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Full-Text Articles in Law
Change In Regulation Is Necessary For Genetically Engineered Mosquitoes, Insung Hwang
Change In Regulation Is Necessary For Genetically Engineered Mosquitoes, Insung Hwang
Michigan Journal of Environmental & Administrative Law
Millions of genetically engineered (GE) mosquitoes could soon be released in Key West, Florida as an effort to eradicate wild mosquitoes that are transmitters of diseases such as malaria, dengue, and chikungunya. Both international and domestic regulations fail to provide effective regulatory schemes that can facilitate the application of this technology while ensuring all safety and environmental aspects are properly addressed. The Food and Drug Administration’s assertion of jurisdiction is based on its assessment that the GE mosquitoes are “animal drugs” under the Federal Food, Drug, and Cosmetic Act. This is especially troublesome because the end goal of using these …
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Articles
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …