首页 > 资讯 > Rx vs OTC— 争论仍在继续

出自识林

2014-11-14 Lachman CONSULTANTS

2014年11月12日，FDA对2014年9月23日给药品审评和研究中心主任Janet Woodcock的信作出回应，同时也提交相同内容到备案号FDA-2012-P-0566关于PEG3350用于儿科患者的安全性。大论战的范围比儿科安全性更广泛；包括一份FDA决定说明，当产品完全从处方转到OTC（非处方）状态，产品不可再凭处方销售。

在这里相关的案例是曾经仅是处方产品，现在仅作为OTC使用的Miralax；其它仿制等效产品是通过仅凭处方使用的ANDA获得批准。仿制药生产商已经争论多年，认为存在遗留的处方适应症和用途应允许继续销售处方产品。FDA并不认同，且开始清除市场上的处方版本。

如果不重复整个争论（顺便说一下，这已成为业界和FDA多年来为许多其它产品争论的焦点），（至少针对这一产品）最终的决定正在酝酿之中。如上所述，FDA的回应包含了附加在拟议最终通知中的对决策过程的综合评价。提前发布似乎有些不太寻常，尽管如此，内容仍非常翔实。

现在FDA已经概述了对这一具体产品立场的法律和监管理由，我相信法律专家将在最终通告中解析措辞寻找方法，从而确保客户获得最为成功的处方药到OTC药转变的生命周期管理，确保仿制药申请人可以寻求在法律上尽可能继续销售处方版本产品的方法。

Lachman CONSULTANTS - Bob Pollock先生 2014-11-14
编译：识林-椒 2014-11-14

Rx vs OTC- the Debate Continues
Written by Bob Pollock • November 14, 2014

On November 12, 2014, the FDA responded (here) to a September 23, 2014 correspondence to Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research and also submitted the same to Docket No. FDA-2012-P-0566 regarding the safety of PEG 3350 for pediatric patients. The big debate is a bit broader than just pediatric safety; it involves an Agency determination stating that, when a product is completely switched from prescription to OTC status, the product can no longer be marketed by prescription.

The case in point here is Miralax, once a prescription only product, is now available only as an OTC; other generic equivalents were approved as ANDAs for prescription use only. The generic manufacturers have for years argued that there were leave-behind Rx indications and uses that would permit the continued marketing of the prescription product. FDA disagreed and has begun the process to remove the prescription versions from the marketplace.

Without rehashing the entire argument (which, by the way has been a bone of contention between the industry and the Agency for years and for many other products) a final decision is in the offing (at least for this product). The FDA response noted above contains a comprehensive evaluation of its decision making process in its Proposed Final Notice that was appended to the response. The advance release appears to be a bit unusual, but nonetheless very informative.

Now that the FDA has outlined its legal and regulatory rationale for its position on this specific product, I am certain that legal experts will be parsing the wording in the Final Notice looking for ways that they can assure that life cycle management of future Rx to OTC switches can be most successful for their clients and generic applicants can be looking for ways to continue marketing approved prescription versions for as long as they legally can.