It's not easy to find your way through the gov documents to locate public submissions to the FDA regarding public commentary on gluten in medications. After a bit of whining (message to "person in charge" of this particular "docket") I was directed through the maze of links to get there. To view all comments click HERE.
Here is one of 46 comments submitted (I posted mine earlier). This one by Ian Taylor, MD on behalf of the American Gastroenterological Association. The AGA strongly supports clear labeling of gluten and that information be available to pharmacists and others about gluten in medications:
March 20, 2012
Margaret Hamburg, M.D. FDA Commissioner Food and Drug Administration Division of Dockets Management (HFA‐305) 5630 Fishers Lane, Rm.1061
Rockville, MD 20852
Re: FDA–2011–N–0842 Gluten in Drug Products; Request for Information and Comments
Dear Commissioner Hamburg:
The American Gastroenterological Association (AGA) is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. The AGA appreciates the opportunity to provide comments on the request for information regarding gluten in drug products.
Celiac disease is an increasingly‐common, lifelong condition affecting as many as two million Americans. The only effective treatment for this is a gluten‐free diet, wherein the affected individual must avoid ingesting any gluten, i.e. the protein from wheat, barley and rye. The patient must remain highly vigilant in terms of hidden glutens in food or other ingested materials. The diet is not only difficult to follow, but patients must be aware of the non‐obvious gluten; even non‐food sometimes may be a problem. Very low doses or concentrations of gluten may be sufficient to cause inflammatory changes and/orsymptoms in patients with celiac disease. Doses as low as 50 mg have been shown to induce change.
The median age at diagnosis of celiac disease in the United States is 45 years. Many patients are diagnosed in advanced adulthood by which time they often need prescription medications for common conditions like hypertension. A frequent concern among patients and their doctors is whether their medications could contain gluten. This fear or concern leads to often‐difficult interrogations of patient’s medications by their pharmacists and physicians.
It is the view of the AGA that no ingredient derived from wheat, barley or rye should be included as part of any incipient ingredient in medications, over‐the‐counter or prescription. The only exceptions to this would be derivatives that have been proven to have a concentration of less than 20 parts/million verified by an assay sensitive for these proteins. Any medication wherein these ingredients exceed or could exceed >20 parts/million threshold need to be clearly labeled as “gluten‐containing.” This labeling must be clearly evident to the pharmacist and patient, as well as declared on the insert.
There are many reasons why we believe that this should be so. Firstly, the difficulty of getting accurate information on gluten content makes life very difficult for manufacturing, physicians, pharmacists, and patients with celiac disease. This is further exacerbated by the wide use of generic medications, which are often interchangeable in patients from one prescription refill to another. This often occurs due to contracting or changes in insurance coverage by patients. Secondly, the essential nature of many medications for patients’ wellbeing and the hazard that patients avoid medications because of fear of gluten contamination is another reason why medications should generally be free of gluten. Thirdly, there should be consistency within the FDA
between the food branch and the regulatory branch for medications. Currently, foods cannot contain wheat unless they are so labeled. At a minimum, this should apply to medications. Wheat is one of the listed common allergens that require specific labeling on foods under the FANA 2004.
The impact of avoiding gluten medications could be many fold. 1. This would have a substantial, reassuring effect on patients,
pharmacists, and physicians caring for patients with celiac
disease. 2. It would have significant time saving for any of these
individuals. 3. It may improve compliance of patients with their therapies. 4. There should be a cost saving to these patients as generic
medications would be interchangeable with no need to order
“dispense as written.” 5. Pharmacists would be clearly able to reassure clients of the
gluten‐free nature of the medications. 6. Doctors who care for celiac disease patients can prescribe freely
without the time wasting or without the concern regarding potential contamination or patient compliance with either prescribed medication or the gluten‐free diet.
It is possible that there could be some impact on the pharmaceutical industry for this change; however, as most of the incipient ingredients are likely sourced from relatively few manufacturers, it should not take a major change. It may be easier for the pharmaceutical company’s consumer/medical information line to accurately inform patients, pharmacists and physicians on gluten content of their products. In addition, the major source of starch in the U.S. is corn. Wheat is a major source of starch in other jurisdictions, such as Europe. It would seem to be economically beneficial to the U.S. to base much of the starch used as a filler on the dominate grain source available in the U.S. We believe that whatever temporary or minor impact there might be on the U.S. pharmaceutical industry will be minor compared to the
savings and improvement of quality of life and efficiencies in caring for patients with celiac disease.
Thank you for your consideration of AGA’s comments on the presence of gluten in drug products. If we may provide additional information, please contact Elizabeth Wolf, AGA director of regulatory affairs, at 240‐482‐3223 or firstname.lastname@example.org.
Ian L. Taylor, MD, PhD, AGAF Chair American Gastroenterological Association