{"title":"Taking Action to Topple the Great Wall Around American Pharmaceutical 'Trade Secrets'","authors":"Connor D. Hicks","doi":"10.2139/SSRN.3842489","DOIUrl":null,"url":null,"abstract":"The Food and Drug Administration is one of the most stringent regulatory bodies in the world. As American consumers continue to ingest more pharmaceuticals yearly, the ingredients within these products are increasingly outsourced. Due to the strict oversight of the FDA, American pharmaceutical companies have moved towards outsourcing the majority of ingredients abroad, specifically to China and India. While these products are consumed by millions of Americans daily, inspection occurs only at import, and the ingredients are then assembled domestically and sold as if they were made entirely in the United States. \n \nBecause these ingredients come from facilities that are largely under-regulated, this presents a legitimate risk to the health of consumers. Beyond that, the average consumer does not even know, because the companies claim this sourcing information to be protected by “trade secret” and thus not a required disclosure. As China and India gain a larger share of the pharmaceutical market yearly, it is essential that Congress take action to ensure proper oversight of the ingredients in U.S. products and necessary disclosure to the consumer.","PeriodicalId":128340,"journal":{"name":"PharmSciRN: Pharmaceutical Intellectual Property Protection (Topic)","volume":"11 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2021-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"PharmSciRN: Pharmaceutical Intellectual Property Protection (Topic)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2139/SSRN.3842489","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1
Abstract
The Food and Drug Administration is one of the most stringent regulatory bodies in the world. As American consumers continue to ingest more pharmaceuticals yearly, the ingredients within these products are increasingly outsourced. Due to the strict oversight of the FDA, American pharmaceutical companies have moved towards outsourcing the majority of ingredients abroad, specifically to China and India. While these products are consumed by millions of Americans daily, inspection occurs only at import, and the ingredients are then assembled domestically and sold as if they were made entirely in the United States.
Because these ingredients come from facilities that are largely under-regulated, this presents a legitimate risk to the health of consumers. Beyond that, the average consumer does not even know, because the companies claim this sourcing information to be protected by “trade secret” and thus not a required disclosure. As China and India gain a larger share of the pharmaceutical market yearly, it is essential that Congress take action to ensure proper oversight of the ingredients in U.S. products and necessary disclosure to the consumer.