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FDA Regulatory & Compliance

Overview

With mounting compliance pressures and an evolving and expanding body of laws and regulations governing the global health care industry, pharmaceutical and life sciences organizations are managing far more than just their product pipelines and daily business matters.

Loeb & Loeb’s FDA Regulatory and Compliance team advises clients on the full spectrum of legal and business issues related to the distribution and commercialization, including marketing and promotion, of FDA-regulated products.

We work with clients across the health and life sciences industries, from pharmaceuticals, biologics and medical devices to wellness products, dietary supplements and organics. We counsel on regulatory issues, compliance-related matters and risk management strategies; advise on laws and regulations related to product advertising and labeling; guide clients on FDA exclusivity policies; and provide representation in licensing transactions and regulatory enforcement actions, including implementation of corporate integrity agreements.

Our lawyers know the nuances of the law, and we understand the commercial challenges of the life sciences marketplace, including the business imperatives — and concerns — associated with compliance efforts. Functioning far more like an in-house legal team than a traditional private practice, our tight-knit group is accessible, pragmatic and committed to translating regulatory insight into practical advice to help our clients succeed.

For companies ranging from innovative biotech and medical device startups to top global pharmaceutical manufacturers — and those in between — Loeb lawyers serve as trusted business partners and advisers to address issues at every stage of the product life cycle. Our core service offerings include:

  • Loeb & Loeb provides a wide range of pre- and post-market compliance counseling and regulatory defense services in connection with federal and state laws, guidelines and industry standards impacting pharmaceutical, health and life sciences companies. We help our clients navigate the stringent and ever-changing regulatory landscape governing these industries, assisting them in achieving their business objectives while minimizing risk.
  • We assist companies in developing and implementing effective compliance programs, policies, standard operating procedures, work instructions and guidelines relating to all aspects of distribution and commercialization of FDA-regulated products.
  • Loeb & Loeb offers customized FDA compliance training for all levels, from field force employees to executives and boards of directors. Our tailored and comprehensive training programs cover areas including OIG guidance requirements, anti-kickback laws, false claims, promotional reviews, interactions with health care practitioners, speaker programs and sales representative activities.
  • Our attorneys regularly review promotional materials to ensure compliance with FDA requirements and to identify and mitigate potential product liability risks. We evaluate a wide range of materials, from product advertisements and social media activities to educational presentations and medical abstracts.
  • We counsel on compliance with federal and state privacy laws, including the Health Insurance Portability and Accountability Act, the Health Information Technology for Economic and Clinical Health Act, and the General Data Protection Regulation. We offer guidance on privacy considerations related to the use of digital and social media, mobile and internet-based communications, and electronic data collection and optimization strategies.
  • When adverse events occur, we advise clients on appropriate and compliant reporting and response, including with regard to labeling updates, documentation, FDA notification and monitoring services.
  • Our attorneys have extensive experience drafting, reviewing and negotiating a variety of contracts and agreements for manufacturers, suppliers, wholesalers and distributors of FDA-regulated products. These include contracts with health care practitioners, vendors, suppliers and other parties for product sales and marketing, distribution, intellectual property licensing, clinical trials, continuing medical education, and a range of other commercial services.
  • We counsel wholesalers and manufacturers on the distribution and state licensing of pharmaceuticals, medical devices and equipment, human/nonhuman tissue products, investigational products for clinical trials, and biologics. We also advise on issues related to direct-to-consumer dispensing, drug/device combination kits and sample product distribution.
  • Our proactive auditing services encompass all activities associated with the sale of regulated products, including marketing and advertising, social media, product sampling, general corporate practices and adverse event practices. We identify any potential gaps in compliance policies and procedures and assist our clients with corrective action.
  • When allegations of misconduct arise, we conduct internal or independent investigations into Foreign Corrupt Practices Act violations, insider trading, money laundering and other fraud-related and white-collar criminal matters. Our attorneys have experience leading anti-kickback, sampling and off-label investigations, and assisting life sciences clients with implementation of, and compliance audits related to, corporate integrity agreements.