Updates about what is happening on the legislative and regulatory level – news events that affect your digestive health.
FDA Reauthorization Act of 2017: What are User Fees and How Have They Helped the FGIMD Community?
(August 23, 2017) Signed into law in August 2017, the FDA Reauthorization Act of 2017 (HR 2430) reauthorizes user fee programs of the US Food and Drug Administration (FDA) for prescription drugs, medical devices, generic drugs, and biosimilars for five years. User fees, which are paid to the FDA by manufacturers of drugs and medical devices, help support FDA programs aimed at protecting public health and promoting innovation in the development of medical therapies.
One program supported by user fees is the Patient-Focused Drug Development Initiative which seeks to gather the perspectives of patients on their conditions and available therapies more systematically. This initiative included a series of public meetings hosted at the FDA campus in Bethesda, Maryland for selected disease areas. Over 20 public meetings were held between Fiscal Years 2013 and 2017. For each meeting, a Voice of the Patient report was compiled to summarize the input provided by patients, caregivers, and patient representatives at each meeting.
In May of 2015 functional gastrointestinal and motility disorders were selected to be represented at a public meeting. IFFGD gathered with patients, their family members and friends, medical professionals, and representatives from other nonprofits to present oral comments at the meeting. Click to read IFFGD's comments.
Engaging patients to understand more about their illness experiences and needs is an essential part of the treatment development and approval process. Programs like the FDA Patient-Focused Drug Development Initiative provide an opportunity for regulators and industry to gain a better understanding of those experiences and needs directly from the patient.
House FY 2018 VA Bill Includes Increase for Digestive Diseases Research
(June 20, 2017) Approved by the House Appropriations Committee on June 15th, the fiscal year (FY) 2018 Military Construction and Veterans Affairs (VA) Appropriations bill includes an increase of $7.4 billion in funding over FY 2017. The bill funds veterans' benefits, health care, and medical research programs, and includes the following program increases:
- An increase of $362.5 million over FY 2017 for VA Medical Services
- An increase of $22.8 million over FY 2017 for the VA Medical and Prosthetic Research Program
The VA is one of several federal agencies that funds functional gastrointestinal and motility disorders (FGIMDs) research and patient activities and has contributed greatly to advances in our understanding of these conditions. Find more information on the connection between FGIMDs and military personnel at iffgd.org/gi-issues-and-military-personnel.
NIH Funding Increase Included in Bipartisan Budget Agreement
(May 2, 2017) Following the end of the Continuing Appropriations Resolution (CR) enacted by the President and Congress on April 29th, which temporarily set spending levels for most Federal agencies at their fiscal year (FY) 2016 levels, Congressional leaders reached a bipartisan agreement to set funding priorities for the government through September 2017. Increases in funding for border security and the military and an increase of $2 billion (6.2%) over FY 2016 for the National Institutes of Health (NIH) are included in the budget. This marks the second year in a row that the NIH has received a significant increase after 12 years of flat funding.
The NIH is made up of 27 different institutes and centers focusing on different areas of medical research and discovery. One of these centers, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), supports and conducts basic and applied research into the functional gastrointestinal and motility disorders as well as promotes education of these health issues to the American public. Federal budget increases like this one will allow the NIDDK and other agencies concerned with digestive health to spearhead important research into causes and treatments for these conditions and improve care for all affected.
House Members Encourage Digestive Diseases Research
(April 24, 2017) A Dear Colleague letter was circulated in the US House of Representatives by Congressman Bobby Rush (IL-1) inviting his colleagues to sign on to a letter to the House Labor, Health and Human Services, and Education Appropriations Subcommittee members encouraging the committee to support implementation of the research recommendations of the 2009 National Commission on Digestive Diseases Report. At the request of Congress this report, entitled "Opportunities and Challenges in Digestive Diseases," put forward a 10-year plan for key research priorities within the National Institutes of Health (NIH), cover a broad spectrum of scientific areas of inquiry involved in the natural history and treatment of digestive diseases, including fundamental biology, epidemiology, environmental factors, and genetics.
