Food & Drug

Overview
Civil Litigation
Counseling
White Collar & Investigations
Regulatory & Compliance

Companies, individuals, and other stakeholders involved in the U.S. food, drug, and medical device industries and other sectors regulated by the U.S. Food and Drug Administration (FDA) face an array of complex legal challenges relating to FDA regulation, regulation by other federal, state, and local agencies; actual or potential civil litigation; government investigations by the U.S. Department of Justice (DOJ) and other law enforcement agencies; and legislative and policy issues. Zuckerman Spaeder LLP’s Food and Drug Practice represents clients in all these matters—in the courts, before FDA, DOJ, and other government agencies, and in Congress. Our clients include brand-name and generic pharmaceutical, medical device, cosmetic, over-the-counter medication, biologics, and food companies and their executives, as well as nonprofit organizations, trade associations, government agencies, and members of Congress that are involved in FDA-regulated matters.

Zuckerman Spaeder’s food and drug attorneys have vast experience helping their clients navigate the complex FDA regulatory environment and are well-versed in the scientific and technical subjects that lie at the heart of many of the issues facing their clients in that environment, such as the requirements for clinical trial design, the hurdles to product approval, the pitfalls attendant to participation in federal health care programs, and the workings of the pharmaceutical marketplace. They are also experienced litigators who have proven track records of successfully advancing their clients’ interests in court. Many of the firm’s food and drug attorneys also have previous experience working in the executive and legislative branches of government that they can bring to bear on the problems facing their clients. The firm has been recognized for FDA law in both editions of U.S. News and World Report’s “Best Law Firms.”

Experience Highlights

Zuckerman Spaeder’s food and drug attorneys have extensive experience litigating cases in federal trial and appellate courts in high-stakes litigation involving the Hatch-Waxman provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), other aspects of the FDCA, FDA regulations, and other federal and state statutory and regulatory schemes.

Our food and drug attorneys have represented numerous generic pharmaceutical manufacturers in high stakes Hatch-Waxman ‎litigation, successfully obtaining for their clients (or denying their clients’ competitors) valuable statutory marketing exclusivities. We have enjoyed success challenging (or upholding) FDA’s regulatory decisions and standards in the courts—for example, defending FDA’s approval of our clients’ generic drug applications against court challenges brought by brand company manufacturers seeking to foreclose the competition posed by generic versions of their products. Our attorneys have filed numerous amicus curiae and party briefs in the U.S. Supreme Court and the federal courts of appeal on such issues as federal preemption in the food and drug area, the interpretation of the counterclaim provisions of the Hatch-Waxman law, and the regulation of tobacco products under the 2009 tobacco legislation. We also bring our advocacy skills to bear in pre-litigation matters before FDA—for example, in matters reviewed by the agency through the “Citizen Petition” process.

Experience

Zuckerman Spaeder’s food and drug attorneys counsel clients at every stage of the FDA regulatory process, from initial efforts to obtain agency approval for their products to post-marketing issues.

Our attorneys have extensive experience working with generic pharmaceutical manufacturers to navigate the approval pathways for generic drugs using 505(j) and 505(b)(2) applications. They also have broad experience working with medical device manufacturers in pursuing FDA approvals and assist biotechnology companies in the cutting edge area of “biosimilars.” We also counsel food, drug, and medical device industry clients with respect to labeling, marketing, and FDA post-market surveillance.

Our attorneys also help their food and drug clients find solutions to business challenges, including advising or performing due diligence for companies seeking financing or considering mergers or acquisitions. In addition to their work assisting domestic pharmaceutical and medical device manufacturers navigate business and regulatory issues, our attorneys counsel international companies preparing to bring products to market in the United States.

Experience

More and more frequently, the government is targeting not just companies, but also individuals for enforcement actions. Recent years have seen more food and drug industry executives charged with civil and criminal offenses related to alleged professional misconduct. With a nationally recognized White Collar Practice, Zuckerman Spaeder is uniquely positioned to represent individual clients facing these types of cases and has represented a number of pharmaceutical company executives and sales people in connection with government investigations of off-label promotional activities. We also have experience representing companies in responding to and heading off congressional investigations.

Experience

Zuckerman Spaeder’s Food and Drug Practice works with clients to identify and mitigate the risks of disruptions caused by government investigations and actual or potential enforcement actions. It has experience negotiating broad consent decrees with the FDA and conducting internal investigations to head off compliance problems. Our attorneys also advise companies on a variety of issues related to product safety and manufacturing. We assist companies with responding to FDA warning letters and “483’s”; the development and implementation of risk evaluation and mitigation strategies (REMS); quality systems regulation (QSR); and meeting good manufacturing practices (GMP) obligations. In the event that products are found to be unsafe or otherwise unsuited for the market, we counsel clients in matters related to recalls.

Our attorneys also represent nonprofit organizations, food, drug and medical device companies, trade associations, and other clients on matters related to the FDA, including when they have interests in pending or potential legislation before Congress, or policy issues before the agency. Our attorneys bring to this work their experiences serving on Capitol Hill and in the executive branches of state or federal governments. We have helped clients develop legislative strategies, prepare congressional testimony (or by delivering that testimony on their behalf), and draft proposed legislation.

Experience

Offices