FDA局长在处方药滥用峰会上的演讲
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FDA局长在处方药滥用峰会上的演讲
笔记 2016-04-12 Lachman CONSULTANTS 美国FDA局长Robert Califf医师3月29日在2016全国处方药滥用和海洛因峰会上的演讲概述了FDA应对阿片类药物滥用流行的计划，并谈到了许多重要和关键的问题，强调了摆在面前的艰苦工作。他强调，需要有涉及从业者、其他医疗服务提供者、执法人员、教育工作者和患者的多管齐下的方法。 他强调了FDA最近的工作，指出“我们的行动计划也认识到寻求新方法来配制阿片类药物以阻止为了获得更快的兴奋而进行的药品篡改，我知道这是你们正设法解决并将在这次会议上讨论的问题。上周我们发布了一份行业指南草案，将帮助企业开发滥用遏制制剂和确保具有滥用遏制制剂（ADF）的已获批阿片类药品的仿制药版本的滥用遏制不低于品牌药产品。” 这是奠定了行动计划的基础之一；然而，在其它评论中，我们开始担心，由于增加成本和限制医生和其他医疗卫生从业者用于治疗严重和临终疼痛的替代品的数量可能成为FDA对于继续批准非滥用遏制仿制药和其它滥用遏制阿片类产品立场的未来的阻碍。 虽然Califf承认“确保适当的获得滥用遏制阿片类产品的仿制药是更广泛的战略中的重要组成部分，”他接下来也表示，“我们已经注意到在开具药物处方的模式中，遏制滥用制剂没有占很大的市场份额，可能部分原因是由于市场上没有仿制制剂而需要高得多的花费。所以成本较低的仿制产品的供应具有增加滥用遏制制剂使用的潜力。”这里不确定的地方是引入同等产品来解决问题。FDA对于成本更低并且可能在某些情况下必须压碎片剂或通过鼻饲给药对患者是唯一可行的治疗药品的非滥用遏制制剂的计划是什么？此外，我不认为任何会期待一款滥用遏制仿制产品会比现有的非遏制滥用仿制药更便宜。FDA在评估其整体方法时，必须保证成本和治疗方式的可获得性不受限制。 Califf也承认关于FDA能做的工作可能存在限制，指出“有些人表示FDA减少阿片类药物使用的一种方法是限制其批准的阿片类产品数量。但根据现行法律，我们能做的有限。根据现行法律，FDA有责任批准仿制药申请，除非该产品未能证明生物等效于原研产品或不符合其它标准。这是我们将在不久的将来谈论得更多的难题。”警报已经拉响。FDA对已经获批的和在研非滥用遏制制剂的仿制药准备如何行动？ “研发新的滥用遏制产品的一个基本条件是具有对现有ADF产品影响的必要数据，”这也是对某些仿制药采取任何不利行动的一条重要考虑因素。但有其它方面或许值得更多关注，例如对医疗服务提供者更好的教育，例如，如Califf所说“我们需要更加强大的国家研究工作，告知医生和患者有关使用阿片类药物治疗慢性疼痛的长期获益或风险。”虽然有强制因素控制阿片类滥用和处方，还要建立国家数据库，以便药剂师和医疗服务提供者可以看到患者从其它提供者和其它司法辖区获得的处方。在我看来，FDA不应目光短浅地控制其批准的阿片类药品申请的数量，而应当是如何最好地确保恰当使用这些产品。 整个问题不能靠一把刷子来解决，在准确地全面地解决所有问题的触角的国家政策制定之前，我们也不能指望药物滥用战争取得进展。我们需要预先采取措施以确保可用、有效的产品和合理的国家政策用来应对自几十年前对毒品的战争开始以来一直未能成功解决的问题。 Lachman CONSULTANTS - Bob Pollock先生 Do the FDA Commissioner’s Remarks Spell Trouble for Generic Opioids? In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them. He emphasized that there needs to be a multipronged approach that reaches practitioners, other healthcare providers, law enforcement, educators, and patients. He emphasized what FDA has done recently by noting “Our action plan also recognizes the importance of seeking new ways to formulate opioids to discourage tampering with the drugs in order to receive a faster high, a problem that I know you’re grappling with and will talk about during this meeting. Last week we issued a draft guidance for industry that will help them develop abuse-deterrent formulations and ensure that generic versions of approved opioids with ADFs are no less abuse-deterrent than the brand name drug.” This was one of the bases of the foundation laid in the action plan; however, in additional comments, we find pause to worry about the future of the Agency’s position on continued approval of generic non-abuse deterrent and other abuse-deterrent opioids that could hamper access by increasing costs and limiting the number of alternatives that physicians and other healthcare practitioners use to treat severe and end of life pain. While Califf acknowledged that “[e]nsuring appropriate access to generic forms of abuse-deterrent opioids is an important element in that broader strategy,” he also followed by saying “[w]e’ve noticed in prescribing patterns that abuse-deterrent formulations have not taken a large share of the market, perhaps in part due to the much higher cost without generic formulations on the market. So the availability of less costly generic products has the potential to increase the use of abuse-deterrent formulations.” And here is where the uncertainty is introduced into the equation to fix the problem. What does he (the FDA) plan to do about non-abuse-deterrent formulations that are even less costly and may, in some instances, be the only viable treatment for a patient that must either crush a tablet or have it administered through a nasogastric tube? In addition, I don’t think that anyone would expect even a generic abuse-deterrent product to be less expensive than a currently available non-abuse-deterrent generic. The FDA, in evaluating its overall approach, must assure that cost and available modes of treatment are not limited. We have posted about this before here, here, and here. Califf also acknowledged that there may be limits on what FDA can do by noting “[s]ome have said that one way that FDA could reduce the use of opioids is to limit the number of opioids it approves. But there are limits to what we can do under the current law. Under the current law, FDA is obligated to approve an application for a generic drug unless the product fails to demonstrate bioequivalence to the innovator or it does not meet other standards. This is a difficult problem that we’ll be talking about more in the near future.” And with that the alarms go off. What does FDA have in store for the generic non-abuse-deterrent formulations already approved and those in the pipeline? “An essential piece of developing new abuse deterrent products is having the necessary data on the impact of existing ADF products,” which is also an important consideration in taking any adverse action against certain generics. But there are other areas that perhaps deserve more attention, such as better education for healthcare providers, for instance, as Califf says “we need a much more robust national research effort to inform doctors and patients about the long-term benefits or risks associated with the use of opioids for treating chronic pain.” However, there is an enforcement element to controlling opioid abuse and those that prescribe them, but also developing a national database so that pharmacists and healthcare providers can see what other prescriptions patients are taking from other providers and in other jurisdictions. In my opinion, FDA should not be shortsighted with regards to controlling the number of opioid applications it approves, but rather on how best to assure that they are appropriately used. The entire problem cannot be tackled with a single swipe of a brush, nor can we expect to make progress in the war on drug abuse until there is a national policy that accurately and comprehensively addresses all of the tentacles of the problem. We need to take precautions to assure access, availability, and a reasonable national policy to deal with a problem that the nation has not been able to successfully address since the war on drugs began decades ago. |