Our Contributions to FDA and Other Regulatory Agencies

As part of our continual presence in Washington, DC, and around the United States, whenever appropriate IFFGD offers testimony to the U.S. Food and Drug Administration (FDA) and other regulatory agencies. Through either written or in person statements, we share the perspective of functional gastrointestinal (GI) and motility disorder patients. We urge consideration of the patient perspective in regulatory decisions and encourage additional resources to help meet their needs.

July 15, 2015

On June 29, 2015, William Norton presented written comments to the Public Docket on behalf of IFFGD members in regard to the FDA Patient-Focused Drug Development meeting on Functional GI Disorders. Read the full comments here.

May 21, 2015

IFFGD provided oral comments to the FDA at the Functional GI Disorders Patient-Focused Drug Development meeting held on May 11, 2015. Read the full comments here.

May 11, 2015

On May 11, 2015, IFFGD participated in the public meeting on Functional GI Disorders Patient-Focused Drug Development conducted by the FDA to gather patient input on the impact of functional GI disorders on daily life and patient views on currently available therapies to treat the functional GI disorders, such as IBS, gastroparesis, GERD symptoms resistant to standard therapy, and chronic idiopathic constipation. Read the full comments here.

July 16, 2014

IFFGD submitted written comments to the FDA in response to docket number: FDA-2010-D-0503, section VI, subsection D ("Foods") of the FDA’s September 2013 "Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND." Read the full comments here.

October 24, 2013

IFFGD sent written comments to Noridian Administrative Services in response to the decision by Noridian to deny Medicare coverage for the Solesta procedure for the treatment of fecal incontinence in adults who fail conservative therapy. Read the full comments here.

October 25, 2012

IFFGD submitted written testimony in support of irritable bowel syndrome (IBS) to the FDA in response to an October 25, 2012 Prescription Drug User Fee Act Patient-Focused Drug Development Meeting.  Read the full testimony here.

September 12, 2012

IFFGD submitted written testimony to FDA in connection with an October 16, 2012 meeting of the Gastrointestinal Drugs Advisory Committee to consider the new drug application (NDA) 203441 by NPS Pharmaceuticals for the drug with the proposed trade name GATTEX® (teduglutide) for the treatment of adult patients with short bowel syndrome (SBS).  Read the full testimony here.

December 13, 2011

IFFGD submitted written testimony to FDA in connection with a January 11, 2012 meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee to consider the premarket approval of the LINX Reflux Management System for the treatment of gastroesophageal reflux disease (GERD). Read the full testimony here.

October 21, 2011

IFFGD sent written comments to Blue Cross Blue Shield of Michigan regarding their consideration of providing insurance coverage for the wireless motility capsule procedure (SmartPill) in patients with suspected gastrointestinal motility disorders. Read the full comments here.

December 2, 2010

IFFGD provided oral testimony to FDA at a meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee to consider the premarket approval of Solesta from Oceana Therapeutics, Inc. Read the full testimony here.

April 23, 2002

IFFGD presented oral testimony to FDA at the Gastrointestinal Drugs Advisory Committee regarding risk management for (NDA)21-107, LOTRONEX (alosetron), produced by GlaxoSmithKline. Read the full testimony here.

November 9, 2000

IFFGD submitted written comments to the FDA in connection with a November 9, 2000 meeting of the FDA Gastrointestinal Drugs Advisory Committee to discuss Lotronex.Read the comments here.

June 27, 2000

IFFGD presented oral testimony to FDA at the Gastrointestinal Drugs Advisory Committee regarding (NDA)21-107, LOTRONEX (alosetron). Read the full testimony here. 

June 26, 2000

IFFGD provided oral testimony to FDA at the Gastrointestinal Drugs Advisory Committee regarding (NDA) 21-200, Zelnorm/Zelmac (tegaserod), produced by Novartis Pharmaceuticals Corporation. Read the full testimony here. 

About IFFGD
Leadership
Nancy J. Norton, IFFGD President
Advisory Board
Board of Directors
Editorial Board Members
Our Mission
Awareness Activities & Accomplishments
Public Education & Awareness
Professional Education & Awareness
Year in Review
-2014
-2012/2013
Advocacy Activities
Legislative Successes
FGIMD Act (Functional Gastrointestinal and Motility Disorders Research Enhancement Act)
Congressional Testimony
FISCAL YEAR 2016
FISCAL YEAR 2013
FISCAL YEAR 2012
FISCAL YEAR 2010
FISCAL YEAR 2009
FISCAL YEAR 2008
FISCAL YEAR 2007
FISCAL YEAR 2006
FISCAL YEAR 2005
FISCAL YEAR 2004
FISCAL YEAR 2003
FDA and Other Testimony
Written Comments to FDA June 29, 2015
Oral Comments to FDA May 11, 2015
Comments to FDA July 16th, 2014
Written Comments to Noridian October 24, 2013
Testimony to FDA October 25, 2012
Testimony to FDA September 12, 2012
Testimony to FDA December 13, 2011
Testimony to FDA December 2, 2010
Testimony to FDA April 23, 2002
Comments to FDA November 9, 2000
Testimony to FDA June 27, 2000
Testimony to FDA June 26, 2000
Capital Hill Advocacy Day
Research
IFFGD Research Awards
IFFGD Symposium reports
2013 Professional Symposium
10th Symposium Report
10th Symposium Audio Recordings
More from the 10th Symposium on FGIDs
2011 Professional Symposium
9th Symposium Report
2009 Professional Symposium
2007 Professional Symposium
7th Symposium Report
2005 Professional Symposium
6th Symposium Report
2003 Professional Symposium
5th Symposium Report
2002 Conference - Advancing the Treatment of Incontinence
Funding
Corporate Support
Our Research Funding Needs
IFFGD Standards for Collaboration
Industry Council
Supporters
Code of Ethics
Contact Us
Media Contact
Donation

Advocacy Effort

capital hill day s

Involvement in Shaping National Health Care Policy

IFFGD is a voice on Capital Hill working with the digestive health community.

Advocacy Activities, Legislative & Regulatory

Legislative Successes

Congressional Testimony