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Food & Drug Administration (FDA) Regulatory

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2016 Litigation Year in Review

Mayer Brown’s US Food & Drug Administration (FDA) Regulatory practice includes lawyers from our offices throughout the Americas. In addition, our team includes lawyers in our Asia and Europe offices who have experience with counterpart regulatory bodies in a number of key markets. Our team combines regulatory experience, industry knowledge and scientific capabilities that allow us to handle any issue that our clients are facing. From routine counseling matters to bet-the-company crises, we understand our clients’ products and business goals and offer seamless, comprehensive counseling and sophisticated and effective advocacy.

Our team has extensive experience in all areas of food, drug and medical device regulation. We have represented clients in all phases of the product life cycle before the FDA, the Department of Agriculture (USDA), the Federal Trade Commission (FTC), the Drug Enforcement Agency (DEA), the National Institutes of Health (NIH) and the National Academy of Sciences (NAS), as well as the US State Department, the Commerce Department, the White House and both houses of Congress. We have also represented clients before counterpart agencies outside the United States, such as the European Medicines Agency (EMA or EMEA), National Competent Authorities (NCAs) and the World Health Organization (WHO).

We have represented clients on diverse issues related to product development, clearance and approval, clinical trials, biosafety, licensing agreements, manufacturer and distributor registration, government inspections, product and ingredient notifications and recalls, product corrective actions, regulatory and due diligence audits, labeling and promotion, Good Manufacturing Practices, Good Laboratory Practices and Quality Systems Regulation requirements. Our lawyers have defended clients against FDA enforcement actions, including seizure, product recalls, inspections and civil monetary penalties. We have managed FDA inspections of international supplier facilities in China and India, as well as advised foreign governments on revision and drafting of their food and drug laws.

We take a strategic, life-cycle approach to client counseling and advocacy. In addition to working with our clients to establish and maintain compliance with existing laws and regulations, we help them anticipate, adapt to and profit from changes in the legal and regulatory arenas as well as the public policy and legislative landscapes. We help clients craft innovative administrative, legislative or litigation approaches when the law is not clear, where there are seemingly irreconcilable multi-jurisdictional conflicts or where agency action is an issue.

Clients benefit from the perspective, analysis and judgment that we can provide thanks to our combination of education, training, skills and experience. Further, our team members bring extensive outside experience that includes previous positions as industry executives, in-house counsel, government or agency lawyers, physicians, scientists and public policy practitioners. In addition, our team is fully integrated with the myriad of other practice areas in the firm that service the health care and life science industries. Whether your business involves food, drugs, devices, biologics, combination products, cosmetics, veterinary products, dietary supplements or tobacco, our team offers experience and perspective on all of the industries that fall under the jurisdiction of FDA and its counterparts worldwide. Thus, our team is able to draw at once on an immense pool of talent and resources that can be tailored to fit each client’s needs and achieve its goals.

Pharmaceuticals and Biologics

Mayer Brown’s regulatory practitioners counsel and represent firm clients in matters involving the development of pharmaceuticals and biologics, including approval under, and compliance with, the Food, Drug, and Cosmetic Act and the Public Health Safety Act, statutory amendments such as Hatch-Waxman and the Biologics Price Competition and Innovation Act, and the various related regulations. Our team includes practitioners who have decades of regulatory experience, including government service. Team members have also held numerous high-ranking positions in industry and have highly technical medical and scientific education and training, which provides valuable perspective and insight for our clients.

Our work in this area spans every stage of the product life cycle. We advise on and prepare the universe of regulatory submissions pertaining to new product development and approval including the following:

  • Investigational New Drug Applications (INDs)
  • Preclinical and Clinical Studies
  • Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) protocols
  • 505(b)(1) and 505(b)(2) New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Biologics License Applications (BLAs)
  • 351(k) biosimilar applications

In concert with those processes, we advise on the multitude of available regulatory exclusivities, including those pertaining to New Chemical Entities (NCEs), New Clinical Studies (NCSs), ANDAs, Suitability Petitions, Orphan Drugs, Pediatric Drugs, Biosimilars and Interchangeable Biologics.

We also have extensive experience representing our clients with respect to Orange Book listings, Patent Term Extensions (PTEs), Drug Enforcement Agency (DEA) scheduling, Risk Evaluation and Mitigation Strategies (REMS), citizen petitions, agency meetings and appeals and agreements with third parties and vendors. Further, we assist with post-marketing compliance, including application supplementation, post-marketing surveillance, establishment registration, labeling, product listing, drug master files, Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) compliance and requirements for reporting of adverse events and other information. When necessary, we represent our clients in affirmative or defensive litigation and adversarial proceedings involving private parties and government agencies such as the US Food & Drug Administration (FDA). We also represent our drug clients before the FTC in advertising cases, including Lanham Act litigation, as well as before the National Advertising Division of the Better Business Bureau (NAD) with respect to challenged advertising claims.

