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National Coalition for Quality Colorectal Cancer Screening and Care Testifies Before FDA Advisory Panel on Fospropofol Labeling:
Date:5/16/2008

Coalition Board Member Educates FDA on Concerns that Improper Labeling of

Fospropofol Will Negatively Impact Patient Safety during Colonoscopy

Screenings

ANNAPOLIS, Md., May 16 /PRNewswire/ -- Dr. Stanford Plavin, Board Vice Chairperson of the National Coalition for Quality Colorectal Cancer Screening and Care ("Coalition"), a 501(c) 6 not-for-profit association, testified on May 7th before the U.S. Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory Committee relating to the importance of patient safety when anesthetic agents are administered during colonoscopy screenings.

"I am extremely pleased that the FDA Advisory Committee chose to consider patient access and safety first and foremost in their analysis of fospropofol and how it should be administered," said Dr. Plavin, managing partner of Ambulatory Anesthesia of Atlanta, P.C. "While the recommendations of the FDA Advisory Committee are not binding, it speaks for itself that the Committee members voted nine to one to restrict the use of fospropofol. This agent should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. The practitioner administering fospropofol for sedation/anesthesia should have the education and training to identify and manage the airway and cardiovascular changes which occur in a patient who enters a state of general anesthesia, as well as the ability to assist in the management of complications."

"A primary goal of the Coalition is to promote safe sedation for colorectal cancer screening," notes Steven J. Morris, MD JD FACP FACG, Coalition Board Chairperson and CEO of Atlanta Gastroenterology Associates, LLC. "The Coalition is dedicated to ensure that patient care and quality is never compromised. Minimizing appropriate clinical oversight in an attempt to save dollars, at the expense of patient safety or at the cost of human lives, is unacceptable."

The Coalition, comprised of gastroenterologists, surgeons, primary care physicians, oncologists, anesthesiologists, patient advocacy groups, and concerned individuals, supports a sustained effort of advocacy, collaboration, research, and education geared toward key stakeholders, including the public.

Dr. Morris notes, "Access to optimal agents for sedation delivered by appropriately trained professionals is critical in order to encourage patients to undergo screening colonoscopies. We applaud the recommendations of the FDA Advisory Committee and look forward to their formal adoption by the FDA."

To learn more about the activities of the Coalition, visit http://www.preventingcolorectalcancer.org. You can contact the Coalition at (866) 461-9296 (toll free) or via email to info@preventingcolorectalcancer.org.

Headquartered in Annapolis, Maryland, the National Coalition for Quality Colorectal Cancer Screening & Care (http://www.preventingcolorectalcancer.org) has been established to preserve the tradition of safe, comfortable and quality-based medicine. The mission of the Coalition is to educate the public and key stakeholders about the opportunities to reduce the incidence of colorectal cancer through maintaining screening and care options for patients.


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SOURCE National Coalition for Quality Colorectal Cancer Screening& Care
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