As the leading celiac disease organization focused on accelerating discovery, development and access to new treatments and a cure, Beyond Celiac focuses our advocacy efforts on maximizing investment of public funds in research and public policy supporting these desired outcomes.
Our community has the power to drive change by encouraging our legislators to support initiatives that make it easier for people with celiac disease to safely consume gluten-free foods, beverages, medications and supplements AND to drive funding for celiac disease research.
On Apr 19, 2022, the The Food and Drug Administration (FDA) announced the draft guidance “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” The guidance proposes that the FDA should only consider adding a food to the top 9 allergens when it elicits certain IgE-mediated immunologic reactions (among other criteria). This would prevent any petitions to add barley or rye to the top 9 list from moving forward.
We firmly oppose this guidance. Read our full response.
The commenting period has closed. Thanks to all of those who used our sample text to comment on the FDA website!
In August 2021, Representatives Frank Pallone, Jr. (D-NJ) and Rosa DeLauro (D-CT), along with Senators Richard Blumenthal (D-CT), Sheldon Whitehouse (D-RI) and Ed Markey (D-MA) reintroduced the Food Labeling Modernization Act of 2021 (FLMA) to the House and the Senate. This bill is extremely significant for those living with celiac disease and non-celiac gluten sensitivity as it requires all manufacturers to disclose any gluten-containing grains on their labels.
Beyond Celiac supports the Food Labeling Modernization Act (H.R 4917/S. 2594) and encourages everyone in our community to contact their representatives and senators to urge them to support it as well.
Those wishing to get involved can copy and paste the following sample letter and share with your representatives. Adding personal stories and experiences is also encouraged:
We need your support for a new bill that requires that products disclose gluten-containing grains on labels.
Congressman Pallone and Senator Blumenthal have reintroduced an important Bill into the House and the Senate: The Food Labeling Modernization Act of 2021 (FLMA). The FLMA is a comprehensive effort to address numerous food labeling issues and includes amending FALPCA (Food Allergen Labeling and Consumer Protection Act) to require that food product packaging must disclose gluten-containing grains.
This Bill amends FALPCA. If an FDA-regulated food product includes a gluten-containing grain, this must be disclosed in the ingredients list or separate Contains statement – just like for wheat and the other major allergens. This would be required regardless of whether the food was labeled gluten-free.
Thank you for your support of H.R 4917/S. 2594.
The bipartisan NIH Clinical Trial Diversity Act was developed with input from a variety of stakeholder groups including NIH, HHS, AdvaMed, PhRMA, BIO, ASCAN, and FasterCures. The bill is endorsed by No Health Without Mental Health, National Organization for Rare Diseases, Leukemia and Lymphoma Society, Faster Cures/Milken Institute, the Association of Black Cardiologists, the American Psychological Association, as well as Beyond Celiac. The bill is headed up by Congresswoman Robin Kelly, and current co-leads include Butterfield, Cárdenas, Clarke, and Fitzpatrick.
On August 24, 2021, the Congressional Celiac Disease Caucus was launched with the goal of advancing legislation that will support the needs of the celiac disease community and address the need for increased federal funding for celiac disease research. Importantly, it will work to raise awareness of celiac disease across congressional districts.
A congressional caucus is composed of a group of members of the United States Congress that meets to pursue common legislative objectives. Introduced by Congresswoman Betty McCollum (DFL-Minn.), this bi-partisan Congressional Celiac Disease Caucus will provide the impetus to address the needs of the celiac disease community directly.
Along with Congresswoman McCollum, the inaugural members of this caucus are Representatives Jake Auchincloss (D-MA), Earl Blumenauer (D-OR), Matt Cartwright (D-PA), Madeleine Dean (D-PA), Brian Fitzpatrick (R-PA), Josh Gottheimer (D-NJ), Chrissy Houlahan (D-PA), John Joyce (R-PA), Tim Ryan (D-OH), Mary Gay Scanlon (D-PA), Glenn Thompson (R-PA), David Trone (D-MD), and Susan Wild (D-PA).
Our immediate goal is to increase the strength of this caucus by encouraging representatives to join the Congressional Celiac Disease Caucus. Please contact your Congresspeople asking them to join the Congressional Celiac Disease Caucus in order to make progress in addressing the needs of the 3 million Americans with celiac disease.
Call or write to your Congresspeople and request that they join the Congressional Celiac Disease Caucus today!