In his letter the Congressman requested an update on the ongoing implementation of the research plan provided by the Commission Report. The letter received support from five additional Members of Congress:
- Danny Davis (IL-7)
- Linda Sanchez (CA-38)
- Yvette Clarke (IL-9)
- Niki Tsongas (MA-3)
- Jackie Speier (CA-14)
Functional GI & Motility Disorders Research Enhancement Act Reintroduced as HR 1187
(March 13, 2017) Last month Congressman F. James Sensenbrenner, Jr. (WI) reintroduced The Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017 as HR 1187. HR 1187 seeks to expand basic and clinical research into functional gastrointestinal and motility disorders (FGIMDs) by implementing the research recommendations of the 2009 National Commission on Digestive Diseases. This budget-neutral legislation grants the National Institutes of Health (NIH) authority to bolster and coordinate research in this area and creates new opportunities for the NIH through the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) to partner with the Department of Defense (DoD) and the Department of Veterans Affairs (VA) to increase research activities.
Following reintroduction of the bill, Congressman Sensenbrenner's office circulated a Dear Colleague letter to invite other House Members of Congress to support the FGIMD community and cosponsor HR 1187.
114th Congress Wrap Up and FY 2017 Funding for Digestive Disorders Research
(December 22, 2016) Final budget decisions for fiscal year (FY) 2017 have been postponed until the next Congress, with Congressional leaders and the President enacting a Continuing Appropriations Resolution (CR) in the meantime, which will set spending levels for most federal agencies through April 29th, 2017. Under the CR, the Department of Health and Human Services (HHS), the Department of Defense (DoD), and many other agencies will continue to be funded at current levels until the CR expires in April.
However, some immediate funding adjustments that are relevant to the digestive health community include:
- $352 million increase to the National Institutes of Health (NIH) for spending specifically authorized by the 21st Century Cures bill, including:
- $40 million for Precision Medicine
- $10 million for the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative
- $300 million for cancer research and the Cancer Moonshot, and
- $2 million for Regenerative Medicine research
- $20 million for the US Food and Drug Administration (FDA) Innovation Fund, which will support young emerging researchers, precision medicine, and other projects and $500 million for state-sponsored opioid research grants, consistent with amounts authorized by 21st Century Cures.
Looking Ahead to the 115th Congress
(December 19, 2016) When the 114th Congress is replaced by the 115th Congress on January 3rd, 2017 The Functional Gastrointestinal and Motility Disorders Research Enhancement Act will need to be reintroduced and it will need your continued support.
Every two years in January a new Congress begins with new legislation to consider. Bills introduced in the previous Congress but not acted upon or passed can be reintroduced in the new Congress (often with a new number). Then the legislation process starts over again.
The Functional Gastrointestinal and Motility Disorders Research Enhancement Act (HR 2311) was introduced in the House of Representatives in the current Congress where it gained bipartisan support from 12 cosponsors. Support in the 114th Congress for HR 2311 was propelled by thousands of digestive health advocates from across the country who reached out to their House Representatives on behalf of the bill. They helped raise awareness about functional gastrointestinal (GI) and motility disorders and the needs of patients and families whose daily lives are disrupted by these conditions.
Thank you to everyone who has taken action for this critical legislation. Continued outreach to House Members of Congress from constituents like you is needed in order to increase support for the bill in the House and get it passed into law.
Functional digestive disorders are the most common GI conditions in the general population. Estimates vary, but approximately 1 in 4 people or more in the US have one or more of these disorders – men, women, and children. The conditions account for about 40% of GI problems seen by doctors and other healthcare professionals in the US. The Functional Gastrointestinal and Motility Disorders Research Enhancement Act aims to help promote awareness of functional GI and motility disorders, expand critical research, initiate important legislation, and facilitate the development of new treatment options for all those affected.
Members of Congress introduce thousands of bills each year but fewer than 3% have so far been enacted in the 114th Congress. Continued action is needed to ensure that The Functional Gastrointestinal and Motility Disorders Research Enhancement Act is passed.
HR 2311 Recap
Thanks to the efforts of advocates across the country, HR 2311 currently has 12 cosponsors in the US House of Representatives. The bill was originally introduced and sponsored by Congressman F. James Sensenbrenner (WI, 5th District).
