Morgan Lewis today announced that a team of five well-recognized FDA regulatory lawyers have joined the firm as partners in its FDA and Healthcare Practice, resident in Washington, D.C. Led by Gary Yingling—one of the most senior, well-respected FDA lawyers in the country—the team includes former senior USDA attorney Robert Hibbert, as well as Ann Begley, Anthony Pavel, and Rebecca Dandeker. Having worked together for many years, the group serves both domestic and European companies that operate in every sector of the FDA- and USDA-regulated industries.
“Over the past three years, our practice has grown substantially, as colleagues have joined us whose experience includes FDA regulatory issues, healthcare, public policy matters, as well as federal drug pricing programs and government contracts,” noted Kathy Sanzo, leader of the firm’s FDA and Healthcare practice. “The arrival of this group signals our commitment to continuing to meet the increasingly complex needs of the life sciences industry-and in particular the food segment of that industry—as ours becomes one of the largest FDA regulatory practices in the U.S. legal market.”
“Morgan Lewis has long been a leader in FDA and Healthcare law, and we are pleased to be joining this thriving regulatory practice,” said Yingling. “We are confident that our clients will benefit from Morgan Lewis’ innovative and collaborative approach to representation.”
With more than 200 lawyers, scientists and other technical specialists who focus on the life sciences and healthcare industries, Morgan Lewis has one of the most comprehensive practices of any U.S. law firm.
“As class action litigation involving food claims and food safety are expected to grow rapidly, and as the market continues to see an increase in life sciences transactional activity, this team will be an asset to our clients and the firm,” added Stephen Paul Mahinka, Chair of the Life Sciences & Healthcare Interdisciplinary Group at Morgan Lewis.
Gary Yingling worked at the FDA in the general counsel’s office in the early 1970s, as Director of the Food and Drug Law Institute for several years, and then entered private practice in the 1980s. He is a frequent speaker on FDA regulatory issues, who has been recognized by Chambers USA as “one of the most experienced practitioners in the market, with exposure to numerous facets of FDA regulatory law.”
Robert Hibbert is a senior, well-known USDA and food lawyer with significant experience in USDA (meat and poultry) law. He had a senior position at the Food Safety Inspection Service at USDA for many years before entering private practice.
Ann Begley, who has a nursing background, has spent almost her entire career practicing with this group. She has significant experience with homeopathic and drug clinical trial issues and represents the Homeopathic Pharmacopeia and Consortium of Institutional Review Boards. In addition to her FDA practice, she also counsels on FTC and NAD advertising issues and would be an additional asset to the Advertising, Consumer Protection and Privacy Initiative of the Firm.
Anthony Pavel serves as general counsel for the Enzyme Technical Association and has substantial experience with food industry issues. He is a frequent speaker on regulatory issues affecting the food industry and advises firms on food safety, ingredient approval and marketing matters. Mr. Pavel also a counsels medical device firms on a broad range of regulatory matters, and is a recognized expert on e-health and telemedicine issues.
Rebecca Dandeker is primarily involved in advising pharmaceutical companies on product approval issues, including life cycle management issues. She currently advises both pioneer and generic drug companies on regulatory issues. Her experience is particularly relevant in view of the expansion of biosimilar (follow-on biologics/biotechnology) products and the recent expansion of pioneer pharma companies into the generic drug industry.
