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Should patients have a voice in FDA drug approval?

The Center for Ethics in Science and Technology

Wednesday, February 2, 2011 from 5:30 PM to 7:00 PM (PST)

San Diego, United States

Should patients have a voice in FDA drug approval?

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Event Details

Overview: 

Issues regarding the safety and efficacy of new medical products intersect at the table where FDA regulators and companies negotiate approvals.  At present, both parties are constrained: regulators face many “but what if” disincentives, and companies are wary of losing money and development time.  Too often, inaction seems the safest course.


Patient advocates could strengthen this process by serving as mediators.  In his newly published Hastings Center Report article, “A Third Seat at the Table,” Roth proposes a model that would give patient representatives a role in weighing product safety and efficacy concerns.  Speaking for the people who have the most at stake in health care advances, patient advocates can help regulators and companies identify new pathways to nurture innovation, build public trust, cut costs, and address “quality of life” issues. 

Guest speaker:

Duane Roth, CONNECT

Duane Roth is CEO and member of the Board of CONNECT, an organization that has fostered entrepreneurship in the San Diego region since its inception in 1985. He also is Vice Chairman of the citizens' oversight board of the California Institute of Regenerative Medicine (CIRM). He founded Alliance Pharmaceutical Corp., where he is Chairman of the Board of Directors. He has served on the Board of Directors, and executive committees of the Biotechnology Industry Organization, the California Healthcare Institute, and BIOCOM.

Please visit our website for more information

http://www.ethicscenter.net/event/should-patients-have-voice-fda-drug-approval

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When & Where

Community Forum
1875 El Prado
San Diego, 92101

Wednesday, February 2, 2011 from 5:30 PM to 7:00 PM (PST)


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Organizer

The Center for Ethics in Science and Technology

The mission of the Center for Ethics in Science and Technology is to foster science in the public interest by promoting awareness, understanding, and discussion of the ethical implications of new developments in science and technology. To carry out its mission, the Center promotes more informed policy development and ethical decision-making on the part of individuals and institutions through education, outreach, and scholarly forums.

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