Community Advocacy

• Research!America
• Digestive Disease National Coalition (DDNC)
• National Health Council (NHC)
• National Coalition of Autoimmune Patient Groups (NCAPG)
• Alliance for a Stronger FDA
• International Society for the Study of Celiac Disease (ISSCD)

July 2020

• Beyond Celiac along with AARDA, HIV+Hepatitis Policy Institute and +100 other organizations sent a letter to CMS opposing a proposed rule that will change how pharmaceutical companies approach Medicaid Best Price and Average Manufacturer Price reporting requirements. This policy shift puts at risk the life-line to drug affordability that patients need, especially those suffering from serious illnesses, chronic conditions, and disabilities including 50 million patients with an autoimmune disease. This comes at a time when COVID-19 is eroding jobs, personal finances, and overall health for millions of families and signals another troubling trend that puts patients’ health and wellbeing at risk. It’s time to put the patient first and preserve critical access to medicines. Read the letter. 
   

June 2020

• Beyond Celiac signs a letter to the FDA written by Gluten-Free Watchdog regarding their temporary policy regarding certain food labeling requirements during the COVID-19 public health emergency. It urges the FDA to make a minor modification to the Temporary Guidance to include a specific reference to the Gluten-Free Labeling Rule that clarifies how manufacturers should proceed in making substitutions involving gluten. Read the letter. 
• Salvatore Alesci, MD, PhD Beyond Celiac Chief Scientist and Strategy Officer, presented to the NIH Autoimmune Diseases Coordinating Committee, whose purpose is to facilitate coordination of research across the National Institutes of Health (NIH), federal agencies, professional societies, and patient and advocacy organizations with an interest in autoimmune diseases. This committee only meets 1-2 times a year, so it speaks volumes about the work the Beyond Celiac has been doing that celiac disease was the primary focus of this meeting, even amidst a global pandemic. In addition to his presentation, noted colleagues—including former board member Ciaran Kelly, MD and 2019 Beyond Celiac Symposium panelist Joe Murray, MD—also gave the committee a deep dive on celiac disease and its impact on our community. It’s no secret that NIH funding for celiac disease is not where it should be, and together with you, we at Beyond Celiac are accelerating treatments and a cure. In addition to our Go Beyond Celiac patient database, which has an enrollment of nearly 6,000 members of our community, we have funded more than $600,000 in research directly, and by doing so, we are actually attracting greater attention from the NIH for our work. This cycle will hopefully be self-perpetuating, with funding begetting more funding for research. Regardless, we will continue doing the work for as long as it takes to ensure that our community can eat without fear and live life to the fullest.
• Beyond Celiac has joined other patient advocacy organizations in requesting emergency supplemental funding for the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to support research related to Covid-19. While Congress has provided supplemental funding to the National Institutes of Health (NIH), including several of its institutes and centers, to respond to this public health emergency, NIDDK has not yet received any such emergency funding. It is imperative to learn how the unique aspects of how the virus presents and progresses in patients with the comorbid conditions that NIDDK is charged with studying to help clinicians treat patients with COVID-19, as well as to prepare for the next wave of this virus. This letter addressed to leaders in the US Senate and House of Representatives expresses our concern that COVID-19 and its health effects will not be truly understood and addressed without appropriating funds to NIDDK to conduct COVID-19 related research in scientific areas within its mission. Without additional funding, NIDDK may be forced to divert funds from its existing priorities as this national health emergency commands attention. Read the letter. 

May 2020

Beyond Celiac Signs Letter Supporting Research Funding (Research Protection for Nonprofits). In a letter to Leaders McConnell and Schumer and Senators Thune and Durbin, Beyond Celiac joined over 120 nonprofit organizations to protect funding for research for nonprofits during this pandemic. These national organizations expressed their appreciation for the Congressional response to the COVID-19 pandemic and its economic impact. The signatories to the letter wrote to encourage Congress to provide at least $2 billion in bridge funding in future Congressional COVID-19 relief packages to assure the stalled research supported by non-profit organizations, voluntary health associations, science societies, and foundations, can resume once researchers return to their labs. 

Expressing deep concern about the economic consequences that the Covid-19 pandemic will have on America’s research pipeline, this appeal notes that the non-profit and voluntary health organization research community is a critical part of America’s drug research and development pipeline. It is the fourth largest contributor for U.S. medical and health research and development expenditures, and funds thousands of early and mid-career scientists and researchers each year. Collectively this sector of the research community invests at least $6-7 billion each year to advance biomedical research and grants from the National Institutes of Health or other federal research agencies. There is grave concern that a decrease in research funding from this community will force many researchers to abandon important research projects, including disease specific research, and will result in a gap of needed researchers for years to come.

When the House of Representatives returns to Washington DC, this letter will go out to House leadership, as well.  

April 2020

Beyond Celiac signs letter: Friends of NIDDK Letter to Congress on Supplemental Funding for NIDDK During COVID-19.

March 2020

As part of our advocacy, we signed on to a letter going to Congress asking for continuing and increased (5% plus inflation) support for the critical and highly successful defense health research programs funded through the Congressionally Directed Medical Research Programs (CDMRP) at the Department of Defense (DoD). 