Our lawyers have managed major international inspections for pharmaceutical manufacturers and their API manufacturers, including Chinese API manufacturers. We expect these inspections to increase in frequency and rigor as the FDA’s establishment of international offices continues, and we are well-positioned to help our clients manage these inspections, which are critical to the ability of a manufacturer to maintain ongoing compliance with the requirements of their NDAs.

We work strategically with our clients to assess legislation and proposed rulemaking affecting the industry. We advocate before lawmakers and agency personnel on behalf of our clients and prepare and submit citizen petitions and public comments. Additionally, we work closely with lawyers and others in our firm’s related practices—including Product Liability & Mass Torts, Intellectual Property, Supreme Court & Appellate, Corporate & Securities and Government Relations —to develop regulatory arguments designed to ensure that all critical issues are anticipated and addressed. This integrated, cross-disciplinary focus enables us to help our clients steer clear of inconsistent positions and to identify and implement their most beneficial overall legal and regulatory strategies for the entire product life cycle.

Medical Devices and Combination Products

Mayer Brown’s regulatory practitioners counsel and represent clients in a broad range of regulatory matters involving the development and marketing of medical devices, including compliance with the Food, Drug, and Cosmetic Act and related regulations, as well as European Union regulatory approvals and compliance issues. Our lawyers have extensive experience with medical devices and combination products, and our team includes medical doctors who have actually used many of these products. This broad industry experience allows us to provide our device clients with the insight and understanding that they need, whether they are startup device companies, universities and academic medical centers, or major multinational device makers.

Our group has experience working with a variety of devices and combinations, including all manner of traditional diagnostic and treatment instrumentation and implants, testing assays and imaging technologies, medical apps and software, Medical Device Data Systems (MDDSs), Health Information Technology (HIT) and combination device/drug, device/biologic and drug/biologic products. We advise on and prepare all premarket regulatory submissions, including pre-submissions, Investigational Exemptions (IDEs), Preclinical and Clinical Studies, Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) protocols, 510(k) Notifications, Premarket Approval Applications (PMAs), de novo applications and Humanitarian Device Exemptions (HDEs). We also assist with post-marketing compliance, including supplementation, post-marketing surveillance, establishment registration, product listing, inspections, Medical Device Reporting (MDR) and product recalls.

When necessary, we represent our clients in litigation and adversarial proceedings involving private parties and governmental agencies such as the FDA. We also represent our device and combination product clients before the FTC in advertising cases, including Lanham Act litigation, as well as before the National Advertising Division of the Better Business Bureau (NAD) with respect to challenged advertising claims.

Mayer Brown’s food and drug lawyers have decades of experience managing bet-the-company crises such as medical device recalls, detentions of product by FDA and Customs, Import Alerts, 483 responses, Warning Letter responses and consent decrees involving FDA and the Department of Justice. We have been involved on behalf of our clients in numerous recalls and enforcement actions, a critical aspect of our practice in view of the heightened enforcement environment for medical device manufacturers, both at the federal and state level, as well as internationally. We work with our clients to develop strategies not only for managing existing issues, but also establishing regulatory procedures to prevent future incidents. We also have significant experience helping our clients develop global regulatory systems and strategies to promote corporate-wide uniformity and compliance.

We work strategically with our clients to assess legislation, policy shifts and proposed rulemaking affecting their businesses, and we identify and execute the best actions to influence these processes for the benefit of our clients. Our efforts include advocating our clients’ positions with lawmakers and agency personnel as well as preparing and submitting citizen petitions and public comments. Additionally, we work closely with lawyers and others in our firm’s related practices—including Product Liability & Mass Torts, Intellectual Property, Supreme Court & Appellate, Corporate & Securities and Government Relations—to develop regulatory arguments designed to ensure that all critical issues are anticipated and addressed. This integrated, cross-disciplinary focus enables us to help our clients steer clear of inconsistent positions and to identify and implement their most beneficial overall legal and regulatory strategies for the entire product life cycle.

Food and Dietary Supplements

Mayer Brown’s regulatory practitioners regularly counsel clients on matters pertaining to food products, pet food products, medical foods, dietary supplements and food additives and ingredients as well as compliance with the Food, Drug, and Cosmetic Act, Dietary Supplement Health Education Act (DSHEA), Food Safety Modernization Act (FSMA), Fair Packaging and Labeling Act (FPLA), Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPRA or Bioterrorism Act) and similar statutes and related regulations, including regulations promulgated by the European Food Safety Authority (EFSA). Our lawyers have extensive experience in food law, regulation and policy and offer knowledge and insight gained from government service and positions in industry (e.g., serving as global director of regulatory affairs for several international food companies).

