公众需要为仿制药批准减缓付出多少？
出自识林
公众需要为仿制药批准减缓付出多少？
笔记 2014-11-18 Lachman CONSULTANTS CBS早间新闻最近播出了一条关于某些仿制药价格成本高涨的新闻。尽管该话题存在潜在分歧，但因为Jon LaPook博士和Holly Phillips对问题描述非常好，新闻平衡了各方观点。去年仿制药产品低廉的价格为美国消费者总共节省了2390亿美元，尽管估计有9.4%的仿制药去年将其价格上涨了一倍。 CBS新闻报道列举了某些价格上涨可能的原因，特定产品竞争者数量的减少、市场原因造成的产品从市场暂时退出，或原料药供应的减少。毫无疑问，仿制药价格之所以普遍偏低是针对一个特定药品有多个批准。通常情况下，特定产品进入市场的数量增加，价格下降。另外，一个有趣的现象是，有时对于特定产品，当批准数量很大时（例如，10-12个），结果是价格下降非常显著，产品对所有生产商都不能保持盈利，慢慢地，一些生产商从自己的产品线中放弃该产品以利于其它更有利可图的药品。当特定产品的供应商数量减少，价格开始攀升。而一些价格的上涨会引起患者和医疗服务提供者的惊慌，仿制药总体价格效益怎么强调也不过分。 是否有其它因素导致药品成本增长？另外一个可能的因素是仿制药批准的减缓。仿制药办公室（OGD）已认定首次仿制药批准和代表短缺的产品将根据公共卫生政策实行优先审评。但是那些竞争者减少的药品呢？请记住，FDA本身不应该为药品定价成本担忧，但还必须记住的是Hatch-Waxman法案的基本作用就是制造高质量、低成本的仿制药以努力减少相关医疗费用。 随着仿制药价格上涨故事频率的增加和国会利益支付关于这一话题的增加，业界和公众能够期望的结果是什么呢？或许一旦在FDA的积压得到控制，批准数量增加，这一问题将开始退出公众视线，但在此期间，当一位母亲再也无法支付她的药费时，她应该做些什么？当生产商数量减少到会出现药品短缺时，FDA是否应该研究具体增加药品ANDA的批准数量？在我看来，这无疑是在已经不堪重负的系统上放了一份新的负担。这显然没有简单的答案。 Lachman CONSULTANTS - Bob Pollock先生 2014-11-17 识林www.shilinx.com版权所有，未经许可不得转载。如需使用请联系zhzhao@shilinx.com What Price Could the Public be Paying for the Slow Down in Generic Drug Approvals? CBS Morning Rounds recently ran a piece on the soaring cost of certain generic drug prices (see the clip here). Despite the potential divisiveness of the topic, the piece was very balanced as Dr. Jon LaPook and Dr. Holly Phillips did a very nice job in describing the issues. The low price of generic products is universally saved American consumers $239 billion last year, although an estimated 9.4% of generic drugs doubled their price last year. The CBS piece cites potential reasons certain price increases have occurred as a decrease in the amount of competition for a particular drug product, temporary exit from the product market due to manufacturing problems, or decreases in the supply of active ingredients. There is no question that the reason generic drug prices are generally low is that there are multiple approvals for a specific drug. Typically, as the number of entrants into the market for a specific drug increases, the price decreases. Also, an interesting phenomenon is that sometimes when the number of approvals is large (say, 10-12) for a particular drug and the prices drops so significantly as a result, the product does not remain profitable for all of the manufacturers and, slowly, some of the players drop that drug from their product line in favor of other more profitable drugs. As the number of suppliers of a specific drug decreases, the price begins to creep up. While some of the price increases are alarming to patients and healthcare providers, the overall price benefit of generic drugs cannot be overemphasized. Is there another factor in increasing drugs costs? Well, one other possibility is the slowdown in the rate of generic drug approvals. The Office of Generic Drugs (OGD) has identified first time generic drug approvals and drugs that represent a shortage as examples of products for which priority review will occur based on public health policy. But what about drugs for which the number of entrants decreases? Remember that FDA is not supposed to concern itself with the cost of drug pricing, but one must also remember the basic tenants of the Hatch-Waxman Act is to make high quality, low cost generic drugs available in an effort to reduce associated healthcare costs. With the frequency of stories of generic drug price hikes increasing and Congressional interest being paid to this topic increasing, what can the industry and the public expect the outcome to be? Perhaps once the backlogs at FDA are under control and the number of approvals increase, this issue will begin to fade from the limelight, but in the interim, what’s a mother to do when she can no longer afford her medication? Should the FDA also be looking at increasing the number of ANDA approvals for specific drug products when the number of manufacturers decreases like they do when there is a drug shortage? This, in my opinion, would place a tough new burden on an already overburdened system. There is clearly no easy answer. |