Life Sciences companies 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. The lawyers in our FDA Regulatory and Enforcement practice leverage their experience as former executives and counsel at pharmaceutical and medical device companies, as well as in private practice, 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, as well as advising on a variety of FDA regulatory issues. Our team provides compliance and enforcement support for all aspects of the product lifecycle. Because of our team's unique backgrounds, we have a keen understanding of the FDA’s priorities and our clients’ needs, enabling us to guide companies successfully through the constantly changing regulatory and enforcement landscape.

Comprehensive Regulatory Experience

• We provide regulatory advice and strategic counseling throughout the product lifecycle, including questions related to product development, evidence generation, clinical trials, product approval or authorization, and post-marketing regulatory and competition issues.

• We are often called on to develop comprehensive strategies for, and responses to, Complete Response Letters and associated resubmissions, as well as to guide formal and information dispute resolution.

• 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. Our team also supports manufacturers in addressing agency meetings and responses to information requests.

• We conduct investment due diligence for FDA-related issues, including acquisitions of pharmaceutical and medical device companies, manufacturing sites, and products.

• We partner with our 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.

Guiding Clients Through the Enforcement Landscape

• Our highly experienced team draws on significant government and industry experience 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.

• Our lawyers 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.

• 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, and 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.