4th Quarter - Report — CALIFORNIA LIFE SCIENCES for CALIFORNIA LIFE SCIENCES (2020)

Firm

CALIFORNIA LIFE SCIENCES

Client

CALIFORNIA LIFE SCIENCES

Income

—

Expenses

$143,000

Expense method

A: Lobbying Disclosure Act definitions

What was lobbied

10 issue areas, each in the filer's own words, with who lobbied on it and where.

Trade (domestic/foreign) TRD

Oppose proposals to reduce data exclusivity.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: SENATE; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS)

Copyright/Patent/Trademark CPT

Address concerns with provisions of patent litigation reform, including inter partes review. Support STRONGER Patents Act. Oppose "march-in" rights and "compulsory licensing" proposals. Support transferable exclusivity extensions to incentivize novel antibiotic Research and Development.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: SENATE; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Securities & Exchange Commission (SEC)

Budget/Appropriations BUD

Labor/HHS/Ed Appropriations: NIH, antimicrobial resistance, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation; Coronavirus funding and response FDA Appropriations; PTO Appropriations.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); SENATE; Securities & Exchange Commission (SEC); Food & Drug Administration (FDA)

Disaster Planning/Emergencies DIS

Support exemptions from California's COVID-19 stay-at-home order for the life sciences community

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; SENATE

Defense DEF

Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Securities & Exchange Commission (SEC)

Taxation/Internal Revenue Code TAX

Support R&D and NOL tax incentives

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); SENATE; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS)

Health Issues HCR

Support FDA user fee programs and review process consistency and predictability. Support policy improvements to address antimicrobial resistance. Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices. Support improvements to the Strategic National Stockpile for pandemic testing preparedness. Support public education campaign on pandemic preparedness. Support reauthorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program. Oppose drug importation proposals.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: SENATE; Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Securities & Exchange Commission (SEC); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS)

Small Business SMB

Support changes to SBA's "affiliation rule." Support changes to Main Street Lending Program's eligibility criteria. Oppose changes to SEC 13(F) Reporting Threshold. Support Emerging Growth Companies (EGCs) Extension due to COVID-19.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Securities & Exchange Commission (SEC); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); SENATE

Medicare/Medicaid MMM

Address concerns with changes to Medicare Part B and Part D programs, and Hospital Outpatient Prospective Payment System. Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule, and legislation. Oppose drug importation proposals. Support temporary home administration of Medicare Part B infused and injectable medicines during the COVID-19 public health emergency. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule regarding cost-sharing assistance. Support separate reimbursement structure for novel antibiotics to incentivize R&D. Support Medicare coverage of remote patient monitoring services. Oppose prior authorization requirements in Medicare Advantage. Support expanded access to telehealth. Support value-based purchasing provision, but opposed line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE; Securities & Exchange Commission (SEC); Health & Human Services, Dept of (HHS)

Medical/Disease Research/Clinical Labs MED

Support NIH research funding. Support implementation of 21st Century Cures Act.

Lobbyist	Covered position, as disclosed
MOLLY FISHMAN	—
JULIA MCNERNEY New	—
DANIELLE MITCHELL New	—

Contacted: Health & Human Services, Dept of (HHS); Securities & Exchange Commission (SEC); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; SENATE; Food & Drug Administration (FDA)

Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.