Companies and individuals doing business in the U.S. food, drug, and medical device industries face an array of complex legal challenges relating to regulation by the U.S. Food and Drug Administration (FDA) and 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.
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.”
Regulatory Counseling
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 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:
- Represented a generic manufacturer in obtaining FDA approval for generic versions of blockbuster cholesterol drugs.
- Helped obtain FDA approval of drug product after the FDA questioned the sufficiency of the client’s clinical trials.
- Represented a medical device manufacturer in successfully reclassifying its product from premarket approval application (PMA) to 510(k) status.
- Assisted a client with due diligence in connection with its purchase of a cosmetic manufacturer.
- Acted as counsel to a state government in efforts to facilitate the importation of prescription drugs from Canada.
- Represents the Reagan-Udall Foundation, a statutorily created 501(c)(3) organization charged with assisting FDA in its mission to advance regulatory science.
Litigation
Zuckerman Spaeder’s food and drug attorneys have extensive experience litigating cases in federal trial and appellate courts in high-stakes litigation involving the Federal Food, Drug, and Cosmetic Act, FDA regulations, and other 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 lower appellate courts 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 regulatory “citizen petition” process.
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.
Experience:
- Successfully defended a drug manufacturer’s right to 180-day exclusivity for its generic version of a blockbuster cholesterol drug against a federal court challenge by a generic competitor.
- Successfully defended the FDA’s approval of a client’s generic version of a popular allergy product against a federal court challenge by the manufacturer of the branded version of the product, obtaining a $3 million payment as compensation for lost profits during a temporary restraining order that prevented the FDA from approving the client’s product.
- Successfully represented a generic drug manufacturer in the U.S. Supreme Court in a case addressing whether federal law preempted state failure to warn actions against generic manufacturers.
- Defeated a “citizen petition” seeking the FDA’s ruling that a generic client forfeited its right to 180-day generic exclusivity.
- Filed an amicus curiae brief in the U.S. Supreme Court for Rep. Henry Waxman in Caraco v. Novo Nordisk (pending), which concerns the interpretation of the generic counterclaim provisions of the Hatch-Waxman law.
- Represented a state in one of the first cases against the makers of OxyContin, helping to secure a large settlement just prior to jury selection.
- Represented the manufacturer of a medical abortion drug in Freedom of Information Act (FOIA) litigation to protect confidential commercial information, as well as employee and patient identifying information.
- Advised the New York City Board of Health on preemption case brought to block implementation of its requirement for food nutritional content labeling in restaurants.
- Represented an individual who was targeted in an FDA injunction; the individual was ultimately not named as a defendant in the FDA consent decree.
- Represented an individual in a criminal investigation involving the sale of an unapproved drug product; the individual ultimately was not charged.
- Defended a group of sales executives at a large pharmaceutical manufacturer in a criminal investigation regarding off-label promotion of several products.
- Defended the former vice president of sales for a large pharmaceutical manufacturer in parallel civil and criminal investigations regarding off-label promotion of a drug.
- Represented a prominent orthopedic surgeon in a criminal investigation of potential Anti-Kickback Act violations stemming from consulting relationships with manufacturers of medical devices and prosthetic implants.
- Represented the founder and former chief executive of a named defendant corporation in a qui tam action in the U.S. District Court for District of Massachusetts.
- Represented pediatric dentists in criminal and civil investigations into allegations of Medicare and Medicaid fraud stemming from the provision of unnecessary procedures and improper billing practices.
Compliance
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, we counsel clients in matters related to recalls.
Experience:
- Negotiated a consent decree for a large generic drug manufacturer.
- Helped coordinate an international generic drug manufacturer’s efforts to assess and ensure regulatory compliance in foreign markets.
- Conducted an internal investigation regarding alleged off-label marketing practices.
- Represented a client in a matter before the Consumer Product Safety Commission involving a massive recall affecting 3 million units.
Legislative/Policy
Zuckerman Spaeder’s Food and Drug Practice represents nonprofit organizations, food, drug and medical device companies, trade associations, and other clients when they have interests in pending or potential legislation before Congress, or policy issues before the FDA. 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:
- Advised a generic drug trade association on issues relating to generic drug approval and was the lead presenter for generic interests at a daylong FDA symposium on the subject.
- Provided expert testimony at congressional hearings on issues related to off-label promotion and cosmetic and drug advertising.
- Testified before the Senate Committee on Health, Education, Labor and Pensions and the Senate Judiciary Committee regarding patent and exclusivity provisions in proposed bioterrorism legislation.
- Testified before Congress on pending legislation involving drug safety and drug imports.
- Represented a leading public health group in negotiations over legislation to give the FDA jurisdiction over tobacco products, culminating in enactment of the 2009 tobacco legislation.
- Represented a leading generic manufacturer in negotiations regarding biogeneric legislation.
- Represented companies in responding to and heading off congressional investigations.