Jenson Desmond, Lester Joelle, Berman Micah L
Tobacco Control Legal Consortium, a program of the Public Health Law Center, at the Mitchell Hamline School of Law, St. Paul, Minnesota, USA.
College of Public Health & Moritz College of Law, The Ohio State University, Columbus, Ohio, USA.
Tob Control. 2016 May;25(3):246-53. doi: 10.1136/tobaccocontrol-2015-052391. Epub 2016 Apr 11.
Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.
2009年的《家庭吸烟预防与烟草控制法案》的其他关键目标包括，终结烟草行业长期进行产品操纵的时代，该行为导致了更易上瘾且更具吸引力的烟草产品。该法律要求新烟草产品在销售前须经过美国食品药品监督管理局（FDA）的上市前审查。为评估FDA对其上市前审查权限的实施情况，我们审查了FDA对新产品申请的行动、行业新产品上市申请的公开数据，以及FDA的相关指导文件和公开声明。我们得出结论，FDA在实施上市前审查过程时，没有将保护公众健康作为优先事项。具体而言，FDA（1）优先审查允许推出新烟草产品的上市前申请，而不是审查市场上可能不符合规定的产品；（2）因迁就行业多次提交有缺陷的上市前申请而错误分配了资源；（3）通过允许烟草行业销售尚未完成所需审查程序的新的和改良的产品，削弱了上市前审查程序。