While many of these DoD programs are directly related to research concerning preparedness and response to global pandemics, others fund research from a wide range of medical conditions and health challenges.  This includes autoimmune diseases.

On Sunday, March 1, members of the Beyond Celiac team spent their morning at Children’s Hospital of Philadelphia’s annual Celiac Education Day. 

There, they informed attendees about legislation, shared information on the importance of the gluten-free diet, how to correctly read food labels, tips for eating out, and updates on our research efforts to patients with celiac disease and their caretakers. Visitors were also able to sample a number of gluten-free treats, learn about the gluten-free lifestyle, and meet CHOP healthcare leaders specialized in the treatment of celiac disease.

On December 11, 2019, Senator Richard Blumenthal [D-CT] introduced S.3021, to the Senate floor. This bill is meant to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes. It will also be known as the Gluten in Medicine Disclosure Act of 2019.

On April 3, 2019, Representative Tim Ryan [D-OH] introduced H.R. 2074, the Gluten in Medicine Disclosure Act of 2019 to the to the House of Energy and Commerce Committee’s Subcommittee on Health. It uses the same language as the Senate version of the bill.

If passed, these bills would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications.

Early in our history, Beyond Celiac stepped into the field of advocacy when we learned that there were not any celiac disease organizations actively involved in addressing the risk of potential gluten exposure through medications.

Beyond Celiac has expanded its advocacy initiatives and has focused on advocating for access to high quality healthcare, along with gluten-free food and drug safety standards by providing training and resources to the foodservice industry and regulatory agencies. 

Our current advocacy focuses include getting the Gluten in Medications bills passed as well as maximizing investment of public funds in research and public policy supporting these desired outcomes.

Below are some of our advocacy highlights:

Addressing Challenges for U.S. Gluten-Free College Students

In 2012, Beyond Celiac continued its work in the college and university setting by surveying nearly 1,000 U.S. gluten-free college students to strengthen our ability to advocate for improved training for college foodservice operator. This survey revealed a continued and pervasive lack of awareness and accommodation for students with gluten-related disorders.

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Involvement with the Digestive Disease National Coalition (DDNC)

Beyond Celiac is a member of the Digestive Disease National Coalition (DDNC), an advocacy organization focused on improving public policy related to digestive diseases and increasing public awareness of and government funding for digestive diseases.

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Participation in the U.S. Food and Drug Administration (FDA) Patient Representative Program

In 2012, Alice Bast, Beyond Celiac President and CEO and Kristin Voorhees, MA, Beyond Celiac Director of Healthcare Initiatives were chosen to serve as FDA Patient Representatives for celiac disease as part of FDA’s program to ensure that patients have a voice in its regulatory decision-making.

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Drug Information Association (DIA) Participation

Kristin Voorhees, MA, Beyond Celiac Director of Healthcare Initiatives was a 2013 Patient Advocate Fellow for the Drug Information Association (DIA).

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Education of Pharmacists and the Labeling of Gluten in Medications

Beyond Celiac works with the FDA and private organizations and corporations to meet our shared goal: safe pharmaceutical care for those who must maintain a medically necessary gluten-free diet.

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Gluten-Free Food Labeling

Beyond Celiac actively worked to secure regulations that define the requirements for food companies manufacturing packaged products that make a gluten-free label claim.

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Working with Celiac Centers of Excellence: Providing Data to Advance a Better Understanding of Celiac Disease

Beyond Celiac collects information and data from patients and their families about their concerns, attitudes and health outcomes, partnering with experts to advance a better understanding of the disease and how to manage it.

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Speaking Engagements and Industry Presentations

Beyond Celiac influences decision makers that impact all aspects of life to advance the interests of the celiac disease community.

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Beyond Celiac in National Media

Beyond Celiac engages in press outreach and fields press inquiries from national media and industry reporters looking for expert input.

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Ongoing Advocacy for Safe Medications

• From 2011-2014, Beyond Celiac spearheaded a study with a grant from the FDA demonstrating that gluten in medications is a significant issue for the celiac disease community that needs to be addressed, and launched the GREAT Pharmacists training program. Read more about the study here.
• In late 2017, the FDA released draft guidelines for labeling gluten in medications. While the efforts were a start, the action was not enough. The FDA accepted comments about the guidelines through February 12, 2018. Beyond Celiac officially responded and worked with the celiac disease community to get the most responses we could on the draft. Click here to read the letter we wrote to the FDA regarding their draft for our community members to send. We asked our community to send it in response during the open comment period. Over 800 comments were received.
• On April 3, 2019, Representative Tim Ryan introduced the Gluten in Medicine Disclosure Act of 2019 to the congressional floor. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications. (Learn how to help get this bill passed here.)
• On December 11, 2019, Senator Richard Blumenthal introduced S.3021, to the Senate floor. This bill is meant to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes. It will also be known as the Gluten in Medicine Disclosure Act of 2019 and uses the same language as H.R. 2074, the bill Representative Tim Ryan [D-OH] introduced to the House in April. (Learn how to help get this bill passed here.)

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