Is the Food and Drug Administration Effectively Communicating Risk/Safety Information on Drugs and Devices to Physicians and the Public?
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WASHINGTON, Nov. 26 /PRNewswire-USNewswire/ -- In 2005, FDA banned the use of a device that repairs damaged cells and treats cancer through electromagnetic waves, known as the Pap-Ion Magnetic Inductor (PAP-IMI), because of its apparent connection to patient injuries and death. However, on November 19, 2007 The Seattle Times reported that the PAP-IMI is still in use in at least five states, and that FDA has yet to issue a public statement about the risks linked with the device.
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FDA's task is indeed daunting. A panel of experts will discuss and debate the issue of risk communication at a landmark colloquium, Communicating Risk/Safety Information: How FDA Is Meeting the Challenge, sponsored by the Food and Drug Law Institute (FDLI), Dec. 6, 2007, in Washington, D.C.
This meeting is the third in a series of colloquia sponsored by FDLI. Under its new strategic direction, FDLI is committed to using the colloquium series as a neutral forum to address the legal, regulatory, policy and practical implications of technological innovations affecting the food and drug industry.
As the public becomes more concerned about whether it's safe to take --- or stop taking --- their medications, FDA is making risk communication a top priority. The agency has formed an advisory committee on communication and implementing new Congressional requirements on risk evaluation. This program seeks to clarify what that means for those who must deal with adverse events and contraindications every day.
Colloquium attendees will receive:
-- Results of a study on how FDA handled the antidepressant drug controversy;
-- Analysis of the new risk evaluation and mitigation strategy (REMS) requirements;
-- Tips on developing world-class risk/safety and communications plans;
-- Vital information on FDA's new Risk Communications Advisory Committee;
-- An inside look at FDA's overall risk communications strategy from its Director of Risk Communication, Nancy Ostrove; and
-- Excerpts from FDA's Response to the IOM's Report on Drug Safety.
The expert panel includes:
-- Nancy Ostrove, Director, Risk Communication, FDA;
-- Randall Lutter, Deputy Commissioner for Policy & Planning, FDA;
-- Stuart Pape, Managing Partner, Patton Boggs;
-- Robert Dormer, Partner, Hyman Phelps & McNamara;
-- Grace-Marie Turner, President, Galen Institute;
-- Susan Newberry, Senior Vice President, Director, D.C Healthcare Practice, Ketchum Communications; and
-- Kelly Posner, Associate Professor, Columbia University.
Registration is $295 for FDLI members, $395 for non-members. Attendance is limited, so registrants are strongly urged to sign up early.
To register, visit http://fdli.org or call +1-800-956-6923 or +1-202-371-1420.
Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.
SOURCE Food & Drug Law Institute
