We pride ourselves on providing top-notch regulatory and compliance counsel, and helping clients implement our legal advice into their systems, processes, and technologies.
We advise clients throughout the life sciences industry – including pharmaceutical, biotech, medical device, digital health, and AI companies – in a range of areas, including:
Conflicts of interest (fraud and abuse law) and transparency
Counseling life sciences clients inevitably involves assessment of clients’ activities in relation to anti-kickback and transparency laws, as well as self-regulation through pharmaceutical and MedTech codes of conduct.
Our experience includes a heavy focus on manufacturer relationships with their customers and other referral sources. We have represented pharmaceutical and medical device manufacturers in virtually every clinical area, and are well acquainted with the typical promotional strategies and tactics in individual product and therapeutic area sectors. Our understanding of both the seller’s and buyer’s perspective means we can counsel clients pragmatically in the substantial gray areas of anti-kickback compliance.
In the United States, we provide fraud and abuse counsel in a wide array of matters, including those involving spokesperson agreements, product development arrangements, and clinical studies. Our advice considers and incorporates federal and state laws, as well as OIG guidance and industry codes, including the PhRMA and AdvaMed Codes. We also help compliance teams work through potential kickback issues and conflict of interest policies, on-label and off-label marketing and promotion issues, incentive compensation for sales representatives, reimbursement support and services programs, and more.
Additionally, we have in-depth knowledge of U.S. transparency requirements, including the Physician Payments Sunshine Act (aka Open Payments) and similar state laws. We analyze these laws’ applicability to clients’ operations, develop and implement related policies and procedures, and provide training. We regularly advise clients regarding the reportability and proper characterization of payments and transfers of value (or ownership interests). Such analyses are often conducted in conjunction with fraud and abuse analyses, and we have assisted companies in developing dynamic compliance dashboards utilizing Sunshine and other business data. Given the range of clients we represent, we have strong benchmarking capabilities when it comes to considering unique issues and questions.
In the EU, we review and revise agreements with health care professionals, health care organizations, key opinion leaders, patient organizations, and individuals for compliance with transparency and anti-kickback legislation as well as industry codes of conduct such as the EFPIA Code of Practice and the MedTech Europe Code of Ethical Business Practice. We draft and negotiate a variety of fee-for-service agreements, including speaker/consultancy agreements. We also assess clients’ internal processes and procedures in relation to sponsorships and educational grants; participation in congresses and other medical education events; royalties for product development; gifts and donations; hospitality, travel, and other expense reimbursement; and demonstration products.
Additionally, our Paris team has deep experience with the “French Sunshine Act,” and related anti-gift laws, and regularly counsels life sciences companies on its implications. Our French lawyers often prepare and submit reports to the Transparence Santé website on our clients’ behalf.
Compliance programs
We frequently analyze and stress test our clients’ key strategic initiatives and advise on legal compliance and risk management. In fact, we regularly advise on the soundness of the business strategies themselves, as well as the operational and compliance infrastructures in place to support the business initiatives. For our clients, we bring industry-leading experience in life sciences and health care compliance. As strategic legal advisors, we not only help scope the opportunity, but also mitigate the risks of innovating and operating in a highly regulated and competitive industry.
In the United States, building on the Federal Sentencing Guidelines and relevant compliance program guidance from the Department of Health and Human Services (HHS) Office of Inspector General (OIG), as well as best practices applicable to the client’s industry sector, we have assisted nearly every type of entity operating in the life sciences and health care industry in developing, implementing, and maintaining effective compliance programs and in addressing compliance program issues as they arise.
In the EU, building on the EU medical device and in vitro diagnostic frameworks and pharmaceutical legislation, and oversight by the European Medicines Agency (EMA), national competent authorities, and notified bodies, we have assisted various life sciences companies with compliance program issues. In doing so, we align programs with regulator-issued guidelines that can serve as templates for internal policies, procedures, and standard operating procedures, and we leverage internationally recognized standards (such as ISO) to demonstrate conformity and sustain robust, well-documented controls across the product lifecycle.
FDA and EU regulatory, compliance, and enforcement
Please see our FDA & EU Regulatory, Compliance, and Enforcement page for details.
Government and internal investigations
Please see our Health Care & Life Sciences Investigations page for details.
Pricing and reimbursement
Please see our Drug & Device Pricing and Reimbursement page for details.
