David Fox

David Fox leads the firm’s Pharmaceuticals and Biotechnology Regulatory Practice and 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). David is frequently retained as a strategic advisor on assessing the value of life sciences assets. Known for his collaborative approach to complex regulatory issues, David 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, David 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.

During his FDA tenure, David received the Secretary’s Award of Merit and an FDA Special Citation for his work on the FDA Tobacco Rule. David is a founding member of the Kitalys Institute to support interventions that delay the onset of diseases of aging, and David is on the Advisory Board of the Cancer Support Community. David also serves as pro bono counsel on a variety of programs to improve patient and care-giver welfare.