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