Lawsuit would force FDA to ban or label wheat gluten as ingredient

There are no drugs approved for treating celiac disease, an autoimmune condition that stems from a reaction to wheat gluten. But plenty of drugs can make it worse because they contain gluten as an excipient, and those with celiac have no idea which ones they are. Celiac sufferer Michael Weber has been trying for 7 years to change that and has now sued the FDA for dragging its feet on a citizen petition he filed in 2008.

The lawsuit, filed Monday in federal court in Washington, DC, attempts to force the FDA to either ban gluten from use in drugs or at least require labels to indicate it is an ingredient in prescription and over-the-counter drugs. It points out that because it is considered a "major allergen" it is required by federal law to be labeled as an ingredient in food but not in drugs. The FDA told the blog Pharmalot that it did not comment on pending litigation.

The lawsuit says an estimated 1% of the population suffers from celiac disease, which can cause abdominal pain, diarrhea, constipation and vomiting. In children it might stunt growth or delay puberty. Prolonged exposure to gluten can affect fertility and increases the chance of getting intestinal cancer. In other words, it can kill you. What's the treatment? A gluten-free diet.

According to Weber's lawsuit, drugmakers sometimes use wheat gluten as a filler starch or in the coating of a capsule or tablet. But because generics can use different ingredients from branded drugs and different generics of the same drug may as well, celiac sufferers have a very difficult time figuring out if the medications that are supposed to make them better are going to cause a flare-up.

Of course Weber pointed all this out to the FDA when he first filed his petition in 2008. But not much has happened on it since. When he asked for a status update in 2010, the FDA said it was still under review. The agency did ask for public comment in 2011 and got 138 responses. Groups like the American Academy of Pediatrics and the North American Society for Pediatric Gastroenterology said gluten should be banned.

The International Pharmaceutical Excipients Council of the Americas and the Consumer Healthcare Products Association (CHPA) said that if the FDA were to act, they would prefer the labeling route. As the blog Pharmalot points out, in its comments to the FDA, the CHPA said that "banning use of specific grains would disrupt the supply chain, resulting in major reformulation of products." That, it said, would "have significant consequences to manufacturing cost and resources."

The FDA has had drugmakers label specific drugs that can cause allergic reactions in some patients. It ordered such a label change for Merck's ($MRK) antipsychotic treatment Saphris in 2011, saying that prescribers should watch for anaphylaxis, swelling, low blood pressure and a swollen tongue. Drugmaker Affymax and its partner Takeda pulled the new anemia drug Omontys from the market in 2013 after three patients died from allergic reactions. Unable to recover, Affymax dissolved last year.

Some food companies have taken up the challenge. There are pizza chains that offer a gluten-free slice and beermakers that offer a gluten-free cold one to go with that. But three years after seeking public input, the FDA was still undecided. Weber asked the FDA for an update again last summer. In a letter the FDA told him it would "respond as soon as we have reached a decision on your request." Figuring enough was enough, Weber sued this week.

- here's the lawsuit (PDF)
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