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。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2017-01-01
Joseph G Milner
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引用次数: 0

摘要

药物开发需要耐心。除了开发过程本身固有的不确定性之外,美国药物开发商还必须遵守美国食品和药物管理局(FDA)监督的监管批准程序。因为这个过程需要时间,药物开发也需要资金。寻求在美国资本市场融资的制药公司必须遵守美国证券交易委员会(SEC)管理的证券制度。尽管作为消费者和公共市场的保护者,SEC和FDA扮演着相似的角色,但在制药公司需要向公众披露的信息方面,它们发出了相互矛盾的信号。美国证券交易委员会主要通过强制公开披露来进行监管,而美国食品和药物管理局历来通过其预批准程序来监管药品,直到最近才开始在其监管制度中加入披露机制。此外,三项联邦法规要求FDA对制药公司提交的敏感信息保密。当上市的制药公司必须决定是否以及如何公开披露与药物开发有关的信息时,两国政权不同的优先事项和方法造成了紧张关系。本文调查了这两个机构相互冲突的优先事项和法规,并探讨了由此产生的可能给制药公司带来的问题。它建议国会放宽对FDA披露赞助商提交的机密信息能力的法定限制,以帮助缓解这些制度之间的紧张关系,并向公众提供有关制药公司及其产品的更准确信息。
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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.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
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.
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