Regulation Change the Proposed Regulation Research Paper

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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.

In order to set aside the regulatory changes, the court must determine that the change is arbitrary, capricious, an abuse of discretion, and/or otherwise not in accordance with federal law. Agencies must provide substantial evidence to the courts in support of their proposed changes (Administrative Procedure Act 1946). Anyone who wanted to challenge the law in court could use one or more of these legal theories to do so. In the case of this particular proposed regulatory change, the best theory to use to challenge it in court would be to argue that the change is arbitrary; in this case, it would be arbitrary in that it applies to all drug companies, whether they use gluten or not, and thus puts an unreasonable financial burden on those companies to show that gluten is not used. For companies that do use gluten in their drugs, the changes put the companies at financial risk of losing customers who may have only slight reactions to gluten and for whom the benefits of the drugs would outweigh the drawbacks of the gluten exposure.

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These customers may seek out less effective gluten-free alternatives to the detriment of the drug companies. It could be argued that it should be up to pharmacies to inform patients of a drug's gluten content, and then the patient can confer with his or her doctor on whether or not that drug is still a good choice for that patient, or if an alternative is advisable and necessary......

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