Overview
For life sciences companies developing new technologies and treatments that improve lives, success hinges on far more than following the letter of the law. At Epstein Becker Green, we translate legal advice into practical action. Our team of lawyers and non-lawyer consultants and advisors offers real-world experience from careers in all corners of the life sciences industry.
We understand the unique legal, regulatory, compliance, operations, and technology challenges facing life sciences companies. Because of the diversity and breadth of experience of our Life Sciences team, we successfully meet the needs of our life sciences clients, from early pre-clinical research to commercialization and product launch through commercial operations, providing support for compliance with legal requirements over the entire product lifecycle. Our clients include pharmaceutical, biotechnology, medical device, and other life science industry companies.
Use Our Integrated Approach to Your Advantage
Life science companies require practical and comprehensive support as they discover, develop, and commercialize novel medical technologies to meet the needs of patients. Our attorneys partner with our affiliate, EBG Advisors, giving clients unrivaled access to non-lawyer consultants and advisors. Working as an extension of our firm, a diverse team of former physicians, health plan medical directors, reimbursement specialists, quality and regulatory experts, and government agency officials leverage their insight to tackle challenging regulatory hurdles.
Research and Development Solutions with Lasting Results
Tomorrow’s medical breakthroughs are founded on today’s innovative research. Clients turn to us for advice on the best way to secure investments for new research and to structure collaborative research and development transactions. We also negotiate collaboration terms, clinical site contracts, and services agreements with contract research organizations and other research services vendors.
Sophisticated Counsel for Corporate Transactions
Life sciences clients looking to grow or sell their companies count on us to help them evaluate targets for mergers, acquisitions, joint ventures, and sales, as well as to successfully structure and close their deals. We also represent private equity funds and other investors in financing transactions with life sciences companies. Because we have in-depth knowledge of the life sciences industry, and the laws and regulations that apply to it, we can easily spot and resolve potential problems that can arise during these transactions.
Corporate Compliance and Training Programs That Support Growth
In the fast-paced life science landscape, compliance programs are never static and may cover multiple jurisdictions spanning various supply chains and numerous third parties. While no two compliance programs are alike, risk management drives a company’s ability to anticipate enforcement agency priorities. We help clients define and assess their risks and develop compliance infrastructure and training programs that support their business goals.
Litigation and Dispute Resolution Services to Protect Your Interests
The complexity of the highly regulated life sciences industry has increasingly led to litigation among life sciences companies and their competitors, collaborators, consumers, and others, as well as by federal and state law enforcement agencies and qui tam relators. Our litigation attorneys, including some with high-level governmental prosecutorial backgrounds, are experienced in guiding life sciences clients through investigations, enforcement actions, and lawsuits. We represent and defend our clients in federal and state trial and appellate courts and before administrative and private tribunals in civil and criminal cases.
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Focus Areas
Services
- Academic and Clinical Research
- Artificial Intelligence
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Digital Health
- Drug and Medical Device Coding, Coverage, and Payment
- Drug and Medical Device Distribution
- Drug Pricing Policy & Reporting
- FDA Inspections and Enforcement
- Federal and State False Claims Act (Including Qui Tam)
- Federal Research Grants: Compliance, Investigations & Enforcement
- General Counsel Services
- Health Care and Life Sciences Investigations and Enforcement
- Health Care and Life Sciences Investor Services
- Health Care Mergers and Acquisitions
- Health Policy and Legislation
- Industry Research and Clinical Trials
- Life Sciences Due Diligence
- Mergers, Acquisitions & Divestitures
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
Industries
Experience
Our Team
Media
Events
Upcoming Events
Past Events
Insights
Insights
- BlogsPodcast: Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care2 minute read
- Media CoverageWilliam Walters Quoted in “Ruling Could Give Kennedy More Power Over Health Care Coverage”4 minute read
- Media CoverageRichard Hughes Quoted in “ACA Preventive Care Case Reaches Supreme Court”4 minute read
- Media Coverage
What's at Stake as Oral Arguments Are Presented in the Braidwood Case? Q&A with Richard Hughes, IV
4 minute read - Media CoverageRichard Hughes Quoted in “Supreme Court Grapples with Challenge to ObamaCare Preventive Care Panel”6 minute read