Other Representatives who have signed on in support of HR 2311 are:
- Andre Carson (IN, 7th District)
- Zoe Lofgren (CA, 19th District)
- Gwen Moore (WI, 4th District)
- David Young (IA, 3rd District)
- David Loebsack (IA, 2nd District)
- Keith Rothfus (PA, 12th District)
- David Joyce (OH, 14th District)
- Sean Duffy (WI, 7th District)
- Eliot Engel (NY, 16th District)
- Mark Pocan (WI, 2nd District)
- Ron Kind (WI, 3rd District)
- Joyce Beatty (OH, 3rd District)
Cosponsors help HR 2311 and other pieces of legislation introduced in the House become law by acting as champions for legislation they support and helping it move forward through the legislative process.
We appreciate the commitment of these House Congressional leaders to functional GI and motility disorders research and improving the lives of all those affected by a chronic digestive condition and hope to have their continued support in the upcoming Congress.
FY 2017 Veterans Affairs Funding Package Includes Increase for FGIMD Research
(November 10, 2016) This next year will feature a new presidential administration, a different Congress, and hopefully a response to demand for increased action in Washington on pressing issues, including issues of funding for health research. While a federal spending package, which will include funding for fiscal year (FY) 2017 for the US Food and Drug Administration (FDA), agencies within the National Institutes of Health (NIH), and the Department of Defense (DOD), will hopefully be finalized during the lame duck session which will finish off the 114th Congress, one appropriations bill has already been signed into law. The FY 2017 funding package for the Department of Veterans Affairs (VA), Military Construction, and Related Agencies has been finalized and includes an increase in funding for functional gastrointestinal and motility disorders (FGIMDs) research and patient activities.
This funding increase includes:
- An increase of $2.8 billion over FY 2016 for VA Medical Services,
- An increase of $44.63 million over FY 2016 for the VA Medical and Prosthetic Research Program,
- And, support for a guidance from the VA on Gulf War Illness.
We will continue to keep you updated during the next few weeks as the other appropriations bills are signed into law.
Three New Cosponsors for HR 2311
(July 6, 2016) Following Virtual Advocacy Day, the Functional Gastrointestinal and Motility Disorders Research Enhancement Act (HR 2311) received three new cosponsors. House Representatives Eliot Engel (NY-16), Mark Pocan (WI-2), and Ron Kind (WI-3) showed their commitment to improving the lives of all those impacted by a functional gastrointestinal (GI) or motility disorder. We deeply appreciate their efforts in support of functional GI and motility disorders research.
Functional digestive disorders are the most common GI disorders in the general population. Estimates vary, but about 1 in 4 people or more in the US have one of thse disorders - men, women, and children. The conditions account for about 40% of GI problems seen by doctors and therapists in the US. The Functional Gastrointestinal and Motility Disorders Research Enhancement Act will help promote awareness of functional GI and motility disorders, expand critical research, initiate important legislation, and facilitate the development of new treatment options for all those affected.
Is Your House Representative a Cosponsor of HR 2311?
Representatives Engel, Pocan, and Kind join nine other House Congressional leaders in supporting this critical piece of legislation. Cosponsors are important to help HR 2311 become law. There are thousands of bills for Congress to consider every session, but only a few become law. Cosponsors act as champions for the legislation they support and help it move forward through the legislative process.
Have you contacted your House Representative about HR 2311? Read more about this piece of legislation and how you can take action.
Two New Cosponsors for Bill HR 2311
(June 29, 2016) After hearing from their constituents following IFFGD's Virtual Advocacy Day, House Members David Joyce (OH-14) and Sean Duffy (WI-7) signed on to The Functional Gastrointestinal and Motility Disorders Research Enhancement Act (HR 2311). On June 23rd people across the United States reached out to their House Members of Congress through email, phone, and social media on behalf of all those affected by a functional digestive condition. We are grateful to Congressmen Joyce and Duffy for answering the call of their constituents and demonstrating their commitment to improving the lives of all those impacted by a functional GI or motility disorder.
FUNDING FOR DIGESTIVE CONDITIONS INCLUDED IN PRESIDENT'S FY 2017 BUDGET REQUEST
(February 9, 2016) Today the White House issued the President’s Budget Request for fiscal year (FY) 2017. Highlights of the proposal included:
- $33.136 billion for the National Institutes of Health (NIH), an increase of $825 million over FY 2016
- $1.966 billion for the NIH, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), level funding with FY 2016
- $14.025 million for the CDC Health Promotion Initiatives, which includes public health awareness related to digestive diseases
LOOKING AHEAD TO THE 114TH CONGRESS: UPDATE ON THE FUNCTIONAL GI & MOTILITY DISORDERS RESEARCH ENHANCEMENT ACT
(May 13, 2015) The Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2015 (HR 2311) was reintroduced in the US House of Representatives on May 13, 2015 by Rep. F. James Sensenbrenner (WI-5) and it needs your continued support.
