Lance L. Shea M.S., J.D.

Experience

• 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 present).
• 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a drug company in the development of a citizen petition to the FDA requesting that a competitor’s product be ordered withdrawn from the market because it was never appropriately approved for marketing.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.

Speaking and Teaching

Lance presents at numerous conferences and webcasts on developing scientific and medical evidence for FDA legal matters, such as:

• “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) 

Lance teaches his causal inference methods for developing product performance evidence in graduate curricula at the University of Maryland School of Pharmacy. He has taught science evidence courses at the University of Maryland Francis King Carey School of Law.

Memberships

• Food and Drug Law Institute 
  • Medical Products Committee (2021 and 2022)
  • Several prior committees
• 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