首页 > 资讯 > FTC建议FDA重新考虑顺势治疗药物的监管制度

出自识林

2015-08-26

在2015年3月，FDA发布了一个通知，对现行顺势治疗药物使用、和FDA的监管方式征求意见。上周，联邦贸易委员会（Federal Trade Commission，FTC）已经向FDA递交了一个意见稿。联邦贸易委员会曾在2015年6月宣布，在9月份将举办一个研讨会，来讨论非处方药的顺势治疗药物的广告。

联邦贸易委员会的意见稿在内部以5票支持、0票反对通过。不足为奇的是，联邦贸易委员会的原则是，顺势治疗药物的声明必须有充足的、可靠的科学证据支持。意见稿显示，联邦贸易委员会认为，FDA允许顺势治疗药物不需要有效性证据就能上市，这一矛盾的政策破坏了联邦贸易委员会的原则。联邦贸易委员会人员表示，因为这一矛盾使得对顺势治疗药物采取行动是棘手的。

为解决FDA的政策和联邦贸易委员会的广告证实政策（advertising substantiation policy）之间的矛盾,联邦贸易委员会人员提出3个可行的方案：

1. FDA停止现行政策，并要求顺势治疗药物达到其它经典非处方药那样的标准；

2. FDA移除顺势治疗药物的适应症要求，这样，适应症的内容是自愿的；所以将不会被FDA处罚，而需要符合联邦贸易委员会的充足的可靠的科学证据标准。

3. FDA修订目前的政策，要求适应症应有充足的可靠的科学证据支持。

联邦贸易委员会人员的意见稿包括了两个研究（目标群体和复制的试验）的数据，来支持论点：消费者对顺势治疗药物的性质是不清楚的。这些研究及其解释，无疑会成为联邦贸易委员会9月研讨会的热门话题。

意见稿确定了联邦贸易委员会的目标是，坚持顺势治疗药物应该与经典药品有同样的标准。现在的问题是，FDA是接受委员会的建议并推进目标的实现，还是FDA继续认可顺势治疗药物的独特性。

Bob Pollock的评论：

FDA也计划在9月15日，举行公开研讨会，来听取关于顺势治疗药物广告的各方观点。

联邦贸易委员会的意见稿描述了“FDA的监管制度和联邦贸易委员会的广告证实政策的潜在矛盾”。联邦贸易委员会进行了公众对顺势治疗药物认知的研究，并总结认为“很多消费者不正确的认为，这些产品是经过FDA预批准的，并经过人体有效性检验的。在美国的零售商店，顺势治疗药物放在其它经过FDA预批准的、并经过人体有效性检验的药品旁边，这更增加了公众的认知混淆。最后，顺势治疗药物的标签是混淆性的，并不符合经典药品标签。一个消费者基于上述原因而选择使用顺势治疗药物，是会带来伤害的。联邦贸易委员会的人员认为FDA在讨论顺势治疗药物的监管制度时，应该考虑这些因素。”最后，他们陈述“因此，联邦贸易委员会人员建议FDA重新考虑顺势治疗药物的监管制度，来解决这些意见讨论的问题。”

这将会有怎样的走向？只有时间能回答。但是看来，已经到了FDA通过做出符合法规和监管原则的决定，来发挥实际作用的时候了，尤其是在当前环境下，把这些问题公之于众。

相关识林资讯，请查看你站在哪边？顺势药物的评论已经达到3500 2015-07-09。

编译：识林-榕
识林^TMwww.shilinx.com版权所有，未经许可不得转载。如需使用请联系admin@shilinx.com

参考原文：
1. FDA Law blog, FTC Staff Recommends That FDA Reconsider Its Regulatory Framework for Homeopathic Drug Products, 2015-08-23 url

As we previously reported, FDA and FTC are reviewing their regulation of homeopathic drugs. In March 2015, FDA issued a notice requesting comments on the current use of homeopathic drugs, and that agency’s approach to regulation of the category. In June 2015, FTC announced a workshop in September to discuss advertising of over-the-counter (OTC) homeopathic products.

Last week, FTC staff announced that it has submitted a comment to FDA. The comment was approved by the Commission by a vote of 5-0. Not surprisingly, FTC staff takes the position that claims for homeopathic drugs must be supported by competent and reliable scientific evidence. The comment suggests that FTC believes that its position is compromised by FDA’s current conflicting policy that allows marketing of homeopathic drug products without proof of efficacy. FTC staff suggests that it has been “reluctant” to pursue action against homeopathic products because of this conflict.

FTC staff puts forward three possible approaches for FDA to resolve the conflict between FDA’s policy and FTC’s substantiation doctrine:

1. FDA discontinues its current policy and requires that homeopathic products meet the same standard as other conventional OTC drug products;

2. FDA removes the requirement for an indication for homeopathic drug products so that the inclusion of the indication becomes voluntary and, therefore, is no longer “sanctioned” by FDA but remains subject to FTC’s standard of competent and reliable scientific evidence;

3. FDA amends the current policy to require that the indication be supported by “competent and reliable scientific evidence.”

The FTC staff’s comment includes data from two studies – a focus group and copy test – to support its contention that consumers are confused about the nature of homeopathic products. These studies and their interpretation will undoubtedly be a topic of discussion at FTC’s September workshop.

The comment confirms that FTC is intent on holding homeopathic drug products to the same standard as conventional drug products. The question now is whether FDA will accept the comment’s recommendations in furtherance of that objective or if FDA will continue to recognize the uniqueness of homeopathic drug products.

2. Bob Pollock's blog, FTC Weighs in on Homeopathic Drugs in Public Comment to Docket, 2015-08-24

The FDA is also planning a public workshop on September 15, 2015 to hear various views on the advertising of homeopathic products.

The FTC goes on to describe a “potential conflict between FDA’s regulatory framework and FTC’s advertising substantiation policy.” In research conducted by or for the FTC on the perception of homeopathic products they conclude that “(M)any consumers may incorrectly believe these products are pre-approved by the FDA and tested on humans for efficacy. To add to this confusion, homeopathic products are placed side-by-side in retail stores throughout the United States next to products that are actually pre-approved by the FDA and tested on humans for efficacy. Finally, homeopathic product labels are confusing and do not conform with conventional product labeling. A consumer’s choice to use homeopathic medicine based on the above factors could cause harm. The FTC staff believes that the FDA should take these factors into consideration in its review of the regulatory framework for homeopathic products.” And finally they state: “Accordingly, the FTC staff recommends that the FDA reconsider its regulatory framework for homeopathic medicines to address the concerns discussed in these comments.” The full text of the FTC comment can be found here.

Where will this go? Only time will tell, but it looks like the time has come for the FDA to make the rubber meet the road by making some decision consistent with the statutory and regulatory principles embodied in the legislation, especially in today’s environment, and putting this issue to bed once and for all.