Mayer Brown expands FDA regulatory capabilities with addition of George O'Brien
Mayer Brown announced today that George O’Brien has joined the firm as a partner in the Corporate & Securities practice in Washington DC, where he will focus on a wide range of matters relating to the development, manufacture and marketing of products regulated by the Food and Drug Administration (FDA) for the firm’s clients in the life sciences and food and beverage industries. Mr. O’Brien joins from Hogan Lovells, where he was a partner.
“We are delighted to have George join our team,” said Reb Wheeler, a co-leader of Mayer Brown’s global Life Sciences group and leader of the firm’s New York Corporate & Securities practice. “Expanding our life sciences capabilities is a strategic priority of the firm. With George’s broad experience in FDA regulatory matters, he will add considerable value to many aspects of our work.”
Mr. O’Brien has assisted a wide range of life sciences companies on FDA regulatory matters, including matters affecting drugs, biologics, medical devices, medical foods, over-the-counter and CBD products. A key part of Mr. O’Brien’s practice is assisting life sciences companies in obtaining marketing approval and clearance of novel FDA-regulated products. In particular, he has considerable experience in helping innovator pharmaceutical and biologics companies at all stages of product development to maximize FDA regulatory exclusivity, including Hatch-Waxman, orphan drug and pediatric exclusivities. In addition, Mr. O’Brien has drafted and filed numerous citizen petitions on behalf of life sciences clients on a wide range of issues, including bioequivalence, labeling and approval requirements for generic drug products, the operation of 180-day exclusivity, therapeutic equivalence issues and new chemical entity exclusivity.
“Understanding and successfully navigating the ever-changing regulatory environment is increasingly important for life sciences companies, whether in product development, patent litigation or across the spectrum of life sciences transactions,” said Mr. O’Brien. “Merging my years of experience with Mayer Brown’s robust life sciences practice and geographic reach will further enhance our capabilities to serve the firm’s clients in the global pharmaceuticals, biotech and medical device industries.”
“George’s deep FDA expertise will be a terrific addition to so many aspects of our work for our life sciences and food and beverage clients and adds further depth to our excellent regulatory and transactional capabilities across our international firm,” added Liz Espín Stern, the managing partner of Mayer Brown’s Washington DC office.