Legislative & Regulatory News

Updates about what is happening on the legislative and regulatory level – news events that affect your digestive health.

Proposed Fiscal Year 2009 U.S. Budget – Health Budgets Hard Hit

Update: NIH Budget Increases Adopted by Senate

WASHINGTON, DC (March 13, 2008) The Senate voted 95 to 4 in favor of adopting the “Specter/Harkin” amendment to the Senate’s fiscal year (FY) 2009 budget resolution. This amendment authorizes an additional $2.1 billion for the National Institutes of Health (NIH) in FY 2009, bringing the agency's total potential funding level up to $32.2 billion.

Many thanks to those of you that responded to the Action Alert that we sent to you by urging your Senators to support the amendment. This is an important first step to increasing funding for NIH in FY 2009. The budget process is not yet over.

For more information, please see the interesting floor statement by Senator Arlen Specter (R-PA) located here: Go»

President's Fiscal Year 2009 U.S. Budget Proposal 

WASHINGTON, DC (January 2008) The second session of the 110^th U.S. Congress convened in January 2008 with lawmakers receiving President Bush’s State of the Union Address on January 28^th. The following week the president sent his final budget proposal (for fiscal year 2009) to Capitol Hill. The $3 trillion plan calls for historic increases in defense and homeland security spending and significant cuts in domestic discretionary programs. Among the agencies hardest hit was the Department of Health and Human Services. 

The House and Senate budget committees have initiated hearings with cabinet officials on the White House plan and will soon begin the process of drafting their own budget for fiscal year (FY) 2009. This non-binding budget resolution will serve as a blueprint for future legislative action this year on appropriations and revenue measures.

Some highlights of the President’s budget proposal include:

National Institutes of Health

$29.307 billion for the National Institutes of Health (NIH), the same level of funding as FY 2008.

• $1.858 billion for the National Institute of Diabetes and Digestive and Kidney Diseases at NIH, an increase of $2 million over FY 2008.
  • $428.7 million for the Division of Digestive Diseases and Nutrition (DDN) at NIDDK, a decrease of $500 thousand dollars from FY 2008.
• $1.057 billion for the Office of the Director at NIH, a decrease of $52 million over FY 2008.
  • $41.919 million for the Office of Research on Women’s Health at NIH, the same level of funding as FY 2008. 

Food and Drug Administration

$2.4 billion for the Food and Drug Administration (FDA), not including user fees, an increase of $130 million over FY 2008.

• $739 million for the Human Drug Program at FDA, an increase of $58 million over FY 2008.

Centers for Disease Control and Prevention

$5.691 billion for the Centers for Disease Control and Prevention (CDC), a decrease of $433 million from FY 2008.

NIH Invites Public Comment on Long-Range Research Plan for Digestive Diseases

BETHESDA, MD (February 8, 2008) On July 26, 2005 the 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:

1. To conduct an overview of the state of the science in digestive diseases research, and
2. 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. 

A draft version of the research plan recommendations was made available for public comment; the deaddline was Mar Whether or not you choose to comment, we think you will find this a fascinating document and an important step forward toward improving digestive health.

NIH Announcement

NIH invitation for public comments: Click here 
PDF version of draft research plan: (PDF-4MB)
508 compliant HTML version of draft research plan: (HTML)  

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 a draft of the Conference Statement at this NIH web page - Go ».

 

Proposals for 2008 FDA Budget 

WASHINGTON, DC (July 20, 2007) – Both the U.S. House and Senate Appropriations committees completed their versions of the fiscal year (FY) 2008 Agriculture, Rural Development, Food and Drug Administration (FDA) Appropriations bill on Thursday, July 19, 2007. The bills call for funding increases and reflect a new congressional approach aimed at strengthening the FDA. If adopted, this represents a positive step toward restoring some of the needed resources to the agency.

WASHINGTON, DC (July 17, 2007) – Earlier today the Senate Agriculture Appropriations Subcommittee convened to markup its fiscal year (FY) 2008 Agriculture, Rural Development, Food and Drug Administration (FDA) Appropriations bill. Patient organizations, like the International Foundation for Functional Gastrointestinal Disorders (IFFGD), which have encouraged more support of FDA, have been awaiting the funding amount that would be provided for FDA within this appropriations bill. Fortunately for the patient community, the Subcommittee’s Chairman, Senator Herb Kohl (D-WI), and Ranking Member, Senator Robert Bennett (R-UT), have been two of the FDA’s staunchest supporters.

The Subcommittee proposed providing FDA with $1.76 billion in budget authority (not including user fees) in FY 2008. This amount would fund FDA at a level $186 million (11%) above FY 2007 and $120 million (7.6%) more than the President’s FY 2008 budget request.  The proposed bill represents a significant increase to the FDA’s budget. The House of Representative’s FY 2008 Agriculture, Rural Development, FDA Appropriations bill, that was marked-up by the House Agriculture Appropriations Subcommittee last Thursday, currently provides $1.7 billion for FDA. 

This budget proposal represents an important step to increase the FDA’s budget. Declining funding in past years for the FDA hinders their ability to protect the food supply, and efficiently consider approval and provide access to safe new pharmaceuticals. Recent concerns with imported foods have further illustrated the need for substantially more resources to support FDA’s efforts to protect against unsafe imports. The Subcommittee’s action today will help begin to address this shortcoming by adding $48.4 million in new funding for FDA’s food safety programs.

Furthermore, during the past six years, applications for generic drugs have increased by 158% at FDA. Under the Subcommittee’s proposed funding levels, support for FDA’s generic drug approval programs would be increased by $7.5 million. The Subcommittee also voiced support for new drug development and recommended bolstering FDA’s drug safety programs by $16.2 million. Of note, the Subcommittee announced that the funding was a symbol of a new commitment to FDA.