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Gail H. Javitt

Counsel
Washington, D.C. 
202.736.8980
202.736.8711 Fax

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GAIL H. JAVITT is Counsel in Sidley’s Food and Drug Regulatory practice. She joins 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 developing policy options to guide the development and use of reproductive technologies and led an initiative to improve oversight of genetic testing quality.

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, and at the Johns Hopkins School of Public Health, and has taught courses including 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.

Publications

Articles include:

  • Javitt G., Katsanis S. H., Scott, J., Hudson, K. “Developing the Blueprint for a Genetic Testing Registry,” Public Health Genomics (epub ahead of print July 2009);
  • Javitt G., Hudson K., “DNA Snoops,” Los Angeles Times, Jan. 27 (Op-Ed) (2009);
  • 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);
  • Katsanis, S.H., Javitt, G., Hudson, K., “A Case Study of Personalized Medicine,” Science 320: 53-54 (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., Hudson, K. “The Right Prescription for Personalized Genetic Medicine,” Personalized Medicine 4(2): 115-118 (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 include:

  • 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).

Reports include:

  • Javitt G, Hudson K., “Public Health at Risk: Failures in Oversight of Genetic Testing Laboratories,” Washington, D.C.: Genetics and Public Policy Center, (2006);
  • Javitt, G., Suthers, K., Hudson, K., “Cloning: A Policy Analysis,” Washington, DC: Genetics and Public Policy Center (2005); and
  • Baruch, S., Javitt, G., Scott, J., Hudson, K. “Reproductive Genetic Testing: Issues and Options for Policymakers,” Washington, DC: Genetics and Public Policy Center (2004).

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