Regulation Change the Proposed Regulation

Regulation Change

The proposed regulation change this paper examines is being proposed by the FDA. The change in question regards making information on gluten in federally regulated drug products available to the public, so that those with celiac disease (an intolerance to gluten) can avoid these drugs. The change also takes into consideration the possibility of removing gluten from all drug products in the United States if it is determined that doing so will not have any negative effects on the drugs themselves (Gluten in Drug Products 2011).

I am interested in this topic because I know quite a few people who have celiac disease and/or who are intolerant to gluten in various ways. With some of these people I know, it takes a moderate portion of gluten for them to experience any negative effects. However, with some of them, all it takes is just the smallest trace amount to produce a reaction. If they were to take a drug with gluten in it, it could potentially be harmful to them, as gluten makes them sick in a variety of ways from digestive troubles to hives. Therefore, knowing whether or not a drug product contained gluten in even trace amounts would be beneficial to them and to millions of people in the United States who have celiac disease and/or gluten intolerance. This proposed change will not affect my work in any way. My interest in the proposed change is a personal one.

Public comments are still open on this proposed change until March 20, 2012. Were I to comment on this change, I would submit this: "Celiac disease and gluten intolerance are serious health issues that affect millions of people in the United States. Knowing what products they are consuming orally contain is very important to the health of these people; therefore, knowing if something they are going to ingest has gluten in it, even in trace amounts, is information they need to have before consuming anything. If gluten is ingested, even in small amounts, these people can become very sick, with all kinds of unpleasant symptoms. Allowing the public to know whether or not a drug product contains gluten is a public health concern that needs to be addressed, and the proposed change does this. The suggestion of the FDA to possibly eliminate gluten from drug products in the United States altogether if it can be shown that doing so would not harm the effectiveness of the drugs is also a positive step in the right direction. I believe this change should be implemented as soon as possible, and I fully support it."

The public commenting period is near the end of the promulgation process, after a bill has become law. The public comments are taken into account by the agency affected by the law when the agency is putting together its regulations to comply with and enforce the law. There is little that can be done to change the law at this point, other than to challenge it in the courts. However, earlier in the promulgation process, when a proposed regulatory change is still before Congress, it is possible to get invited to give testimony on the proposed change before a Congressional hearing, if a person is familiar with the subject at hand and intimately involved with it.