I represent clients at the intersection of health science and law, primarily in the drug and medical device industries.
Lance Shea handles FDA regulatory and litigation matters that require development and advocacy of scientific evidence – primarily evidence supporting exclusive marketing life cycles of clients’ innovator drugs (e.g., protecting against approval of generics via inappropriately lax standards, addressing adverse pre-approval issues, and defending against unwarranted allegations of postmarketing safety issues).
Often, these matters involve cutting-edge legal and policy arguments based on interpretation of scientific studies. Additionally, he advises clients on the development of evidence needed to protect marketing exclusivity and market share for medical products – a process that spans entire product life cycles.
Lance's work is focused on keeping clients out of court. The matters he handles usually involve complex scientific evidence and multiple expert witnesses.
University of San Diego School of Law, J.D., magna cum laude (1989)
Arizona State University, M.S. in Health Science (1986)
The University of Arizona, B.S. in Health Science, with distinction (1982)
Bar and Court Admissions
BAR ADMISSIONS
District of Columbia
Experience
Developed a white paper for submission to the European Medicines Agency and drug approval authorities in specific European countries advocating for rigorous approval standards of generic versions of a locally acting, locally applied drug (2025).
Obtained a major revision to the FDA’s product-specific guidance for an innovator drug company’s top selling drug by developing and submitting an evidence-driven “505(q)” citizen petition (2017).*
Obtained a second major revision to the same product-specific guidance by developing another evidence-driven “505(q)” citizen petition (2022).*
Developed and submitted evidence-driven comments on the FDA’s product-specific guidance for an innovator drug company’s peptide dermatologic drug (2022).*
Developed and submitted an evidence-driven “505(q)” citizen petition requesting that the FDA issue a product-specific guidance document recommending certain generic approval standards for an innovator drug company’s complex dermatological drug (2021).*
Represented a drug company in various litigation matters in which evidence of physicochemical composition and performance of a complex drug was at issue (2017 to 2022).*
Represented a drug company in the development of a citizen petition to the FDA requesting that a competitor’s product be ordered withdrawn from the market because it was never appropriately approved for marketing.*
Represented an executive of a drug company in a securities fraud case, in which evidence of product risk was a key issue.*
Represented an international drug company that had received reports of potentially fatal adverse drug events and advised on empaneling a safety advisory committee, assessing a future life cycle strategy based on evidence of the possible drug-event relationships, amending product labeling and preparing litigation defense.*
Represented a cosmetic device manufacturer in the development of an impactful advertising claims strategy by identifying potential strengths and weaknesses in an existing clinical trial, suggesting potential alternative claims and recommending additional studies.*
Represented a drug company required to conduct a post-marketing safety study for a rare adverse event and recommended a novel trial designed to test the role of risk factors that appeared related to the adverse event rather than a study of standard design.*
Represented academic medical centers in evaluating and managing conflicts of interest in clinical trials research.*
Represented drug companies in long-running, nationwide mass torts alleging injury from OTC cough and cold products, prescription analgesic products and prescription colonoscopy preparation products. Often serves in the role of lead science counsel.*
* - Denotes representations handled by Lance prior to joining Foley Hoag.
Honors & Involvement
HONORS
The Best Lawyers in America, Washington, D.C.: FDA Law (2019 to Present)
Chambers USA: Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia; Recognized Practitioner (2016 to 2017)
Martindale-Hubbell: AV Preeminent Washington, D.C. “Super Lawyer” (2014 to 2016)
San Diego Law Review, Editor-in-Chief
INVOLVEMENT
Food and Drug Law Institute: Annual Conference Planning Committee (2026); Medical Products Committee (2021 - 2025); several prior committees, initiatives and publications
Health University of Maryland Francis King Carey School of Law: Adjunct Professor, Scientific Evidence (2014 to 2017)
University of Maryland School of Pharmacy: Affiliate Assistant Professor, Regulatory Science graduate curriculum
Speaking Engagements
"FDA Regulatory Shifts and Compliance in a Changing Landscape," Foley Hoag's Boston Life Sciences Summit (October 2025)
"Exclusivity Explained: Regulatory Protections for Life Science Companies," MassBio’s 2025 General Counsel (September 2025)
“Launch Begins Drug Development,” Foley Hoag Webinar (May 2025)
“Innovator Strategy for Heightened ANDA Approval Standards,” Foley Hoag podcast (January 2025)
"Navigating the Intersection of FDA and CMS Policy: Implications of Post-Election Regulatory Shifts," Foley Hoag Webinar (December 2024)
“Beyond Statistics: Key Principles for All Professions in the Field,” FDLI Clinical Trials Conference (2022)
“Statistics and Data for Regulatory Professionals and Attorneys,” FDA News webcast (2022)
“Essentials of Clinical Trial Science,” FDLI webinar (2021)
“Gene Therapy Past and Present – Approval and Post-Market Challenges,” FDLI Regenerative Medicine Conference (2020)
“Regulatory Challenges of Biologics Across the Globe,” FDLI Annual Conference (2017)
“An Introduction to U.S. Drug Law and Regulation, Conduct of Clinical Trials and Human Subjects Protections,” Patient Organizations Conference (2017)
“Enhancing Patient Centricity: Communication and Involvement,” FDLI Advertising and Promotion Conference (2017)
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