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november 5, 2016

On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represented dramatic changes in the fight against HIV and raised a host of legal, clinical, and public health issues. The Petrie Flom Center hosted a panel discussion of these issues with some of the preeminent leaders in the field, which was moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation. Panelists included:

  • Douglas A. Michels, President and CEO, OraSure Technologies, Inc.

  • David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.

  • Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute

  • Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health

  • Mark Barnes, Partner, Ropes Gray, Lecturer in Law, Harvard Law School

Co-sponsored by the Fenway Institute.

Tags

fda   health law policy   hivaids   public health   regulation