Beyond Celiac Involvement in Gluten in Medications
Early in its history, Beyond Celiac, then known as the National Foundation for Celiac Awareness (NFCA), stepped into the field of advocacy when it learned that there were not any national celiac disease organizations actively involved in addressing the risk of potential inadvertent gluten ingestion through medications. The only treatment for celiac disease is to follow a strict gluten-free diet for life. As gluten can be found in medication, pharmacy care is critical in the treatment of this disorder.
As with many advocacy initiatives, our work began with a personal story when former Beyond Celiac Spokesperson Heidi Collins was unable to fill a prescription one Christmas Eve for her son with celiac disease because the potential for gluten in the medication could not be identified. Since, Beyond Celiac has expanded its advocacy initiatives and currently focuses 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.
A key component of Beyond Celiac advocacy work is supporting scientific research that aims to characterize the problem of and better understand the full scope of unlabeled gluten in medications.
Below is a list of highlights of the work of Beyond Celiac in this field:
- Former CNN anchor and former Beyond Celiac spokeswoman Heidi Collins represented Beyond Celiac and spoke along with Beyond Celiac Staff at the 2007 American Society of Health-Systems Pharmacists (ASHP) Midyear Clinical Meeting held in Las Vegas focusing on the personal impact of gluten in medications.
- Beyond Celiac and the ASHP created continuing education programming for pharmacists and hosted two well-attended Gluten in Medications Educational Session events.
- Beyond Celiac co-authored an article entitled ‘Medications: A Hidden Source of Gluten,’ which was published in the August 2009 edition of Practical Gastroenterology.
- In September 24-25, 2009, Beyond Celiac coordinated and led a workshop about Prescription Drug Risks and Benefits with the purpose of aligning the gluten-free labeling efforts being conducted in parallel by the FDA’s Center for Food Safety and Applied Nutrition (food labeling) and the FDA’s Center for Drug Evaluation and Research (OTC medications).
- In response to the FDA’s request for public input about prescription drug risks and benefits, Beyond Celiac provided comment, advocating for the labeling of gluten in medications on November 11, 2009.
- Beyond Celiac initiated an informational Gluten in Medications section of its website www.BeyondCeliac.org linking to patient education material created and developed in collaboration with ASHP.
- A Letter to the Editor submitted by Beyond Celiac was published in the January 2010 issue of Hospital Pharmacy.
- Beyond Celiac commended the Perrigo Company, a maker of OTC generic medications, for labeling their drugs with less than 20 ppm beginning in January 2010.
- Beyond Celiac President and CEO Alice Bast spoke at the American Pharmacists Association (APhA) Annual Meeting in Washington, DC in March 2010.
- In November 16-17, 2010 at the Safe Use Initiative Public Workshop, Beyond Celiac presented a statement about gluten in medications, which appealed to the FDA with regard to labeling the source of inactive ingredients that may contain gluten.
- Beyond Celiac received a grant from the FDA entitled Gluten in Medication: Qualifying the extent of exposure to people with celiac disease and identifying a hidden and preventable cause of an adverse drug event.Principal Investigators were Loretta Jay, MA and Robert A. Mangione, RPh, EdD, Provost and Professor of Pharmacy at St. John’s University. This preliminary research highlighted the need for an additional, large scale, comprehensive study identifying safe thresholds of gluten in medication, its impact on people with celiac disease, and the pervasiveness of gluten in binders and excipients.
- On behalf of the Gluten-Related Disorders Collaborative of five organizations, Beyond Celiac developed a letter in support of the proposed Gluten in Medication Act of 2012 introduced by Representatives Tim Ryan (OH) and Nita Lowey (NY). This was accompanied by a template letter that constituents could use in corresponding with their Congressional Representatives in support of the Act.
- In March 2012, Beyond Celiac delivered a document in response to the comment period for the FDA Docket Number FDA-2011-N-0842 advocating for labeling of gluten in medications.
- In May 2013, Beyond Celiac formally supported HR: 2003 – Gluten in Medicine Disclosure Act introduced by Representatives Tim Ryan (OH) and Nita Lowey (NY). This proposed bill would require all drugs to disclose any gluten-containing ingredients.
- In August 2013, Beyond Celiac was contacted by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition’s (NASPGHAN) congressional lobbyist and the Office of Senator Gillibrand (NY) to support the Gluten in Medicine Disclosure Act. This Act aims to direct the FDA to exercise its authority to issue a proposed rule within two years of the bill’s enactment to require labeling, requires a final rule within four years of enactment, and also calls for a study.
- The research team collaborating on the FDA-funded gluten in medications study completed the testing of the identified medications in spring 2014. Beyond Celiac delivered its final report to the FDA in fall 2014.
- In September 2015, Beyond Celiac formally supported HR 3648 – Gluten in Medicine Disclosure Act of 2015 introduced by Representatives Tim Ryan (OH) and Nita Lowey (NY). This bill would require all drugs to disclose any gluten-containing ingredients. This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of any drug intended for human use that contains an ingredient other than a polyol that constitutes or is derived from a grain or starch-containing ingredient and whose label does not include a parenthetical statement identifying the source of that ingredient.
- In December 2015, Allergic Living magazine published an article entitled “Gluten in Our Meds.” The article addressed the concerns about gluten on medications and the need for labeling. It recognized the Beyond Celiac role in working to a solution – our survey, FDA grant for research in gluten in medications, focusing on the need for labeling.
- In December 2015, Pharmacy Today, a publication of the American Pharmacists Association (APhA), published an article in the One to One column entitled “Gluten in medications: A dangerous prescription for patients with celiac disease.” The article noted that Beyond Celiac, formerly known as the National Foundation for Celiac Awareness (NFCA), “has long called for gluten to be listed on medication labels or completely removed from medications.”
- January 2018, Beyond Celiac participated in responding to the FDA’s Gluten in Drug Products and Associated Labeling Recommendations Guidance for Industry.
- Requested that our community send it in responses to the FDA’s draft guidance during the open comment period. Over 800 comments were received. We drafted an example letter for our community to use in their response.
- August 2018, Beyond Celiac continues to fight for safe, gluten-free medications – read our write-up of the 6 key reasons we are committed to better labeling of prescription and over-the-counter drugs.