Food and Drug

We are proud to be longtime advocates for generic drug manufacturers in their efforts to increase competition and bring affordable drugs to patients in need. We litigate cases in federal trial and appellate courts involving the Federal Food, Drug, and Cosmetic Act, especially the Hatch-Waxman and Orphan Drug provisions, related FDA regulations, and other federal and state statutory and regulatory schemes affecting the marketing of generic and orphan drugs.

Our litigators can help you in court when the stakes are high, fighting brand company tactics aimed at delaying generic competition, helping preserve or challenge Hatch-Waxman, orphan drug, and other statutory exclusivity rights, and challenging or supporting FDA regulations and policies. We also have extensive experience in pre-litigation advocacy for our clients in front of FDA—filing comments to proposed FDA rules and guidances, submitting and responding to FDA citizen petitions, and engaging the agency on critical regulatory and policy issues.

Zuckerman Spaeder is a nationally recognized litigation boutique, and our attorneys litigate civil and criminal cases in federal and state courts and in arbitration. 

We also represent FDA-regulated companies in internal and congressional investigations. In addition, with our deep white collar defense experience, we frequently represent pharmaceutical company executives and sales people in connection with government investigations.

Biosimilars is a rapidly growing area with many unsettled legal, regulatory, and policy questions. 

Zuckerman Spaeder has been involved in biosimilars regulatory and legal issues from the beginning, participating in drafting the legislation that created the biosimilars' pathway, litigating over the biosimilar law’s patent provisions, opposing citizen petitions aimed at crippling the FDA’s biosimilars approval regime, advising clients on product applications, and advocating for prompt patient access to affordable biologics.

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

We help generic pharmaceutical manufacturers to navigate the approval pathways using 505(j) and 505(b)(2) applications, advise medical device manufacturers (including medical app makers) about the 510(k) clearance and other paths to the market and assist biotechnology companies, especially in biosimilars-related issues.

When a deal involving an FDA-regulated entity is being negotiated, we help clients and their corporate lawyers to assess regulatory risks that might affect the transaction. Our attorneys understand the deal process and provide critical insight into how the FDA and other related federal agencies work.  

We have been involved in many transactions representing parties to large FDA-related corporate transactions and the investment banks that fund and structure these transactions. Large corporate law firms and Wall Street firms handling major stock or asset purchase agreements or joint ventures often hire us when pharmaceutical, medical device, dietary supplement, or cosmetic companies are involved. Our team conducts due diligence on potential regulatory issues involving the FDA, DOJ, USDA, and FTC.

Our attorneys advise on a variety of issues related to product safety and manufacturing. We assist companies with responding to FDA warning letters and “483s,” the development and implementation of risk evaluation and mitigation strategies (REMS), quality systems regulation, 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 on recall-related issues.

We work with clients to identify and mitigate the risks of disruptions caused by government investigations and actual or potential enforcement actions. We have experience negotiating broad consent decrees with the FDA and conducting internal investigations to head off compliance problems.

We represent nonprofit organizations, trade associations, food, drug and medical device companies, and other clients when they have interests in pending or potential legislation before Congress, or policy issues before FDA. 

Our attorneys bring to this work their experiences serving on Capitol Hill and in the executive branch. We have helped clients develop legislative strategies, prepare congressional testimony (or by delivering that testimony on their behalf), and draft proposed legislation.