Our team provides counseling and representation to our clients in all areas of food law including product development, product safety, labeling requirements, promotion and advertising, Generally Recognized as Safe (GRAS) standards, product and facility inspections, recalls and other agency enforcement. We work closely with our clients to ensure compliance, including the audit and establishment of the full range of compliance programs, in order to mitigate the risk of enforcement actions or litigation.

Mayer Brown’s food and drug team includes lawyers who have decades of experience managing bet-the-company crises such as recalls, detentions of product by the FDA and US Customs and Border Protection, Import Alerts, 483 responses, Warning Letter responses and consent decrees involving the FDA and the Department of Justice. We have represented clients in most of the major recall events of the past two decades, and have successfully secured the release of goods in every FDA District and removed numerous domestic and international clients from Import Alert.

We work with our clients to develop strategies for managing existing issues as well as proactively establishing regulatory procedures to prevent future incidents. We also have significant experience helping our clients develop global regulatory systems and strategies to promote corporate-wide uniformity and compliance.

We develop strategies to advocate our client’s positions with regard to legislation and proposed rulemakings that affect the food industry, and have been instrumental over many years in shaping legislative and agency policies in numerous areas for the benefit of our clients. Our colleagues in the firm’s Government Relations and International Trade practices are well-versed in the issues that concern our food and dietary supplement clients. And as a result of their extensive experience at the World Trade Organization, Codex Alimentarius, the Department of Commerce and the Office of the United States Trade Representative (USTR), we have access to a diverse toolbox of strategies to accomplish critical objectives on behalf of our client companies and industry associations. With our industry understanding and insight, we anticipate trends and advise our clients on how to remain ahead of the regulatory and policy curves.

Finally, we have extensive experience representing our clients in affirmative and defensive litigation and adversarial proceedings involving private parties, quasi-judicial entities (such as NAD), and governmental agencies including the FDA and the FTC. Our regulatory practitioners also work closely with our renowned Food & Beverage Industry Class Action practice, which has represented many of the largest national and international food and beverage companies in the world in complex class actions. Over the past five years, the industry has faced a tidal wave of consumer lawsuits involving product labels and advertising, and we have worked closely in partnership with our clients to defend these matters and in many cases to obtain early dismissals through aggressive strategy and creative legal arguments. Our Food & Drug Administration Regulatory practice works seamlessly with our clients, our litigators and our Appellate team first to prevent issues that tend to lead to litigation and, when it does come about, to ensure that our entire team is engaged toward a successful outcome for our clients.

USDA

Since 1997, our FDA practitioners have represented clients before the USDA and its many agencies and offices, including the Animal Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), Food Safety and Inspection Service (FSIS), Foreign Agricultural Service (FAS) and National Organic Program (NOP), as well as international regulatory bodies, including Codex Alimentarius.

Some of the issues that we have brought before the USDA on behalf of clients include: nutrition and labeling; meat; poultry; perishable products; animal feed; organic agriculture; transgenic crops; plant pest; animal welfare; various permitting questions; product development; recalls; and international regulation. At the USDA’s invitation, we have participated in numerous US delegations to other nations to provide testimony and meet with government officials.

Our practice involves a range of activities, including day-to-day compliance issues, administrative proceedings and litigation, and long-term planning for corporations that are working through issues involving transgenic crop policies. We leverage our experience working with the FDA and the FTC in order to provide our clients a holistic approach to assessing and managing the complexities of a multi-agency regulatory regime in order to achieve their business objectives.

Veterinary Drugs

Mayer Brown’s regulatory practitioners counsel clients on all areas of the US Food & Drug Administration's (FDA) regulatory authority over veterinary drug products under the Food, Drug and Cosmetic Act and related regulations. We have assisted our clients with respect to New Animal Drug Applications (NADAs), Abbreviated New Animal Drug Applications (ANADAs), Conditional Approvals (CNADAs), designing and conducting clinical studies for new animal drugs, Green Book listings, exclusivity issues under the Generic Animal Drug and Patent Restoration Act (GADPTRA) and responding to FDA warning letters and enforcement actions. We also represent our veterinary drug clients before the FTC in advertising cases, including Lanham Act litigation, as well as before the National Advertising Division of the Better Business Bureau (NAD) with respect to challenged advertising claims.

Cosmetics

Mayer Brown’s regulatory practitioners represent clients in matters involving US federal and state laws and regulations pertaining to cosmetics, including compliance with the Food, Drug, and Cosmetic Act (FDCA), Food Safety Modernization Act (FSMA), Fair Packaging and Labeling Act (FPLA), advertising and social media issues and similar statutes and related regulations in the United States and other key international markets.

Our team provides counseling and representation in all areas of cosmetics law, including the regulatory distinction between cosmetics and drugs, cosmetic safety issues, Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), ingredient status, approval of color additives, labeling and packaging issues and responses to warning letters and product recalls. We represent our clients before the FTC in advertising cases, including Lanham Act litigation, as well as before the National Advertising Division (NAD) of the Better Business Bureau with respect to challenged advertising claims.

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