Generic entry, reformulations and promotion of SSRIs in the US
Generic entry, reformulations and promotion of SSRIs in the US
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DOI：
10.2165/00019053-200826070-00007
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发表时间：
2008-01-01
影响因子：
4.4
通讯作者：
Frank, Richard G.
中科院分区：
文献类型：
--
作者：
Huskamp, Haiden A.;Donohue, Julie M.;Frank, Richard G.
背景：先前的研究表明，制造商对品牌药物的促销策略通常受到仿制药条目的影响。然而，对于延长专利寿命的新策略（包括产品重新配方的引入或获得额外临床适应症的上市批准）如何影响推广，人们知之甚少。目的：探讨促销费用与仿制药申报、再制剂申报和新适应症审批之间的关系。方法：我们使用了1997-2004年期间全国产品级促销支出（包括医生详细说明和直接面向消费者广告[DTCA]的支出，以及在医生办公室分发的免费样品的零售价值）的季度数据。我们估计了详细的计量经济模型，DTCA和总季度促销支出作为仿制药进入时间的函数，新产品配方的进入和美国FDA批准SSRI类现有药物的新临床适应症。制药商用于推广抗抑郁药物的支出是主要的结果衡量指标。结果：在1997-2004年期间，在SSRIs的促销支出组成方面存在相当大的变化。当分子的重新配方被引入时，原品牌分子的促销支出急剧下降。进入仿制药后，特定分子的促销支出（包括总支出和细节支出）通常低于之前，尽管仿制药对促销支出的影响似乎与制造商所追求的产品重新配方策略的选择密切相关。在制造商获得FDA批准将帕罗西汀(R)用于广泛性焦虑症（GAD）的销售后，帕罗西汀(R)的详细支出增加了，而该药物的DTCA支出的可能性没有改变。相比之下，FDA批准销售帕罗西汀(R)和左洛复(R)治疗社交焦虑障碍（SAD）并不影响制造商的详细支出，但确实导致了更大的DTCA支出的可能性。结论：引入新产品配方似乎是一种常见的策略，试图延长市场专有权的药物面临即将进入仿制药。在仿制药进入市场之前，制造商将大部分促销资金从原品牌转移到仿制药进入市场之前，在某些情况下，制造商似乎针对特定适应症的特定促销类型。鉴于药品促销对美国处方药需求的重大影响，这些发现对处方药支出和公共卫生具有重要意义。
Background: Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion.Objective: To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval.Methods: We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure.Results: Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil (R) were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil (R) and Zoloft (R) for social anxiety disorder (SAD) did not affect the manufacturers' detailing expenditures but did result in a greater likelihood of DTCA outlays.Conclusion: The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers who introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact that pharmaceutical promotion has on demand for prescription drugs in the US, these findings have important implications for prescription drug spending and public health.