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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1625 Eye Street NW |
Address2 | Suite 600 |
City | WASHINGTON |
State | DC |
Zip Code | 20006 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 29403-12
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6. House ID# 312860000
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TYPE OF REPORT | 8. Year | 2018 |
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: David Spangler |
Date | 10/12/2018 11:30:28 AM |
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
Pseudoephedrine
Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number).
Oral Contraceptives
H.R. 421/S. 93 - Allowing Greater Access to Safe and Effective Contraception Act of 2017. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections.
Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch
Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.
S. 2825/H.R. 6378 -- Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018. To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA)
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 |
John |
Gay |
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Marc |
Schloss |
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Taylor |
Holgate |
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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 ALC
16. Specific lobbying issues
Dextromethorphan
H.R. 1271, the "DXM Abuse Prevention Act" (DAP) - legislation that would ban the sale of over-the-counter cough and cold medications containing the active ingredient dextromethorphan (DXM) to minors under the age of 18. Additionally, would ban the sale of bulk, unfinished DXM to entities not registered with the U.S. Food and Drug Administration; all sections.
Tableting and Encapsulating Machine Regulation Act of 2018, no bill number. Gives the Drug Enforcement Agency additional authority to regulate tableting and encapsulating manufacturing machines.
FDA Packaging and Disposal, no bill number. Directs FDA to work with manufacturers to establish programs for efficient return or destruction of unused Schedule II drugs, with an emphasis on opioids. These methods could include mail-back pouches to secure facilities for incineration, or methods to immediately inactivate/render unattractive unused drugs.
H.R. 5628/S. 2645 Access to Increased Drug Disposal Act of 2018. Establishes a demonstration program under which the Drug Enforcement Administration provides grants and technical assistance to certain States to enable those States to increase participation in drug take-back programs.
H.R.6 - SUPPORT for Patients and Communities Act. This bill makes several changes to state Medicaid programs to address opioid and substance use disorders. The bill also alters Medicare requirements to address opioid use. Additionally, the bill temporarily eliminates the enhanced federal matching rate for Medicaid expenditures regarding specified medical services provided by certain managed care organizations.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA)
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 |
John |
Gay |
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Marc |
Schloss |
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Taylor |
Holgate |
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David |
Spangler |
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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 TAX
16. Specific lobbying issues
Flexible spending arrangements (FSA) and health savings accounts (HSA)
Graham-Cassidy Bill, no bill number. Graham-Cassidy contained a provision (section 108) to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescriptions prior to using an FSA or HSA to purchase OTC medicine.
Better Care Reconciliation Act (H.R. 1628). BCRA contained a provision(section 209)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines.
American Healthcare Act (AHCA), no bill number. AHCA contained a provision(section 208)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines.
H.R. 394/S. 85 - Restoring Access to Medication Act of 2017. Repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications; all sections.
H.R. 1175/S.403 - Health Savings Act of 2017 - Codifies OTC medications as qualified medical expenses; Section 301
H.R.4618 - To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication. Temporarily repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications.
H.R.1625 - Consolidated Appropriations Act, 2018. Omnibus appropriations package.
H.R. 6199 -- To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. Repeals provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that limit payments for medications from health savings accounts, medical savings accounts, health flexible spending arrangements, and health reimbursement arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs). The bill also allows the accounts to be used for menstrual care products.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Treasury - Dept of
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 |
John |
Gay |
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Marc |
Schloss |
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Taylor |
Holgate |
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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 FOO
16. Specific lobbying issues
Dietary Supplements
SNAP Vitamin and Mineral Improvement Act (H.R. 3841). This bill would expand the SNAP program to include dietary supplements.
Food and Drug Administration (FDA) draft "Guidance for Industry: New Dietary Ingredient Notifications and Related Issues."
Possible reintroduction of "Free Speech About Science Act of 2011" (H.R. 1364, 112th Congress) - would establish conditions under which a food or dietary supplement label may characterize the relationship of a nutrient in the food or supplement to a disease or health-related claim; all sections.
WIC Improvement Act, H.R. 3529. This legislation would allow for multivitamin dietary supplements to be included in WIC food packages.
Farm Bill H.R. 2/S. 3042 -- Provisions making multivitamins eligible for purchase using SNAP benefits.
Accurate Labels Act S.3019/H.R. 6022 -- standardizing compliance for California's prop 65 and similar labeling requirements.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA)
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 |
John |
Gay |
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Marc |
Schloss |
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Taylor |
Holgate |
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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 MAN
16. Specific lobbying issues
OTC Drug Review Monograph
H.R 5333/S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act. Legislation to update and modernize the Over-the-Counter Drug Review Monograph system, which regulates the manufacture, labeling, and marketing of specific over-the-counter (OTC) drugs.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA)
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 |
John |
Gay |
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Marc |
Schloss |
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David |
Spangler |
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Taylor |
Holgate |
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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
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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 |