FDA Regulatory and Enforcement
Life Sciences clients face an increasingly complex and unpredictable regulatory and legal environment, and they need experienced counsel to help them navigate key questions and address potential enforcement risks. Our FDA Regulatory and Enforcement practice leverages deep Life Sciences expertise and a collaborative operating model to deliver tailored FDA regulatory, compliance, and enforcement support.
We have experience working with numerous FDA-regulated product types and technologies, spanning biologics, drugs, and devices. We advise on significant FDA regulatory issues and provide compliance and enforcement support for all aspects of the product lifecycle. Our lawyers provide creative and practical solutions to meet our client’s legal and compliance issues.
Paul Hastings Named to World's Top 10 Best Investigations PracticesGlobal Investigations Review
Successfully defended Eli Lilly against patent infringement allegations by Sanofi involving medical device and formulation patents relating to Sanofi’s largest selling insulin
Serve as lead counsel to a global pharmaceutical company across four continents in high-profile government investigations and internal reviews
Advised Merck & Co. on major cross-border M&A transactions including its strategic agreement with Quartet Medicine, acquisition of Afferent Pharmaceuticals, and acquisition of therapeutics pioneer Rigontec
Represented Deerfield Management in the launch of a first-of-its-kind research partnership with the Broad Institute of MIT and Harvard, aimed at solving complex, early-stage therapeutic challenges related to serious unmet medical needs
Represented the lead arrangers in a US$900M bank financing for Bain Capital Private Equity's and J.H. Whitney Capital Partners' acquisition of Epic Health Services and PSA Healthcare
The firm was named Life Sciences Litigation Firm of the YearManaging Intellectual Property
Tackling Industry Challenges with Core Competencies
We bring a global, interdisciplinary approach to support our life sciences and healthcare clients’ multifaceted needs. Our leading practice provides strategic legal counsel on critical intellectual property and helps clients navigate compliance, investigations, and enforcement issues, including FDA oversight throughout the product lifecycle. We also help clients structure transactions and financing arrangements, develop first-of-their-kind innovative strategic partnerships and licensing agreements, and advise on unique data governance issues, IoT development, and roll-out, as well as proactive privacy/cybersecurity assessments. Our leading lawyers also work closely with members of our Life Sciences Consulting Group to design, build, implement, and operate effective compliance risk management programs.
We partner with clients to understand and advise on their business and legal objectives, delivering tailored solutions, creative strategies, innovative value-add offerings, and seamless service across practices and regions. Our lawyers handle complex transactional, regulatory, and litigation matters, providing guidance and insight into the industry as a whole. The diversity of our cumulative experience allows us to be lean and targeted in our support.
Life Sciences Practice Group of the YearLaw360
A Leading FDA Regulatory Team with Deep Industry Experience
Our life sciences team includes former executives and counsel from pharmaceutical and medical device companies, as well as individuals with substantial private-practice experience. With this background, our team has a keen understanding of FDA’s priorities and our clients’ needs to guide companies successfully through the constantly changing regulatory and enforcement landscape.
Most Valuable Players -- Life Sciences and IPLaw360
Comprehensive Compliance and Enforcement Expertise
We provide regulatory advice throughout the product lifecycle, including questions related to product development, clinical trials, and product approval or authorization. We advise on communications with FDA and strategies for interfacing with the Agency, including preparing company executives and subject matter experts for significant FDA meetings. We also support manufacturers in addressing premarket issues, including, for example, pre-submission and post-submission meetings and responses to information requests as well as the development of comprehensive strategies for, and responses to, Complete Response Letters and associated resubmissions.
We have significant experience helping clients facing regulatory scrutiny related to their manufacturing processes. In addition to developing comprehensive and effective responses to challenging 483s, Untitled Letters, Warning Letters, and Import Alerts, we also support companies around the world in constructing rigorous action plans to demonstrate appropriate remediation and improvement, and prepare sites and personnel for successful regulatory inspections.
Our highly experienced team draws on significant industry expertise to counsel clients on effective strategies to identify and mitigate regulatory and legal risks. Our goal is to find practical ways to assess and sustain compliance.
We advise on product quality issues and, when needed, related field actions, including communications with regulators; as appropriate, we also coordinate with products liability and other counsel to reduce legal exposure, and develop coordinated approaches for addressing concerns from multiple, global health authorities.
Our lawyers conduct reviews of compliance controls based on current FDA enforcement trends and industry benchmarking. This includes reviewing controls related to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), data integrity, product promotion, safety reporting and vigilance, device tracking, and developing follow-up remediation plans with appropriate corrective and preventive actions to mitigate risks.
We conduct internal reviews on sensitive matters for alleged wrongdoing related to regulatory requirements, including allegations raised through compliance hotlines. This empowers us to defend clients in government investigations and qui tam litigation that allege violations of the Federal Food, Drug, and Cosmetic Act and other federal statutes.
Our team also defends clients in civil and criminal investigations by the DOJ into alleged violations of the Federal Food, Drug, and Cosmetic Act, Title 18, and related federal statutes. We handle DOJ actions related to FDA enforcement, including injunctions, product seizures, and consent decrees.
We conduct investment due diligence for FDA-related issues, including acquisitions of pharmaceutical and medical device companies, manufacturing sites, and products.