在这封由GPhA总裁以及CEO Ralph G. Neas 署名的信函中，还提到了这一问题的复杂性，也提到了接下来的节日将会为提出合理的意见建议提供充足时间。
在之前的文章中【仿制药公司雪上加霜，需上报不良反应 识林资讯】，我讨论了该拟议规定对仿制药行业、FDA的重大影响以及衍生的一些法律问题。除了GDUFA立法改变了仿制药办公室(Office of Generic Drug, OGD)审评和批准过程的面貌之外，这个拟议规定有可能改变仿制药公司从1984年（甚至更早）以来的运营模式。 必须系统、合理地审视被业界以及仿制药办公室视为改变游戏规则的事件所导致的一系列无法预料的后果，以及这一拟议规定所造成的责任归属问题，来确保由Hatch-Waxman法案在品牌药和仿制药之间保持的平衡不会失常。
GPhA Requests Extension of Comment Period on Proposed Labeling Rule
Written by Bob Pollock • November 27, 2013
In a letter dated November 27, 2013, the Generic Pharmaceutical Association (GPhA) requested a 60-day extension to provide comments on the FDA’s Proposed Rule - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.
GPhA noted in their request that:
“The proposed rule includes revisions that would dramatically alter the current regulations governing generic drugs with respect to both when and how a labeling change would be required. The changes as proposed will have far reaching consequences affecting patient safety as well as health care costs. They also create an additional burden not anticipated in the business and compliance models of generic and biosimilar manufacturers and marketers.” GPhA requests this extension “to afford all interested stakeholders an opportunity to provide commentary based on a robust analysis of the various legal and commercial implications of the proposal.”
The letter, signed by Ralph G. Neas, President and CEO of GPhA, also cited the complexities of the issues raised as well as the upcoming holidays and its impact on assuring sufficient time to provide reasoned comments to the proposed rule.
In a previous post (here), I discussed the significant impact on the generic industry, FDA and some of the legal questions that this proposed rule raises. Outside of the GDUFA legislation which has changed the face of the Office of Generic Drug (OGD) review and approval process, this Proposed Rule could change the way generic companies have done business since 1984 (and before). The unintended consequences of what many in the industry see as a major game changer for themselves and OGD, as well as the implications for liability that this proposed rule may create must be evaluated in a systematic and reasoned process to assure the balance struck by Hatch-Waxman Act between the Brand Name and Generic industries is not thrown out of whack.
