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Gail H. Javitt


GAIL H. JAVITT is counsel in Sidley’s Food and Drug Regulatory practice, where she focuses on FDA regulation of medical devices, biological products, and pharmaceuticals.

Ms. Javitt advises clients on FDA regulatory, safety, and promotional issues involving in vitro diagnostic and other medical devices, drugs, and biological products. She also counsels on regulation of clinical laboratories under the Clinical Laboratory Improvement Amendment (CLIA), and on federal regulation of clinical trials.

Ms. Javitt joined Sidley from her post as the Law and Policy Director at the Genetics and Public Policy Center, at Johns Hopkins University. At the Center she was responsible for initiatives related to reproductive and other genetic technologies.

Ms. Javitt currently serves as a Research Scholar in the Berman Institute of Bioethics at Johns Hopkins University. She has also served as adjunct professor of law at the Georgetown University Law Center, University of Maryland School of Law, and American University’s Washington College of Law, and has taught Genetics and Law and Food and Drug Law. She was a Greenwall Fellow in Bioethics and Health Policy at Johns Hopkins and Georgetown Universities. Prior to her academic career, she was an associate at a Washington, D.C. law firm where she specialized in FDA regulatory issues. She served as law clerk to the Honorable Gary L. Taylor, U.S. District Court, Central District of California.

She has written extensively on a variety of issues at the intersection of law, science, and policy including direct-to-consumer marketing of genetic testing and FDA regulation of biotechnology.

She holds the Juris Doctor (J.D.), cum laude, from Harvard Law School, a Masters of Public Health (M.P.H.) from the Johns Hopkins University and a B.A., magna cum laude, Phi Beta Kappa, from Columbia College.

Selected Publications

  • Javitt G., Carner K., “Must FDA Engage in Rulemaking to Regulate Laboratory-developed Tests?,” FDLI’s Food and Drug Policy Forum (2011);
  • Javitt G., “Why Not Take All of Me? Reflections on the Immortal Life of Henrietta Lacks and the Status of Participants in Research Using Human Specimens,” Minn. J. Law Sci. Tech 11:713-55 (2010);
  • Javitt, G. “Which Way for Genetic Test Regulation? Assign Regulation Appropriate to the Level of Risk,” Nature 466:817 (2010);
  • Javitt G., “Sometimes I Feel Like a Motherless Child: Maryland’s High Court Confronts New Reproductive Realities,” Maryland Bar Journal XLI: 40-45 (2008);
  • Kaufman, D.J., Katsanis, S.H., Javitt, G.H, Murphy, J.A., Scott, J.A., Hudson, K.L. “Carrier Screening for Cystic Fibrosis in US Genetic Testing Laboratories: A Survey of Laboratory Directors,” Clinical Genetics 74: 367-373 (2008);
  • Javitt, G., Berkowitz D., Gostin, L. “Assessing Mandatory HPV Vaccination: Who Should Call the Shots?,” Journal of Law, Medicine, and Ethics 36: 384-395 (2007);
  • Javitt, G. “In Search of a Coherent Framework: Options for FDA Oversight of Genetic Tests,” Food and Drug Law Journal 62: 617-652 (2007);
  • Hudson, K., Javitt, G., Burke, W., Byers P. “ASHG Statement on Direct-to-Consumer Genetic Testing in the United States,” The American Journal of Human Genetics 81: 635–637 (2007);
  • Javitt, G., “Old Legacies and New Paradigms: Confusing ‘Research’ and ‘Treatment’ and its Consequences in Responding to Emergent Health Threats,” Journal of Health Law & Policy 8: 38-70 (2005); and
  • Javitt, G., Hudson, K., Stanley, E., “Direct-to-Consumer Genetic Tests, Government Oversight, and the First Amendment: What the Government Can (and Can’t) Do to Protect the Public’s Health,” Oklahoma Law Review 57: 251-302 (2004).

Book Chapters

  • Javitt, G., Scott, J. “Role of Direct-to-Consumer Testing Companies and Services,” in Genomic and Personalized Medicine (2nd Edition) (forthcoming 2012);
  • Javitt G., Prince, A. “ Gene Therapy,” in Innovation, Dual Use, and Security (J.B. Tucker, ed.) (2012);
  • Hogarth, S., Javitt, G., Melzer, D. “The Current Landscape for Direct-to-Consumer Genetic Testing: Ethical, Legal, and Policy Issues,” Annual Review of Genomics and Human Genetics 9: 161-182 (2008);
  • Hudson, K., Baruch, S., Javitt, G. “Genetic Testing of Human Embryos: Ethical Challenges and Policy Choices,” in Expanding Horizons in Bioethics (Arthur Galston, Christiana Peppard editors), Springer, Dordrecht (2005); and
  • Merrill, R., Javitt, G. “Regulation of Gene Therapy by the U.S. Food and Drug Administration,” in Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology (Thomas J. Murray and Maxwell J. Mehlman, eds.), John Wiley & Sons., (2000).

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