CALIFORNIA LIFE SCIENCES for CALIFORNIA LIFE SCIENCES

Trade (domestic/foreign) TRD

Oppose proposals to reduce data exclusivity.

Contacted: Health & Human Services, Dept of (HHS); SENATE; Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH)

Defense DEF

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

Contacted: Food & Drug Administration (FDA); SENATE; Natl Institutes of Health (NIH); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS)

Taxation/Internal Revenue Code TAX

Support Research & Development and NOL tax incentives. Orphan Drug Tax Credits

Contacted: Natl Institutes of Health (NIH); SENATE; HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS)

Medical/Disease Research/Clinical Labs MED

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

Contacted: HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); SENATE; Centers For Medicare and Medicaid Services (CMS); Natl Institutes of Health (NIH)

Disaster Planning/Emergencies DIS

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

Contacted: Health & Human Services, Dept of (HHS); SENATE; Food & Drug Administration (FDA); Natl Institutes of Health (NIH); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES

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 & Development.

Contacted: HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); SENATE; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Health Issues HCR

Support FDA user fee programs and review process consistency and predictability. Support FDA modernization practices. Support FDA modernization efforts and vaccine awareness. 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. Oppose drug pricing proposals that allow Medicare to directly negotiate prices.

Contacted: Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); SENATE; HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); Food & Drug Administration (FDA)

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, and H.R. 3. 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, final rule implementation, 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 re cost-sharing assistance. Support separate reimbursement structure for novel antibiotics to incentivize Research & Development. 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 oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.

Contacted: SENATE; Centers For Medicare and Medicaid Services (CMS); Natl Institutes of Health (NIH); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Bills named: H.R. 3 (117th)

Budget/Appropriations BUD

Labor/HHS/Ed Appropriations: Drug Pricing, FDA, NIH, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation; Coronavirus funding and response FDA Appropriations; PTO Appropriations. Drug Pricing proposals, Orphan Drug Tax Credit.

Contacted: Natl Institutes of Health (NIH); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS)