Hogan Lovells announces David Fox as new Practice Area Leader for Pharmaceuticals and Biotechnology

Janice Hogan, the Practice Group Leader for the firm's Global Regulatory & IP practice, said, "I am thrilled that David will be assuming this role to continue the success of our market-leading practice. Our clients know that having someone of his caliber and experience will ensure their business goals are met and top-notch service continues to be delivered.”

Fox is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances. He advises management teams, from start-ups to the largest global pharmaceutical and biotechnology companies, on matters before the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA). In 2025, Fox received the Food and Drug Law Institute (FDLI) Distinguished Service and Leadership award in recognition of his career-long commitment to the food and drug law legal community.

Known for his collaborative approach to complex regulatory issues, Fox has successfully resolved numerous disputes between sponsors and staff at FDA on products that raise novel regulatory issues. As a former senior lawyer for FDA and throughout his career in private practice, Fox has been deeply immersed in the regulatory side of the Hatch-Waxman Act, including pioneer-generic disputes and numerous cases of first impression involving exclusivity issues, Orange Book listings, and patent term extensions.

Fox commented, “It is an exciting time to be practicing in the pharmaceutical and biotechnology space. As the global regulatory environment continues to develop and shift, I am honored to be leading this world-renowned practice.”

“Our group has a long history of hiring exceptional lawyers from the FDA, including David Horowitz, Meredith Manning, Heidi Gertner, Rob Church, Mike Druckman, Lowell Zeta (now serving at FDA), and most recently former FDA Chief of Staff Elizabeth Jungman, as well as cultivating our strong internal talent, with recent promotions of Komal Nigam and Sally Gu,” Fox said. “Together, we have built a practice with deep regulatory expertise coupled with a strong understanding of our pharmaceutical clients’ business needs.”