Life Sciences & Healthcare Regulatory
Arnold & Porter's renowned Life Sciences and Healthcare Regulatory practice is unique in providing a fully integrated team focused on delivering comprehensive and sophisticated assistance to clients in all areas of life sciences product and healthcare regulation. Our clients include manufacturers of pharmaceutical, biotechnology, medical device, and diagnostic products; healthcare professionals; universities; and leading trade and professional organizations. We also represent companies in the food, dietary supplement, over-the-counter drug, and cosmetic fields. Our practice supports virtually every aspect of our clients' regulated business activities, including U.S. FDA, EU, UK, and China regulatory strategies; clinical trials; inspections; promotion and advertising; exclusivities; fraud and abuse; pricing; contracting; coverage and reimbursement; domestic and global compliance programs; government investigations; transactional diligence and post-transaction integration; and public policy advocacy.
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Decades of Experience: Our global team has handled the most challenging life sciences and healthcare regulatory matters, from high-profile global regulatory investigations to unprecedented strategies for obtaining approval.
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Deep Knowledge of Government and Science: Our highly experienced lawyers and other professionals are thought leaders in the field; many have senior government, in-house, and corporate professional experience, as well as advanced degrees in diverse scientific and medical fields.
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Global in Scope: Our practitioners in the U.S., Europe, the UK, and Asia routinely handle global regulatory challenges for our clients, from compliance program development to simultaneous regulatory inspections.
Experience Highlights
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Lead counsel for requestors in connection with multiple advisory opinions issued by the Office of Inspector General (OIG) of the U.S. Department of Health and Human services.
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Takeda in connection with the collection and use of real-world evidence and patient-reported treatment outcomes for R&D, and advising on EU ethical and regulatory considerations, as well as compliance.
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Several multinational pharmaceutical companies, including Janssen, Sanofi, UCB Pharma, and Incyte, in separate matters involving health technology appraisals of their respective medicinal products before the NICE Appeal Panel.
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Pharmaceutical Research and Manufacturers of America challenging Inflation Reduction Act involving price setting for Medicare Part D and Part B drugs and subsequent appeal to the Fifth Circuit, which remanded the matter for proceedings on the merits.
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Johnson & Johnson regarding a number of high-profile matters relating to the 340B program, including the company’s proposal to adopt a rebate model for certain 340B transactions.
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Large pharmaceutical company in responding to FDA inspections and resulting compliance actions regarding numerous manufacturing facilities, including developing and implementing a remediation plan and conducting internal investigations.
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Biopharmaceutical company in the complex launch of an innovative new drug for Alzheimer’s, including navigating accelerated approval, labelling, coverage and reimbursement, promotion, patient support, and a range of issues associated with this critical treatment.
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Global pharmaceutical company in a multifaceted effort seeking enforcement against the unlawful marketing and sale of compounded weight loss drugs presenting significant public health issues due to substandard or inactive compounded products.
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Numerous pharmaceutical companies regarding the impact of pending legislation on their relationships with Chinese entities providing services and equipment, including adapting agreements to avoid negative impacts on product development.
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Pharmacosmos A/S, in its acquisition of G1 Therapeutics Inc., for a total equity value of approximately $405 million; and assisting in crucial post-closing regulatory, market, and compliance integration.
Focus Areas
- Clinical Research
- Pharmaceutical Product Pricing & Contracting
- Coverage & Reimbursement
- Compliance and Fraud & Abuse Counseling
- Life Sciences and Healthcare Investigations and Litigation
- Life Sciences and Healthcare Due Diligence and Integration
- European Union/UK Product Life Cycle Regulation
- China Life Sciences Regulation and Compliance
- Healthcare Providers, Suppliers and Delivery Systems
- Healthcare Government Investigations
- Healthcare Privacy and Data Security
- Diagnostics and Clinical Laboratories
Key Contacts
Related Services
Recognition
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Chambers EuropeLife Sciences – Europe-wide (2025)
Life Sciences/European Law – Belgium (2025)
Life Sciences – Netherlands (2025) -
Chambers UKLife Sciences – UK-wide: Band 1 (2024)
Life Sciences: Product Liability – UK-wide: Band 1 (2024)
Life Sciences: Regulatory – UK-wide: Band 1 (2024) -
The Legal 500 USHealthcare: Life Sciences (2024)
Healthcare: Service Providers (2024) -
Chambers GlobalLife Sciences – Global-wide (2025)
Life Sciences – Europe-wide (2025)
Life Sciences and Pharmaceutical Sector: International and Cross-Border – UK (2025)
Life Sciences and Pharmaceutical Sector: International and Cross-Border – USA (2025)
Life Sciences: Regulatory/Compliance – USA (2025) -
Chambers Greater China RegionLife Sciences: International Firms – China (2025)
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The Legal 500 Asia-PacificLife Sciences and Healthcare: Foreign Firms – China (2023)
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Law360"Practice Group of the Year" (2022)
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LMG Life Sciences GuideHealthcare: Pricing and Reimbursement (2024)
FDA: Pharmaceutical (2024)
FDA: Medical Devices (2024) -
The Legal 500 UKIndustry Focus: Life Sciences and Healthcare (2023)
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Chambers USAHealthcare: Highly Regarded – Nationwide (2024)
Healthcare: Pharmaceutical/Medical Products Regulatory – Washington, D.C. (2022-2024)
Healthcare – Washington, D.C. (2022-2024)
Life Sciences – Nationwide, California (2022-2024)
Life Sciences: Regulatory/Compliance (Nationwide) (2022-2024) -
Above the Law"Outside Counsel Rankings" Top counsel in Healthcare/Life Sciences (2021)
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Managing Intellectual Property"U.S. Firm of the Year" Life Sciences IP Litigation (2021)
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Chambers Asia-PacificLife Sciences (International Firms) (2021)
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U.S. News & World Report and Best Lawyers"Best Law Firms" FDA Law – Washington, D.C., National (2024)
"Best Law Firms" Healthcare Law – Washington, D.C., National (2024) -
LMG Life Sciences AwardsLife Cycle Firm of the Year - United States (2022-2023)
Regulatory Firm of the Year (2023)
