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Professionnels
Image: Sandra Gonzalez

Sandra Gonzalez

Associate, Litigation Department
New York
200 Park Avenue
New York, NY
10166
United States

Fax: 1(212) 319-4090

Overview

Sandra González is an associate in the Litigation practice of Paul Hastings and is based in the firm's New York office. Her practice focuses on representing life sciences companies, of all sizes and throughout the product lifecycle, in connection with internal and government investigations and advising clients on day-to-day U.S. and OUS compliance matters.

Ms. González has particular experience counseling life sciences companies on a variety of matters, including: U.S. fraud and abuse laws; promotional activities; interactions with healthcare professionals ("HCPs"), patients, and patient advocacy organizations ("PAO"); industry standards and best practices; and anti-corruption and anti-bribery ("ABAC") laws, including the Foreign Corrupt Practices Act ("FCPA") and the UK Bribery Act.

Education

  • Rutgers University School of Law, Newark, NJ, J.D., 2011

  • State University of New York-New Paltz, New Paltz, NY, 2007


Foreign Language Capabilities

  •  Ms. González is a native Spanish speaker.

Speaking Engagements

  • Program Faculty, Seton Hall Law School, U.S. Healthcare Compliance Certification Program

  • Co-Author, Considerations in View of the Patient Journey: Compliance in the Rare Disease Space (Part 1), Policy & Medicine Compliance Update (June 2020)

  • Co-author, 

    Paul Hastings (April 22, 2020)

  • Co-Author, Bracing for a Life Sciences Enforcement Zeitgeist, Law360 (November 6, 2017)

  • Co-Author, Against the Backdrop of a "National Emergency," Are Opioid Manufacturers Ready for the Enforcement Spotlight?, Bloomberg Law, Pharmaceutical Law Industry Report (August 25, 2017)

  • Presenter, Uncharted Compliance Waters-Ex-U.S. Transparency Challenges, Porzio Compliance Forum, Seton Hall Law, Center for Health and Pharmaceutical Law and Policy, Newark, NJ (October 30, 2014)

  • Presenter, How the US Sunshine Act and Global Transparency Trends will Impact Latin America, Latin American Pharmaceutical and Medical Device Compliance Congress, Mexico City, Mexico (July 30, 2014)

  • Co-Author,Getting the Deal Through-Life Sciences 2014, United States Chapter, published by Getting the Deal Through (2014)

  • Co-Author, Getting the Deal Through-Life Sciences 2013, United States Chapter, published by Getting the Deal Through (2013)

  • Co-Author, The Who, What, When and Why of the Sunshine Act, PM360 Magazine (June 1, 2013)

Involvement

  • The Minority Student Program, Rutgers U. School of Law, Mentor

Recent Representations

Legal and Regulatory Compliance Counseling

  • Secondments with four pharmaceutical / biopharmaceutical companies to date (including two rare disease companies, a leading HIV-focused company)

  • Serving on in-house review committees to assess medical / scientific and promotional materials (including reprints, responses to medical information requests, product dossiers, social media ads, patient testimonials / ambassador materials, speaker program decks, visual aids, patient support program materials) intended for HCPs, payors, patients / care partners, and PAOs

  • Supporting new product launches and providing guidance on preapproval communications strategies, including disease awareness materials

  • Reviewing, developing / enhancing, and implementing global compliance programs (e.g., manuals, field handbooks, policies, procedures, and guidelines) to mitigate risks, including risks related to (1) promotional interactions and programs; (2) engagements and interactions with HCPs, payors, PAOs, patients, and care partners; (3) medical and commercial joint interactions; (4) patient support program activities; (5) patient assistance funding; (6) research funding and activities; (7) external funding; (8) social media activities; (9) price reporting and marketing limitation and disclosure laws; and (10) third-party vetting, onboarding, and management (e.g., diagnostic / genetic testing labs)

  • Drafting and reviewing agreements, including fee-for-service, research, rebate and discount, and third-party agreements (manufacturer, wholesaler, and distributor)

  • Counseling a Japanese biopharmaceutical company on U.S. federal and state transparency laws, and state marketing code of conduct and gift limitation laws

  • Advising a multinational medical device company in an assessment of discount arrangements, aggregate spend data capture and reporting processes, state and federal marketing disclosure and limitation laws, and the enhancement of guidelines governing day-to-day interactions with healthcare professionals

  • Advising a multinational pharmaceutical company in an internal review of its patient support program, and anticipated compliance defenses in the event of an enforcement action in light of increased government scrutiny of the area and enhancement of guidelines governing day-to-day interactions with healthcare professionals and sales and marketing activities

  • Developing company-wide compliance training materials, as well as department-specific materials (including sales and marketing and medical affairs); training promotional speakers on company policies and procedures related to FDA-regulated promotion and permissible conduct

  • Advising pharmaceutical, medical device, and biotechnology companies on the continued enhancement of global ABAC compliance programs, including conducting proactive reviews, and advising on core program components such as monitoring, investigations, and remediation

Investigations and White Collar Defense

  • Represented a prominent U.S. pharmaceutical company in investigations by the DOJ and FDA across multiple offices into the post-marketing approval study and sales and marketing practices related to a Schedule II controlled substance

  • Represented a large pharmaceutical manufacturer in connection with a potential whistleblower threat relating to allegations of improper activity around the company's patient support program

  • Represented a Japanese multinational medical device company in connection with an investigation into senior executive whistleblower allegations concerning corruption and kickback issues in Latin America, the Middle East, and the United States, and associated review by statutory auditors

  • Assisted a multi-national rare disease company in ongoing resolution negotiations of an FCPA matter before the DOJ and SEC

Risk Assessments and Diligence

  • Conducted launch readiness compliance risk assessment in connection with launch of new product for U.S. healthcare subsidiary of German multi-national company

  • Conducted ABAC due diligence in connection with the multi-billion-dollar acquisition of multi-national orphan drug company in the following markets: Mexico, Spain, and Russia

  • Conducted ABAC due diligence in connection with the multi-billion-dollar acquisition of a multi-national injectable drug and biosimilar company in the following markets: Colombia and Argentina

  • Conducted ABAC due diligence in connection with multi-billion-dollar acquisition of multi-national company's consumer business in Colombia

  • Conducted proactive compliance market reviews on behalf of multi-national rare disease company in Colombia, the Netherlands, and the Nordics markets

Practice Areas

Litigation
Anti-corruption and FCPA
Life Sciences and Healthcare
Investigations and White Collar Defense
White Collar Defense

Languages

anglais
Spanish

Admissions

New York Bar

Education

Rutgers School of Law - Newark, J.D. 2011
New Paltz, State University of New York, B.A. 2007

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