What Exactly Is Gluten?
Gluten is a protein found in wheat, rye, and barley. Per the Celiac Disease Foundation, celiac disease is an autoimmune disorder that can occur in genetically predisposed people. When people with celiac disease eat gluten, their body mounts an immune response that attacks the small intestine. This can lead to damage that prevents nutrients from being properly absorbed into the body. Left untreated, it can also lead to the development of other autoimmune disorders like Type I diabetes and multiple sclerosis.
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The Lawsuit
The lawsuit has been filed by Michael Weber, a medical assistant who suffers from celiac disease. After taking a generic drug, he suffered from an adverse reaction consistent with ingesting gluten. He then contacted the manufacturer and determined the generic drug contained gluten. In 2008, he petitioned the court to either remove gluten from its list of safe inactive ingredients in drugs or require new labeling on drugs containing the protein. The FDA sought public comments on the issue in 2011, but otherwise has not taken action. Mr. Weber has now filed this lawsuit against the FDA.
Many prescription and over-the-counter (OTC) drugs contain gluten, which is used as an excipient in medications. An excipient is an inert substance added to a drug to give a suitable consistency or form to the drug. Mr. Weber is arguing that pharmaceutical manufacturers have a variety of excipients at their disposal to use as alternatives to gluten. Celiac disease affects about one percent of the U.S. population, according to the National Foundation for Celiac Awareness, and the use of gluten and the lack of labeling regarding gluten used in prescription and OTC medications can lead to those with the disease suffering from adverse affects from its ingestion.
Gluten in Pharmaceuticals
According to the Wall Street Journal, “it’s not clear exactly how many medicines contain wheat gluten.” As the National Foundation for Celiac Awareness reported to the Wall Street Journal, this lack of a database of drugs containing gluten highlights the need for comprehensive research to identify safe thresholds of gluten in medication and its impact on the users of those medications who suffer from celiac disease. The Drug Information Service (DIS) at Robert Wood Johnson University Hospital (RWJUH) has published through the American Journal of Health-System Pharmacy a preliminary database for the identification of the presence of gluten in excipients of prescription medications. To obtain this information, DIS contacted the drug manufacturers to determine whether their products contain gluten. At the time of the publication, the DIS had received queries for about 84 medications and has cataloged their gluten content.
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Consumer Healthcare Products Association’s Response
The Consumer Healthcare Products Association (CHPA) is the national trade association representing the manufacturers and distributors of OTC medicines and dietary supplements in the U.S. The CHPA submitted a response to the FDA’s request for comments on gluten in drug products in 2012. In its comments, the CHPA encourages the FDA to work with the industry to develop and discuss alternatives to an ingredient ban, such as labeling and allowable limits for gluten-free drug or dietary supplement products. The CHPA also argues that “the amount of gluten in finished OTC drug products where gluten is not intentionally added is minute, especially when compared to intake via the food supply. Banning use of ingredients derived from specific grains would disrupt the supply chain, resulting in major reformulation of products. Reformulation to ensure elimination of gluten would have significant consequences to manufacturing cost and resources.”
Ashcraft & Gerel is keeping a close eye on the developments in this case and will report any updates as they become available.