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.

February 15, 2019

On February 15th, 2019 IFFGD thanks the U.S. Social Security Administration (SSA) for the opportunity to provide comments regarding “Consideration of Pain in the Disability Determination Process.” Read the full text here. 

February 5, 2019

On February 5th, 2019 IFFGD thanks the U.S. Department of Health and Human Services (HHS) and the Pain Management Best Practices Inter-Agency Task Force for the opportunity to provide comments regarding the “Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations.” Read the full text here. 

December 13, 2018

On behalf of IFFGD, Ceciel Rooker submitted written comments to the US Department of Defense in connection with a January 10, 2019 meeting of the TRICARE Beneficiary Advisory Panel regarding the Uniform Formulary and, specifically, review of gastrointestinal agents. Read the full text here. 

October 18, 2018

On October 18, 2018, Ceciel Rooker provided the FDA with written comments in connection with a joint meeting of the FDA Gastrointestinal Drugs Advisory Committee and Risk Management Advisory Committee to discuss the reintroduction of Zelnorm. Read the full text here.

October 17, 2018

On October 17, 2018, Ceciel Rooker provided the FDA with written comments in connection with a October 17, 2018 joint meeting of the FDA Gastrointestinal Drugs Advisory Committee to discuss approval of prucalopride. Read the full text here.

September 12, 2017

On September 12, 2017, Ceciel Rooker, IFFGD Executive Director, provided the FDA with the published results of the Gastroparesis in the Community Research Survey Report explaining the burdens and needs of people affected by gastroparesis. Read the full text here.

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. 

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.