1. Food and Drug Administration – Food and drugs are consumed and used by every American so regulation put in place by the FDA also affects all Americans. It is due to this wide scope that I am interested in FDA regulation.
2. The FDA proposes to amend the sterility test requirements for biological products. This Proposed rule is intended to provide manufactures of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products.
3. It is proposed that the requirement to test the sterility for most bulk materials will be eliminated; instead these products will be tested once in the final, small, packaging. To comment on this, I think that it should still be mandatory to test the bulk material. What if the bulk material is not tested and the sterility has been compromised. This will not be discovered until after the material has gone through the packaging process, effectively wasting time and money. I believe it will be more beneficial to the company to use new technologies to test sterility in bulk before initiating the packaging process.
4. The deadline for comment is September, 19 2011
5a.Once submitting my comment on this regulation, I will have the ability to challenge whether the regulation is valid through the courts. 5b. The five legal theories that can be used to deem the regulation invalid in court are: * A rule can be deemed arbitrary and capricious if there is no evidence to support it. This theory is used for informal rule making. * In the review of formal and hybrid rules, the Substantial Evidence Test can be applied when substantial evidence is not present.
Evidence for the Substantial Evidence Test must be more convincing than evidence used for Arbitrary and Capricious * If an agency does not follow the proper APA process of rule making such as the requirements of notice, publication and public comment to ensure the rule is not deemed invalid. This is the third legal theory. * A rule or regulation can be challenged based on whether it is unconstitutional. Any regulation that limits based on race, color, religion, sex, and sexual orientation could be deemed unconstitutional, for example. * The fifth theory is utilized when an agency attempt to put a regulation in place that is actually doesn’t have the authority to put in place.
This is called Ultra Vires or “beyond it’s powers” 5c. The Substantial Evidence Test would be the best way to challenge the sterility requirement changes the FDA is proposing, specifically to the change concerning bulk materials. There is no evidence given that shows how eliminating testing bulk materials for sterility will be beneficial to the company or product involved and since sterility for these products is of empirical importance, substantial evidence needs to be presented.