On both sides of the Atlantic, the health care and life sciences industry must deal with changing legislation and regulation – and the possibility of ground-shifting judicial decisions. Our team is focused on keeping clients abreast of the developments that matter. We clearly and concisely explain their impact, and help clients determine and implement the most advantageous strategy for their businesses.
United States
In the United States, our regulatory team monitors a broad spectrum of both state and federal legislative and agency activity of interest to clients, including thoroughly tracking federal legislation as well as regulatory and enforcement developments from all divisions of the Department of Health and Human Services (including the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA)). On the state level, we maintain dedicated legislative and regulatory trackers for key issues, including reproductive health, gender-affirming care, pharmacy reimbursement, regulation of PBM practices, and health care transactions, providing clients with timely updates on legislative and regulatory changes across jurisdictions.
Meanwhile, our product liability team tracks key dockets and opinions, closely monitoring for the developments that impact our clients.
We keep clients informed on how these changes will affect their businesses through timely client alerts, CLE webinars, and our popular blogs, Health Industry Washington Watch and Drug and Device Law. We also leverage these insights to develop bespoke training for our clients’ in-house and business teams.
Where clients seek to influence legislation, regulation, or judicial decisions, we offer hands-on support, including:
- Helping develop policy proposals
- Drafting and submitting comment letters on proposed rules
- Drafting talking points and position papers
- Preparing clients for meetings with government officials
- Drafting proposed legislative and regulatory language
- Authoring proposed legislative amendments
- Drafting and filing amicus briefs
- Providing written comments or testimony to Judicial Conference advisory committees on proposed amendments to federal rules
We regularly collaborate with leading industry advocacy groups and organizations and their members to advance positions beneficial to the entire industry.
European Union
In the EU, our team closely monitors developments from the European Commission and the co-legislators (the European Parliament and the Council) across the pharmaceutical and medical devices sectors. Through proactive horizon scanning of proposals, communications, delegated and implementing acts, and committee activity, we identify emerging trends and regulatory shifts at an early stage, including on topics such as pharmaceutical law reform, supply shortages and critical medicines, health technology assessments, and the Biotech Act. We also track cross-sectoral policy and legislative developments that may impact the life sciences sector, such as potential PFAS restrictions, the AI Act, and the new European Product Liability Directive.
We conduct impact assessments to translate policy and legal developments into concrete business implications, advising on operational, compliance, market access, and supply chain considerations. We also engage with Brussels-based industry associations and stakeholder coalitions to inform our analyses and enable clients to contribute effectively to the policy dialogue.
