Food and Drug

Overview

Arent Fox represents manufacturers and distributors of food, dietary supplements, pharmaceuticals, medical devices, cosmetics and chemical products. We counsel clients on regulatory compliance and product development, participate in agency rulemaking and adjudicatory proceedings, respond to federal and state enforcement efforts, and handle civil and criminal litigation.

Pharmaceuticals and Biologics

Our lawyers have significant experience in a wide variety of matters involving US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) regulation of pharmaceuticals, including pioneer and generic drugs, controlled substances and biologics, and over-the-counter drugs. We advise on product development and regulatory compliance. Recent product development-related activities include:

• Preparing orphan drug applications for a new cancer drug and a drug for Lyme disease
• Negotiating with the FDA over and assisting in the implementation of a clinical trial development program for a new drug (NDA recently approved)
• Counseling clients on ways to extend patent and exclusivity protection for drug products
• Advising universities on clinical research compliance
• Representing a client in several administrative hearings before a DEA administrative law judge on an application to import two controlled substances

In regulatory counseling, we advise clients on regulatory issues involving marketing and manufacturing of drug and biologic products. Recent regulatory-related activities include:

• Serving as regulatory counsel in support of drug developers’ initial public offerings
• Counseling a client on a nationwide recall of a drug product and limiting adverse publicity
• Conducting a worldwide audit of drug manufacturer’s adverse event reporting compliance
• Developing SOPs for post-marketing compliance issues affecting the promotion of pharmaceuticals
• Advising clients on federal and state pedigree and licensing requirements associated with drug distribution

Medical Devices

Arent Fox handles a wide variety of matters involving FDA regulation of medical devices, including product development and regulatory compliance counseling. We assist clients in product development, including coordinating with investigators, institutions and contract research organizations, drafting research and license agreements, representing companies before the FDA and appearing before advisory committees. Recent product development-related activities include:

• Securing FDA clearance of numerous pre-market notifications, including wound dressings and dental devices
• Advising clients on a variety of products and providing assurance that FDA pre-market notification was not necessary, including telemedicine products and numerous dental devices
• Preparing agreements with institutions and investigators for the development of cardiac and dental products

In regulatory counseling, we advise clients on regulatory issues involving marketed and investigational medical devices. We counsel clients on proposed advertising, labeling and promotional materials, including Web sites. Recent regulatory-related activities include:

• Drafting and submitting comments on proposed regulations involving dental devices
• Conducting a nationwide audit of a major device distributor, including on-site audits of eight facilities and document audits of 20 other locations
• Appearing before the FDA on the possible reclassification of a dental device product

Food and Dietary Supplements

Arent Fox represents manufacturers and distributors of finished human food and animal feed, human food and animal feed ingredients, and dietary supplements before the FDA and state and foreign regulatory authorities. We advise clients on a wide variety of issues, including product development, regulatory compliance and litigation.

In product development, we assist clients in developing strategic plans for the introduction of new food and dietary supplement ingredients and in analyzing the options available and the advantages/disadvantages of each. Recent product development-related activities include:

• Advising clients on the regulatory status of food ingredients, including products of biotechnology
• Overseeing toxicological testing of product ingredients and assisting in the review of safety data
• Convening expert panels to review the safety of food ingredients and product claims

In regulatory counseling, we advise clients on the marketing of foods and dietary supplements – such as proposed labeling, advertising and promotional materials, including materials for use on Web sites – to ensure compliance with applicable laws and regulations. Recent regulatory activities include:

• Advising a company on procedures for using the new qualified health claims on conventional food products
• Advising clients on crisis-management strategies, including how to respond effectively to adverse publicity concerning product safety or labeling
• Drafting and implementing standard operating procedures to respond to adverse product information, including the coordination of product recalls, market withdrawals and stock recoveries

Recent litigation-related activities include:

• Coordinating a large products liability claim against a food manufacturer
• Assisting a food distributor in the defense to a product liability claim

Cosmetics

Arent Fox represents manufacturers and distributors of cosmetic and over-the-counter drug products such as sunscreens, skin protectants and anti-acne products before the FDA and Federal Trade Commission. We counsel clients on regulatory compliance, participate in agency rulemaking, respond to federal and state enforcement actions and handle civil and criminal litigation.

Our cosmetics product practice provides counsel on FDA labeling and advertising compliance, claims substantiation issues, color additive issues, recalls, FDA inspections, ingredient nomenclature and many other issues.