative reform proposals
Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015
Health technology assessment of orphan drugs
Sequestration of FDA user fees
H.R. 1376, Patient Choice Act of 2015
H.R. 790, Compassionate Freedom of Choice Act of 2015
H.R. 1600, Patients' Access to Treatments Act of 2015
21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act
H.R. 909, Andrea Sloan CURE Act
S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144)
Regulation of innovative biological products for neurodegenerative diseases
Issues and policies related to implementation of Orphan Drug Act and orphan drug development
S. 320, Medical Innovation Act
H.R. 744, Medical Innovation Act
S. 2615, Increasing Competition in Pharmaceuticals Act
H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015
S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015
H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015
H.R. 1531 and S.1878, Advancing Hope Act of 2015
Implementation of newborn screening programs
Issues and policies related to biosimilars exclusivity period
Issues and policies related to biosimilars FDA guidance
Issues and policies related to FDA oversight and management
Issues and policies related to expanded access programs
Issues and policies related to patient involvement with FDA decision making
S. 289 and H.R. 2104, American Cures Act
Legislation pertaining to FDA priority review vouchers, generally
Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015
H.R. 3618 and S. 1906, Orphan Drug Fairness Act
Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015
Drug shortage issues
Issues related to health care transparency
S. 2055, Medical Countermeasure Innovation Act of 2016
H.R. 3299, Strengthening Public Health Emergency Response Act
S. 2700, FDA and NIH Workforce Authorities Modernization Act
S. 2713, Advancing Precision Medicine Act of 2016
S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act
S. 2742, Promoting Biomedical Research and Public Health for Patients Act
S. 3239, H.R. 5858, The RACE for Children Act
S. 2689, The REGROW Act
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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Funding for FDA and NIH
Issues and policies related to FY 2017 Appropriations and all applicable amendments
H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015
H.R.3762, To provide for reconciliation pursuant to section 2002 of the concurrent resolution on the budget for FY 2016
Issues and policies related to H.Con.Res. 125, House FY 2017 budget resolution and all applicable amendments
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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Patent settlement legislation, including HR 9, Innovation Act of 2015, S. 632, STRONG Patents Act of 2015, and S.1137, PATENT Act
S.2019, Preserve Access to Affordable Generics Act
S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016
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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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 Promotion Authority legislation and other trade issues, including the Trans-Pacific Partnership (TPP)
Protection and promotion of 12 years exclusivity for biosimilars
Protection and Promotion of Orphan Drug Act market exclusivity
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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
Information Update Page - Complete ONLY where registration information has changed.
20. Client new address
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21. Client new principal place of business (if different than line 20)
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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
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ISSUE UPDATE
24. General lobbying issue that no longer pertains
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AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
Name | Address |
Principal Place of Business (city and state or country) |
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
1 | 2 | 3 |
FOREIGN ENTITIES
27. Add the following foreign entities:
Name | Address |
Principal place of business (city and state or country) |
Amount of contribution for lobbying activities | Ownership percentage in client | ||||||||||
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28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization
1 | 3 | 5 |
2 | 4 | 6 |