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13 APRIL 2018

ALF Attends FDA Meetings in Maryland

The American Liver Foundation’s latest National Patient Advocacy Committee cohort consists of individuals who have been affected by alcohol-related liver disease.  Within weeks of their training at last month’s Advocacy Day, they again went into action as ALF, the American College of Gastroenterology, the American Gastroenterological Association, and the National Institute on Alcohol Abuse and Alcoholism joined with the Federal Food and Drug Administration (FDA) for a two-day workshop at the FDA’s Silver Spring, MD campus on March 26th and 27th.

The workshop provided presentations and discussions on what is known about alcohol associated liver disease and facilitated dialogue among stakeholders on common data elements that need to be included in clinical trials and clinical trial designs.  Attendees included scientists from regulatory, academic, industrial and other healthcare sectors responsible for evaluating the safety and efficacy of drugs intended to treat or prevent alcohol associated liver disease (AALD).

ALF’s Patient Advocates were extremely well received.  So much so, that the workshop organizers added a special panel discussion on the second day of the workshop that consisted of just our NPAC members, Jonathan Martin, ALF’s National Director of Programs, and myself. This provided an excellent opportunity for NPAC members Brian Bourgault, Sheila Rieders and Mike Posivak to share their stories and answer questions.  In addition, Brian presented the patient perspective and how patient advocacy groups can work to support clinical trials.

Brian summarized the feelings of the NPAC members, “I was extremely pleased and honored to give an AALD Patient Profile presentation and participate on the panels.  I learned an immense amount about clinical trials and the challenges the researchers and patients face.  In addition, the American Liver Foundation Panel discussion, represented by ALF Patient Advocates and ALF Leadership where the doctors asked patient specific questions, was very much appreciated.  I only wish we had more time.”

Based on overwhelmingly positive feedback, everyone felt that the addition of the patient voices was very important and that going forward the FDA and NIAAA need to incorporate that voice into the discussion and consideration of new drugs and new treatments.

Tom Nealon
American Liver Foundation

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