{"title":"阳光和其他消毒剂:联邦证券和药物监管制度下的披露义务。","authors":"Joseph G Milner","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public. While SEC primarily regulates by mandating public disclosure, FDA has historically regulated drugs through its pre-approval process and has only recently begun to add disclosure mechanisms to its regulatory regime. Moreover, a trio of federal statutes requires FDA to keep sensitive information submitted by drug companies confidential. The regimes’ distinct priorities and approaches create tensions that surface when publicly traded drug companies must decide whether and how to publicly disclose information related to drug development. This paper surveys the two agencies’ conflicting priorities and regulations and explores the resulting problems that can arise for drug companies. It recommends that Congress liberalize statutory restraints on FDA’s ability to disclose sponsor-submitted confidential information in order to help alleviate the tensions between these regimes and provide the public with more accurate information about drug companies and their products.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":null,"pages":null},"PeriodicalIF":0.3000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Sunlight and Other Disinfectants: Disclosure Obligations under the Federal Securities and Drug Regulatory Regimes.\",\"authors\":\"Joseph G Milner\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public. While SEC primarily regulates by mandating public disclosure, FDA has historically regulated drugs through its pre-approval process and has only recently begun to add disclosure mechanisms to its regulatory regime. Moreover, a trio of federal statutes requires FDA to keep sensitive information submitted by drug companies confidential. The regimes’ distinct priorities and approaches create tensions that surface when publicly traded drug companies must decide whether and how to publicly disclose information related to drug development. This paper surveys the two agencies’ conflicting priorities and regulations and explores the resulting problems that can arise for drug companies. It recommends that Congress liberalize statutory restraints on FDA’s ability to disclose sponsor-submitted confidential information in order to help alleviate the tensions between these regimes and provide the public with more accurate information about drug companies and their products.</p>\",\"PeriodicalId\":12282,\"journal\":{\"name\":\"Food and drug law journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2017-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Food and drug law journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and drug law journal","FirstCategoryId":"97","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
Sunlight and Other Disinfectants: Disclosure Obligations under the Federal Securities and Drug Regulatory Regimes.
Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public. While SEC primarily regulates by mandating public disclosure, FDA has historically regulated drugs through its pre-approval process and has only recently begun to add disclosure mechanisms to its regulatory regime. Moreover, a trio of federal statutes requires FDA to keep sensitive information submitted by drug companies confidential. The regimes’ distinct priorities and approaches create tensions that surface when publicly traded drug companies must decide whether and how to publicly disclose information related to drug development. This paper surveys the two agencies’ conflicting priorities and regulations and explores the resulting problems that can arise for drug companies. It recommends that Congress liberalize statutory restraints on FDA’s ability to disclose sponsor-submitted confidential information in order to help alleviate the tensions between these regimes and provide the public with more accurate information about drug companies and their products.
期刊介绍:
The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products.
Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law.
All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.