The 114th Congress began January 3, 2015. Every 2 years in January a new Congress starts over with new legislation to consider. Bills not acted on in the previous Congress can be reintroduced in the new Congress (often with a new number), and the legislative process will start again. More here
FUNDING FOR DIGESTIVE CONDITIONS INCLUDED IN PRESIDENT'S FY 2016 BUDGET REQUEST
(February 27, 2015) Earlier this month the White House issued the President's Budget Request (PBR) to the newly installed 114th Congress for fiscal year (FY) 2016. Highlights of the proposal included:
- An increase over FY 2015 of 3.2% in funding for the National Institutes of Health (NIH) and 2.2% for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with specific language relating to digestive disorders, rare diseases, and the gut microbiome.
- A commitment to pediatric research in the NIH in the amount of $3.6 billion.
- A 8.6% increase for the US Food and Drug Administration (FDA) over FY 2015.
- An increase of 10 in the number of funded research projects for the Gulf War Illness research program.
- Support for the Precision Medicine Initiative (a new model that takes into account individual differences in genetics, environments, and lifestyles when treating disease) through the NIH.
THE STATE OF RESEARCH AT NIH & NIDDK
(October 2, 2014) In inflation adjusted dollars, National Institutes of Health (NIH) appropriations are approximately at the same level as 15 years ago. NIDDK is the National Institute for Diabetes and Digestive and Kidney Diseases, one of 27 NIH Institutes and Centers. The NIDDK conducts and supports basic and applied research.
The tremendous momentum gained from the NIH doubling from 1998 to 2003 has been eliminated.
These policy decisions are causing down-sizing or closure of research programs in the U.S., discouraging young people from choosing to enter the long and arduous training pathways that are needed in biomedical research. Reductions in U.S. material and human capital investments threatens U.S. pre-eminent leadership in biomedical research.
Ironically, this is happening at a time when rapid advances in medical research and technology offer the promise of improvement in the lives of people suffering from many chronic diseases. Progress in developing better diagnostic and treatment approaches for functional GI and motility disorders has been slow. However, due in part to the substantial efforts made by IFFGD, there is increased awareness of the needs of affected individuals and the burdens of illness imposed by these conditions.
NIDDK-funded investigators are making major contributions in the area of basic science discovery helping better understand these conditions. The current NIDDK portfolio spans a broad range of basic and clinical research projects involving tissue and muscle cells, the enteric nervous system (ENS), and mechanistic studies in GERD, dysphagia, and mechanisms of symptom generation, to name a few. The clinical research portfolio includes multi-center studies in gastroparesis, functional dyspepsia, irritable bowel syndrome (IBS), and Sphincter of Oddi dysfunction, among others.
One of the relatively new areas of interest involves understanding the microbiota that we all have in our digestive systems that are believed to play important roles in health and illness. This area is rapidly moving towards therapeutic approaches to improve digestive diseases.
Another exciting area is stem cell research. Tissue models can now easily be made in the laboratory (enteroids) from small endoscopic biopsies of patients to use for study and to lay the foundation for regenerative medicine approaches.
New technologies are opening up ways to better understand how diet is involved in health and illness. NIDDK has contributed to support that focuses on understanding brain gut connections and visceral pain.
NIDDK devotes substantial effort to educate and inform the public on health issues in digestive diseases and the latest advances that result from NIH research. Extensive online materials for the general public are often developed in partnership with organizations such as IFFGD. The NIDDK continues to support the Bowel Awareness campaign, which was developed with considerable input and assistance from IFFGD, with the aim to provide helpful information to individuals with bowel incontinence.
Despite current economic challenges, NIDDK will continue to bring improvements to people with functional GI and motility disorders due to the dedication of many scientists around the country, continued funding from the NIH, and the important contribution of professional societies, organizations such as IFFGD, and patients who participate in research projects and inspire us all.
BETHESDA, MD (February 20, 2009) The National Commission on Digestive Diseases’ long-range research plan for digestive diseases, entitled Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases, is now available in electronic (PDF) format, and soon will also be available in print format.