- Media CoverageWilliam Walters Quoted in “Supreme Court Appears Willing to Save ACA Preventive Services Task Force”3 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear Challenge to Obamacare Rule on Free Preventive Care”4 minute read
- Media CoverageRichard Hughes Quoted in “‘At the Mercy of Insurance Companies’: Supreme Court Braces for ACA Preventive Coverage ...4 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr. Attacks Environmental Toxins as Cause of Childhood Autism 'Epidemic', Stays Silent on ...8 minute read
- Media CoverageRichard Hughes Quoted in “On Autism, Experts Worry Kennedy May Pivot Back to Vaccine Claims”2 minute read
- Media CoverageJames Boiani Quoted in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?”2 minute read
- BlogsPodcast: Executive Actions Impact Federally Funded Research - What Institutions Should Do Now – Diagnosing Health Care2 minute read
- Firm AnnouncementsModern Healthcare Recognizes Epstein Becker Green Among Largest Health Care Law Firms1 minute read
- PublicationsThe LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold ...16 minute read
- BlogsCourt Sides with RICO Complainant Who Received Tainted Medical Marijuana and with FDA on Regulating E-Cigarettes - SCOTUS ...10 minute read
- Media CoverageJames Boiani Quoted in “Drug Industry Worries About FDA Delays”3 minute read
- BlogsPodcast: Criminal Health Care Fraud Enforcement - Projections for 2025 and Beyond – Diagnosing Health Care2 minute read
- BlogsA Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs2 minute read
- Media CoverageJack Wenik Quoted in “RFK Jr’s HHS Showing Mixed Signals for Dietary Supplement Sector”4 minute read
- Media CoverageLisa Pierce Reisz Quoted in “23andMe Bankruptcy Underscores Health Privacy Gaps”2 minute read
- Media CoverageMegan Robertson Quoted in “5 Tips for Building a Predetermined Change Control Plan”3 minute read
- BlogsThe End of the Self-Affirmed GRAS Pathway?5 minute read
- BlogsDEA Telemedicine Rules Further Delayed Until (Nearly) 20263 minute read
- Media Coverage
Epstein Becker Green's Health Law Advisor Cited in “Old Laws, Supreme Court May Stymie HHS Plan to Fast-Track Policy” ...
2 minute read - Media CoverageKate Heffernan Featured in “Can NIH Overturn a Court Order Blocking It from Slashing Overhead Payments? Unlikely, One ...5 minute read
- PublicationsWhat Does the Phrase “Resulting From” Mean? Circuit Courts Split on Standard for Determining When an AKS Violation Is a ...16 minute read
- BlogsHHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking7 minute read
- PublicationsProposed HIPAA Security Rule Updates May Significantly Impact Covered Entities and Business Associates20 minute read
- PublicationsExpanding Vaccination Provider Types and Administration Sites Can Increase Vaccination Uptake: A Systematic Literature ...2 minute read
- Media Coverage
Richard Hughes Discusses Why Payer Responsibility for Preventative Services May Hinge on Braidwood Management Inc. v ...
4 minute read - BlogsA Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule4 minute read
- BlogsFirst Circuit Joins Sixth and Eighth Circuits in Adopting “But-For” Causation Standard Under the Federal ...3 minute read
- PublicationsProtecting Newborns from RSV: Opening a Reimbursement Pathway2 minute read
- Media Coverage
Richard Hughes Discusses the Major Implications of Braidwood Management Inc. v. Becerra on Available Preventive Services ...
3 minute read - BlogsVideo: 2025 Outlook - the Department of Health and Human Services Under the Second Trump Administration – Diagnosing ...3 minute read
- BlogsIn Confirmation Hearings, AG Nominee Pledges to Defend the Constitutionality of the False Claims Act8 minute read
- BlogsAt Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming ...18 minute read
- Media CoverageRichard Hughes Quoted in “ACA Suit Threatens Overhaul of Preventive Care in Employer Plans”2 minute read
- BlogsDOJ’s False Claims Act Recoveries Top $2.9 Billion in FY 2024, but Health Care Numbers Dip—What Could FY 2025 Hold for ...4 minute read
- Media CoverageRichard Hughes Quoted in “How RFK Jr. Drove Mistrust of a Cancer Prevention Vaccine”7 minute read
- BlogsRecent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook6 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court Case Offers Trump Path to Dismantle Obamacare Mandates”5 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear ACA Preventive Coverage Suit”4 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear ACA Preventive Care Case”1 minute read
- Media CoverageRichard Hughes Quoted in “Biden Admin Finalizes NBPP, MA Pay Rules Ahead of Departure”2 minute read
- Media CoverageRichard Hughes Quoted in “SCOTUS to Review ACA’s Free Preventative Services Mandate”2 minute read
- BlogsSecond Circuit Adopts “At Least One Purpose” Rule for False Claims Act Cases Premised on Anti-Kickback Statute ...8 minute read
- Media CoverageMark Lutes Quoted in “What's Keeping Mid-Law Leaders Up at Night in 2025”2 minute read
- Media CoverageMegan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”2 minute read
- BlogsUnpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA13 minute read