挑战立即暂停DEA注册:是时候采取新策略了吗?

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2014-01-01
Douglas J Behr
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引用次数: 0

摘要

对于开处方、储存和分发管制药物的医生、药剂师、医院和药品批发商来说,美国禁毒署(DEA)的注册不仅是必需品,而且是无价的商品。虽然DEA只能在单方面发现“对公众健康或安全的迫在眉睫的危险”后通过发布立即暂停令(“ISO”)暂停注册,但法律未能通过ISO暂停后听证会的方式明确保护注册人,尽管注册人在注册中的财产利益受到宪法保护。注册人只有两种程序选择——通常是不成功的——挑战ISO:忍受漫长而艰巨的行政审查程序,或向法院申请“不太容易证明”的禁令,在此期间暂停仍然有效,受控物质业务停止运营。因此,暂停注册可能会导致医生和药剂师在没有注册的情况下没有经营业务的财政手段而死亡。因为DEA注册是受宪法保护的利益,所以有更好的方式来挑战暂停。最高法院认为,一旦颁发许可证,继续持有许可证对注册人的生计至关重要。因此,暂停或撤销这种受保护的利益需要正当程序。正当程序听证会虽然各不相同,但将提供必要的审查途径,以公平审查暂停和继续暂停的理由,即是否真的对公共健康或安全构成迫在眉睫的危险,以及暂停是否过于广泛,应加以限制。到目前为止,这一论点仍有待检验,并等待请愿人提出可诉性索赔和财政资源,在法庭上挑战DEA。但是在DEA领域的ISO挑战中,是时候采取新的策略了!
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Challenging an immediate suspension of a DEA registration: is it time for a new tact?

A Drug Enforcement Administration ("DEA") registration is not only a necessity, but also an invaluable commodity for doctors, pharmacists, hospitals and drug wholesalers who prescribe, stock, and distribute controlled substances. While the DEA may only suspend a registration by issuing an immediate suspension order ("ISO) after an ex parte finding of "imminent danger to the public health or safety," the law fails to explicitly protect the registrant by way of a post-suspension hearing on the ISO, despite the registrant's constitutionally protected property interest in the registration. A registrant has only two procedural options--which are often unsuccessful--to challenge the ISO: endure a long and arduous administrative review proceeding or petition the court for a "not-so-easily proven" injunction, all the while the suspension remains in effect and the controlled substance business operations cease. Accordingly, a suspension of the registration may be certain death to doctors and pharmacists without the financial means to operate the business in the absence of the registration. Because the DEA registration is a constitutionally-protected interest, there is a better way to challenge the suspension. The Supreme Court has held that once a license is issued, the continued possession of it is essential to the registrant's livelihood. Therefore suspension or revocation of such a protected interest requires due process. Due-process hearings, while varied, will provide the necessary avenues of review to provide a fair review of the justification of the suspension and its continuance, i.e., whether there truly is imminent danger to public health or safety and whether the suspension is overbroad and should be limited. To date, this thesis remains to be tested and awaits a petitioner with a justiciable claim and the financial resources to challenge the DEA in court. But in the field of DEA ISO challenges, it is time for a new tact!

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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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