On July 26, 2005 the then Director of the National Institutes of Health (NIH), Elias A. Zerhouni, MD, chartered the National Commission on Digestive Diseases. The Commission was charged with two main tasks:
- To conduct an overview of the state of the science in digestive diseases research, and
- To develop a 10-year plan for digestive diseases research.
The NIH Director appointed 16 Commission members, including Nancy Norton from IFFGD. In addition to the 16 appointed members, the Commission included 19 ex officio members from the NIH and other federal government agencies involved in digestive diseases research. The members created “working groups” to address major themes; additional working group members were brought in to contribute their expertise and knowledge of current research related to each working group topic.
The Commission then proceeded to address 12 major themes in a Long-Range Research Plan for Digestive Diseases. They organized the plan by categorizing diseases by common causes (etiology), mechanisms, affected organ systems, and other considerations. Each theme includes an overview, a summary of recent research advances, goals for research, and major challenges and steps to achieve the research goals.
The Commission recognized the need for finding ways to achieve and sustain digestive diseases research and developed goals and recommendations for training, education, and the recruitment of new investigators into the field.
Maryland, Bethesda: NIH State-of-the-Science Conference on Prevention of Fecal and Urinary Incontinence in Adults
The U.S. National Institutes of Health (NIH) conducted an NIH State-of-the-Science Conference on Prevention of Fecal and Urinary Incontinence in Adults on December 10–12, 2007.
We are pleased that the conference resulted in a strong statement by the NIH about the huge unmet need of those who are affected by incontinence.
The conference was convened to assess the available scientific evidence relevant to the following questions:
- What are the prevalence, incidence, and natural history of fecal and urinary incontinence in the community and long-term care settings?
- What is the burden of illness and impact of fecal and urinary incontinence on the individual and society?
- What are the risk factors for fecal and urinary incontinence?
- What can be done to prevent fecal and urinary incontinence?
- What are the strategies to improve the identification of persons at risk and patients who have fecal and urinary incontinence?
- What are the research priorities in reducing the burden of illness in these conditions?
For several years, Nancy Norton and IFFGD vigorously encouraged NIH to convene this conference. Ms. Norton served on the Planning Committee for the conference and was one of 21 speakers who presented information to the independent 15-member conference panel, which drafted a consensus and state of the science report. Ms. Norton spoke on the Impact of Fecal and Urinary Incontinence on Health Consumers, Barriers on Diagnosis and Treatment, A Patient Perspective.
The Panel found that fewer than half of individuals experiencing fecal or urinary incontinence — the inability to control bowel movements or urination, respectively — report their symptoms to healthcare providers without being prompted. The secrecy and distress surrounding these issues erode the quality of life for millions, and hamper scientific understanding and development of prevention and treatment strategies.
Healthcare provider education about incontinence is needed. But, the Panel reported, provider education alone will be insufficient to improve detection, prevention, and treatment. Public policy changes, including appropriate reimbursement, regulation, and management are also needed. Raising public awareness is a priority. To help reduce the stigma associated with these conditions, the panel had the following messages for those experiencing incontinence:
- You are not alone
- Some medical conditions can cause incontinence and can be treated
- Incontinence does not need to be a part of aging
- Lifestyle changes and behavioral interventions can prevent incontinence in many cases
- You should tell your healthcare provider
Though fecal and urinary incontinence can affect men and women at all life stages, both conditions disproportionately affect women, especially those who have given birth, as pelvic muscle injury during childbirth and routine episiotomy are associated with a higher rate of fecal incontinence. For this reason, the panel recommended that episiotomy not be routinely performed during childbirth.
The 15-member conference panel included experts in the fields of geriatrics, nursing, gastroenterology, obstetrics and gynecology, internal medicine, urology, general surgery, oncology, neurosurgery, epidemiology, biostatistics, psychiatry, rehabilitation medicine, environmental health sciences, and healthcare financing, as well as a public representative.
We thank the conference sponsors – the NIH Office of Medical Applications of Research (OMAR) and the National Institute of Diabetes and Digestive and Kidney Diseases, along with other components of the NIH – for making the conference possible.
The text of Ms. Norton’s presentation on The Patient Perspective is available on this IFFGD web page - Go ».
You may access information about the conference, including the Final Conference Statement at this NIH web page - Go ».