Biostatistics and FDA Regulation: The Convergence of Science and Law

On May 20, 2014, the Food and Drug Law Institute (FDLI), the Drug Information Association (DIA), and the Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center, presented a symposium on“Biostatistics and FDA Regulation: The Convergence of Science and Law.”

The symposium might just as well have been described as the collision of science and law.

The Symposium agenda addressed several cutting-edge issues on statistical evidence in the law, criminal, civil, and regulatory. Names of presenters are hyperlinked to presentations slides that are available.

I. Coleen Klasmeier, of Sidley Austin LLP, introduced and moderated the first section, “Introduction to Statistics and Regulatory Law,” which focused on current biostatistical issues in regulation of drugs, devices, and foods by the Food and Drug Administration (FDA). Qi Jiang, Executive Director of Amgen, Robert T. O’Neill, retired from the FDA, and now Statistical Advisor in CDER, and Jerald S. Schindler, of Merck Research Laboratories, presented.

II. Qi Jiang moderated and introduced the second section on safety issues, and the difficulties presented by meta-analysis and other statistical assessments of safety outcomes in clinical trials and in marketing of drugs and devices. Lee-Jen Wei, of the Harvard School of Public Health, Geoffrey M. Levitt, an Associate General Counsel of Pfizer, Inc., and Janet Wittes, of the Statistics Collaborative, presented.

III. Aaron Katz, of Ropes & Gray LLP, introduced the third section, on “Statistical Disputes in Life Sciences Litigation,” which addressed recent developments in expert witness gatekeeping, the Avandia litigation, and the role of statistics in two recent cases, Matrixx, Inc. v. Siracusano, and United States v. HarkonenAnand Agneshwar, of Arnold & Porter LLP, Lee-Jen Wei, Christina L. Diaz, Assistant General Counsel of GlaxoSmithKline, and Nathan A. Schachtman presented.

IV. Christopher Robertson, a law professor now visiting at Harvard Law School, moderated a talk by Robert O’Neill on “Emerging Issues,” at the FDA.

V. Dr. Wittes moderated a roundtable discussion on “Can We Handle the Truth,” which explored developments in First Amendment and media issues involved in regulation and litigation. Anand Agneshwar, and Freddy A. Jimenez, Assistant General Counsel, Johnson & Johnson, presented.

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