The complexity of food and drug laws and regulations and their implications on public health raise delicate legal questions for both regulators and companies in the pharmaceutical, health care, and food industries. Zuckerman Spaeder LLP’s food and drug law group represents generic and small biotechnology drug companies, nonprofits, advocacy organizations, state and local governments, trade associations, individuals, and other clients in a wide range of food and drug matters before courts across the nation, Congress, the Food and Drug Administration (FDA), and other federal agencies.
A number of attorneys in our Food and Drug Practice worked at the FDA. Our attorneys also have been involved in significant lawsuits and legislation during other stints in public service. Our food and drug attorneys have the substantive background knowledge necessary to deal with complicated scientific or technical subjects, including issues related to the chemical processes that underlie drugs’ efficacy, clinical trial design, federal health care programs, and the workings of the pharmaceutical marketplace. The attorneys in this practice combine their food and drug law expertise with broad litigation experience. The union of these two skill-sets enables us to give our clients a realistic evaluation of the strength of their position and to advocate on their behalf in many different arenas.
We represent clients on a wide range of issues before the FDA and in devising legislative strategies to advance our clients’ positions before Congress. Our representation includes assisting companies seeking FDA approval of new pharmaceuticals, navigating the administrative requirements of the FDA applications and presentations process, and addressing policy issues in FDA petitions and various proceedings before the agency.
The firm also represents businesses and individuals in claims of product liability, fraud, and violation of consumer protection statutes involving a large number of federal and state agencies. We counsel clients involved in investigations and defend allegations arising from other purported regulatory violations of the food and drug statutes.
Experience
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Represented a nationwide class that received an $18 million settlement in an ERISA matter in federal district court.
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Provided expert testimony at hearings on issues related to off-label promotion and cosmetic and drug advertising.
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Advised the New York City Board of Health on preemption case brought to block implementation of its requirement for labeling in restaurants.
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Filed an amicus curiae brief in the U.S. Supreme Court on behalf of Senator Edward M. Kennedy and Congressman Henry A. Waxman regarding preemption of state product liability claims brought in connection with defective medical devices.
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Represented a generic manufacturer that obtained a $3 million payment as compensation for lost profits during a temporary restraining order that prevented the FDA from approving the client’s generic version of a popular allergy drug. Zuckerman Spaeder also represented this client when it prevailed in defeating a motion for a preliminary injunction seeking to stop FDA from approving its generic.
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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.
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Acted as counsel to a state in efforts to facilitate the importation of prescription drugs from Canada.
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Represented leading public health group in legislation to give the FDA jurisdiction over tobacco products.
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Represented a leading generic manufacturer in negotiations regarding biogeneric legislation.
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Filed an amicus curiae brief in support of the current FDA standards regulating the use of experimental drugs that have not been approved, a position that was upheld in the U.S. Court of Appeals for the District of Columbia Circuit.
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Represented generic manufacturers in navigating the regulatory requirements at FDA.
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Represented generic manufacturers seeking generic exclusivity for a popular diabetes drug, a cholesterol lowering agent, and an epilepsy drug.
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Testified before Congress on pending legislation involving drug safety and drug imports.
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