Summary: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
The proposed rule would amend the current regulations on submission of changes being effected (CBE-0) supplements for safety-related labeling changes to permit abbreviated new drug application (ANDA) holders to distribute revised product labeling that differs from the labeling of its reference listed drug upon submission to FDA of a CBE-0 supplement. The proposed rule would also allow changes to the Highlights of Prescribing Information (Highlights) of drug labeling in the “Physician Labeling Rule” (PLR) format through a CBE-0 supplement. In addition, the proposed rule would establish a Web page where FDA would post information on pending CBE-0 supplements submitted for safety-related labeling changes.
拟议法规将允许ANDA持有人对标签说明做出CBE-30变更并发出致医疗保健从业人员函(Dear Health Care Provider letters),而最高法院已经表示不能这样做。也许只是我这样认为,但《联邦食品、药品与化妆品法案》其实要求标签说明与橙皮书收录的参照药品相同,FDA ANDA法规序言阐明,橙皮书收录的参照药品与仿制药标签说明一致,对避免市场混乱至关重要。但目前,FDA正在提议在2013年制造这家监管机构在过去30年间力图避免的混乱。他们的推理是,自从Hatch-Waxman法案获得通过以来,市场已经发生巨变,在美国给患者的所有配药中,仿制药已经超过80%。我断言,他们计划采取的行动是错误的,在努力降低责任风险、并因此避免原告所称的“未能警示”的同时,这样的行动会引导制药行业系统地卷入仿制药和品牌药生产商的“防御性标签”中,纳入可能报告的所有不良反应,甚至是在不能主动决定由产品引起的情况下。有可能会在某种程度上削弱标签警示的影响,使得消费者或医生只关注警告或不良事件本身。更糟的情况是,可以想见会出现这样的情形 如果市场上同一药品有10个仿制药生产商和一个品牌药生产商,理论上生产上会充斥着11种不同的标签,每种标签都会包含等待FDA审评、修改、批准或不予批准的不同警告。