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Mayer Brown’s US Food & Drug Administration (FDA) Regulatory and Enforcement team assists companies of all sizes in their development and commercialization of products regulated by the US Food and Drug Administration (FDA), including pharmaceutical and biotechnology products, medical devices, food and beverages, cosmetics and dietary supplements, tobacco products and e-cigarettes, as well as with related regulatory inquiries involving the Federal Trade Commission and US Department of Justice. We have a particular focus on novel drug and biologic therapies, orphan drugs for rare diseases, and regulatory exclusivities.

We understand the challenges and opportunities that arise in a highly complex regulatory scheme and ensure that our clients are in compliance with FDA regulations across the entire product lifecycle, from research and development through clinical trials, FDA review and post-marketing. We work collaboratively with our clients to craft effective regulatory strategies for novel therapies and technologies, including combination products, cell and gene therapies, and biotechnology products.

Our deep understanding of the FDA Regulatory and Enforcement landscape allows us to guide companies through FDA interactions while avoiding many of the common pitfalls that can delay or derail product development. When obstacles do arise, we develop and implement effective strategies to overcome them, including meetings with agency stakeholders, informal and formal dispute resolution, and where necessary, administrative and litigation challenges to the agency. We also provide advice to companies and executives in government investigations, litigation, and related regulatory and enforcement inquiries implicating health, safety, and fraud laws.

We routinely work with M&A, Capital Markets, Emerging Companies & Venture Capital, and IP colleagues to advise Life Sciences clients on complex transactional matters, including mergers and acquisitions, licensing agreements, and a variety of funding transactions.

Experience

Pharmaceutical & Biotechnology

Assisted a global pharmaceutical manufacturer with patent listing issues across multiple therapeutic franchises, including responding to FTC and other third-party patent listing disputes.
Represented a mid-size pharmaceutical company in potential dispute regarding the scope of three-year exclusivity of a competitor’s product. Successfully persuaded FDA and CDER Exclusivity Board that client’s product was not blocked by the competitor’s exclusivity, enabling final approval of client’s product and avoiding potential litigation.
Obtained rare pediatric disease product designation for French pharmaceutical start-up.
Represented dozens of clients in obtaining orphan drug designation and exclusivity, including contested matters regarding prevalence, clinical superiority, and “same drug” comparisons.
Counseled a Japanese pharmaceutical company regarding orphan drug regulation in the United States, European Union, United Kingdom, Japan and China, including showing of “significant benefit” in the European Union.
Advised a global biotech company regarding alignment of IP and regulatory strategy to prevent approval of biosimilars with labeling carve outs/“skinny labeling.”
Represented a global biotechnology company in assessing opportunity for 12-year reference product exclusivity for biologic-biologic combination product, an issue of first impression at FDA.
Represented a clinical-stage pharmaceutical company in clinical trial development and expedited approval pathways, including Breakthrough and Fast Track Designation.
Represented a global specialty pharmaceutical company in evaluating five-year NCE exclusivity for oligonucleotide products.

Agri, Food & Beverage, Dietary Supplements, and Cosmetics

Counseled a Chinese client on resolving import alert regarding bulk dietary supplement shipments, with labeling remediation and justification for food additives.
With colleagues in United States and Germany, represented a Dutch infant formula manufacturer in addressing misbranding and illicit drop-shipping, as well as related contract disputes and potential litigation.
Advised Unilever Plc on the acquisition of Dr. Squatch personal care brand.
Represented Marubeni Corporation in acquisition of US-based Bubbies Homemade Ice Cream & Desserts Inc.
Advised US Foods in multiple transactions involving food manufacturers and wholesale suppliers.

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Experience

Pharmaceutical & Biotechnology

Agri, Food & Beverage, Dietary Supplements, and Cosmetics

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