Download a sample letter to send to your Representatives asking them to join the Congressional Celiac Disease Caucus in order to make progress in addressing the needs of the 3 million Americans with celiac disease.
The RISE Act would authorize approximately $25 billion in emergency relief for federal research agencies. This crucial funding will help prevent life-saving medical, public health, and scientific progress from becoming another of COVID-19’s victims.
Download a sample letter to send to your congressperson.
On April 8, 2021, Representatives Tim Ryan (D-OH) and Steve Stivers (R-OH) reintroduced the Gluten in Medications Disclosure Act to the House floor. This legislation would require drug manufacturers to label medications’ ingredients, their source, and whether gluten is present. (Learn how to help get this bill passed here.)
If passed, these bills would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications.
Contact your representatives and encourage them to support these legislative initiatives.
July 2021
Step therapy is a tool used by health plans to control spending on patient’s medications. While step therapy can be an important tool to contain the costs of prescription drugs, in some circumstances, it has negative impacts on patients, including delayed access to the most effective treatment, severe side effects, and irreversible disease progression. Currently, when a physician prescribes a particular drug treatment for a patient, the patient’s insurance company may require them to try different medications and treatments before they can access the drug originally prescribed by their physician. This protocol is known as “step therapy” or “fail first.” Step therapy protocols may ignore a patient’s unique circumstances and medical history. That means patients may have to use medications that previously failed to address their medical issue, or – due to their unique medical conditions – could have dangerous side effects.
March 2021
The RISE Act would authorize approximately $25 billion in emergency relief for federal research agencies. This crucial funding will help prevent life-saving medical, public health, and scientific progress from becoming another of COVID-19’s victims.
February 2021
The Benefits Act of 2021 (S. 373) will provide patients and advocates the ability to play a larger role in the Food and Drug Administration’s (FDA) benefit-risk framework for drug approval and will accelerate patient-focused drug development strategies more broadly.
In February 2021, U.S. Senators Roger Wicker, R-Miss., and Amy Klobuchar, D-Minn., reintroduced the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT Act).
“For our health care system to better serve patients, it’s crucial that we consider their experience in the Food and Drug Administration’s drug approval process,” Klobuchar said. “Building on the progress of the 21st Century Cures Act, our legislation will help prioritize the needs of patients and ensure they are at the heart of health policy.”
The BENEFIT Act (S. 373) would require the FDA to include how patient experience data was considered in the review of the benefit-risk assessment framework of a new drug application
Currently, the FDA includes patient experience data in reviews, but does not indicate how such data impacted the drug approval.
Providing this information to the public, and patient communities making significant investments in developing patient-focused drug development builds on transparency from Patient-Focused Impact Assessment and will accelerate patient-focused drug development strategies more broadly.
In 2017, Senators Wicker and Klobuchar wrote the law that requires FDA to report on how patient engagement data is used in the review of approved therapies and to provide guidance to inform the development of patient engagement tools. This BENEFIT Act (S. 373) will build upon this law by enshrining valuable patient engagement information within the all-important FDA benefit-risk framework.
“Millions of Americans living with rare diseases are waiting for groundbreaking drugs that could change their lives,” Wicker said. “The BENEFIT Act would put patients first – giving them a larger role in the drug approval process as researchers work to find more breakthroughs.”
November 2020
BEYOND CELIAC URGES LEGISLATORS TO PASS THE SAFE STEP ACT TO LIMIT PATIENT OUT-OF-POCKET COSTS AND A SHIFT OF COSTS TO PATIENTS
Otherwise known as a “fail first” protocol, step therapy mandates that patients try and fail medications preferred by their insurer before the insurer will cover treatments prescribed by their doctors, a measure designed to save costs. Evidence shows that impeding the doctor-patient relationship and delaying access to essential treatments can increase costs for all stakeholders, and negatively impact a patient’s health.
Watch Patient Access to Care and Treatment in a Cost-Shifting Era: Preserving the Patient-Provider Decision-Making Relationship.
July 2020
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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.
On April 8, 2021, Representatives Tim Ryan (D-OH) and Steve Stivers (R-OH) reintroduced the Gluten in Medications Disclosure Act to the House floor. This legislation would require drug manufacturers to label medications’ ingredients, their source, and whether gluten is present. (Learn how to help get this bill passed here.)
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.
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.
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.
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).
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.
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.
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.
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.
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.
Ongoing Advocacy for Safe Medications
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