Sandra González is an associate in the Litigation practice of Paul Hastings and is based in the firm’s New York office.

Ms. González counsels pharmaceutical, medical device, and biotechnology companies on a variety of compliance-related issues, including federal and state fraud and abuse laws, FDA promotional regulations, industry standards regarding healthcare professional (“HCP”) interactions, sample compliance, and anti-corruption and anti-bribery laws, including the Foreign Corrupt Practices Act and the UK Bribery Act. Her experience includes:

Advising pharmaceutical, medical device, and biotechnology companies on the continued enhancement of global anti-bribery and anti-corruption compliance programs, including conducting proactive reviews, and advising on core program components such as monitoring, investigations, and remediation.
Serving on in-house review committees to provide legal or regulatory review and assessment of branded and unbranded promotional materials (including ads, print materials, speaker program presentations, managed care materials, and social media) and marketing activities directed towards consumers and HCPs, as well as sales training materials and scientific communications; supporting new product launches and providing guidance on lawful preapproval communications strategies, including disease awareness campaigns.
Drafting, editing, and reviewing compliance and ethics manuals, field handbooks, policies, procedures, and guidelines in areas of promotion, off-label communications, consultants and speakers, HCP interactions, privacy, patient assistance programs, medical science liaisons, dissemination of medical/scientific information to HCPs, research activities, grants and charitable contributions, training, monitoring, investigations of suspected non-compliance, disciplinary measures, and enforcement procedures; developing compliance implementation plans with milestones to assess progress.
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.
Conducting investigations into payments to HCPs in violation of state gift limitation and ban laws.
Performing audits, gap analyses, and risk assessments of overall compliance programs, sampling activities, and disclosure reporting and gift limitation compliance; drafting and presenting executive summaries of audit and assessment results.
Drafting and reviewing agreements, including fee-for-service, clinical study,
investigator initiated study, and third party (manufacturer, wholesaler, and distributor).