GENENTECH, INC for GENENTECH INC

Trade (domestic/foreign) TRD

Issues relating to U.S. trade policy and TransPacific Partnership.

Contacted: Food & Drug Administration (FDA); SENATE; Centers For Disease Control & Prevention (CDC); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES

Taxation/Internal Revenue Code TAX

Issues related to several tax issues and tax reform. Issues relating to corporate tax reform including taxation of foreign-owned US corporations. Issues relating to proposed regulations under Section 385 of the Internal Revenue Code.

Contacted: Executive Office of the President (EOP); U.S. Trade Representative (USTR); SENATE; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Centers For Disease Control & Prevention (CDC)

Copyright/Patent/Trademark CPT

Intellectual Property and Process Patent Issues. General IP Issues; Patent Litigation Reform; Transpacific Partnership Agreement.

Contacted: Centers For Disease Control & Prevention (CDC); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); SENATE; U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS)

Health Issues HCR

H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Sccoubtability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA".

Contacted: Centers For Disease Control & Prevention (CDC); Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Executive Office of the President (EOP); Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 6 (114th)

Medicare/Medicaid MMM

Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. 21st Century Cures initiative. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars.

Contacted: Executive Office of the President (EOP); SENATE; HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Budget/Appropriations BUD

S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.

Contacted: SENATE; U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Centers For Disease Control & Prevention (CDC); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Executive Office of the President (EOP)

Bills named: S. 2956 (114th), H.R. 5054 (114th), S. 3040 (114th)

Pharmacy PHA

Implementation of the Pharmaceutical, Quality, Safety & Accountability Act (P.L. 113-54). 340B drug discount program.

Contacted: Centers For Disease Control & Prevention (CDC); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); Food & Drug Administration (FDA); U.S. Trade Representative (USTR); SENATE

Homeland Security HOM

S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.

Contacted: Executive Office of the President (EOP); U.S. Trade Representative (USTR); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE; Centers For Disease Control & Prevention (CDC); Health & Human Services, Dept of (HHS)

Bills named: S. 1027 (114th), S. 177 (114th), S. 961 (114th), S. 456 (114th), H.R. 1770 (114th), H.R. 2205 (114th)