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In Depth

Loeb & Loeb’s FDA Regulatory and Compliance Practice comprises an interdisciplinary team of regulatory, corporate, patent and litigation attorneys who advise clients on the full spectrum of legal and business issues related to the distribution and commercialization, including marketing and promotion, of FDA-regulated products. Focusing on the health and life sciences industries, including pharmaceuticals, biologics, medical devices, wellness products, dietary supplements and organics, the practice counsels clients on regulatory issues, compliance-related matters and risk management strategies; advises on laws and regulations related to product advertising and labeling; counsels on FDA exclusivity policies and related Hatch-Waxman issues; and provides representation in licensing transactions and regulatory enforcement actions.

Core service offerings include:

Compliance Counseling and Regulatory Defense
Loeb & Loeb provides a wide range of compliance counseling and regulatory defense services in connection with all manner of federal and state laws, guidelines and industry standards impacting 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.

Compliance Programs
We assist companies in preparing and implementing compliance programs, policies, standard operating procedures, work instructions and guidelines relating to all aspects of distribution and commercialization of FDA-regulated products.

Promotional and Scientific Review
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.

Privacy Counseling
We counsel on compliance with federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPPA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). 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.

Adverse Event Reporting and Response
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.

Contract Drafting, Review and Negotiation
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 healthcare 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.

Compliance Training and Workshops
Loeb & Loeb offers customized FDA compliance training for all levels, from field force employees to executives/boards of directors. Our tailored and comprehensive training programs cover such areas as 2003 OIG Guidance requirements, anti-kickback laws, false claims, promotional review, interactions with healthcare practitioners, speaker programs and sales representative activities.

Distribution and Licensing
We counsel wholesalers and manufacturers on the distribution and state licensing of pharmaceuticals, medical devices and equipment, human/non-human 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.

Auditing, Monitoring and Risk/Gap Assessment
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, adverse event practices, etc. We identify any potential gaps in compliance policies and procedures and assist our clients with corrective action.

Investigative Services
When allegations of misconduct arise, we conduct internal or independent investigations into Foreign Corrupt Practices Act (FCPA) violations, insider trading, money laundering and other fraud-related and white collar criminal matters. Our attorneys have a particular depth of experience leading anti-kickback, sampling, and off-label investigations on behalf of life sciences clients.

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