《CPG Sec. 400.400 顺势治疗药物可以上市的条件》给出了顺势治疗药物的定义：.顺势治疗药物就是美国顺势治疗药典上声明为顺势的药物。顺势治疗成分与非顺势治疗活性成分的混合，不能称为顺势治疗药物。可以这样理解，目前大家接受的西医药多采用对抗疗法（allopathic），针对疾病通路进行阻断、减小阻断。而顺势治疗与此相反，是造成相同的症状来治愈疾病。
美国顺势治疗药典（The Homœopathic Pharmacopœia of the United States，HPUS），是独立的一部药典，是FD&CA 201中认可的官方纲要（与USP、NF法律定位相同）。HPUS书内容有：HPUS药物标准、临床确认指南、专论、顺势药物GMP等。第一版是1841年，第八版是1979年，1982年有了增补版。2013年，药典新公布了47个顺势治疗药物品种。美国顺势治疗药典会（Homoeopathic Pharmacopoeia Convention of the United States，HPCUS）有规程手册（Procedure Manual），包含了专论批准、会议、药典修订的章程。
Lachman CONSULTANTS - Bob Pollock先生
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
What Side Are You On? Homeopathic Drugs Comments Top 3500
By Bob Pollock | June 12, 2015 | Compliance, FDA, Regulatory Affairs, Science & Technology | Like |
On March 26, 2015, we blogged about an April 20-21 FDA Public Hearing regarding examining the need for the drug enforcement policy surrounding homeopathic drugs (here). Since the conclusion of that hearing, just under 3500 comments have been received from FDA.
Not surprisingly the comments relative to homeopathic products range from “they are the greatest thing since sliced bread” to “sheer quackery”. Until there are definitive studies on the products, no one will know for sure, but that does not mean there are lots of highly charged opinions. All of the comments can be viewed at the docket at Regulations.gov (here).
If you don’t have time to review each of the 3500 comments submitted thus far, I will provide some representative comments from the general public below. Remember, I am not taking sides here as I like to make decisions based on scientific fact, but I will say, as a pharmacist and former regulator, I remain a bit skeptical of the efficacy of homeopathic products. Anyway, here are a few of the most recent comments that span the range discussed above:
Homeopathy is NOT medicine, it is water that triggers a placebo response. I am sorry that the FDA must waste its time doing a review of this quackery, but I guess gullible people vote, and write their Congressional representatives. For an overview, see http://www.homeowatch.org/research/overview.html.
If it’s truly “safe and trusted”, it should be no problem to regulate its use. It may be safe in certain doses, but not in others. Without proper regulation safe dosage won’t be enforced and it could be a health hazard. Homeopathic medicine should play by the same rules as regular western medicine.
I think it is important to regulate homeopathic medicines to ensure that people understand that the benefit of these so called medicines are limited. Also, it is important that what is on the label is actually what is in the product that is being consumed.
I’m only in favor of this if it leads to the banning of homeopathic drugs because they are less than useless.
I have a very positive attitude about access to over-the-counter homeopathic medicines!
I am able to make informed decisions about purchasing homeopathic products vs. traditional OTC medications! I want to be able find the right medicine for my symptoms in the appropriate category area of the store! Being able to choose my own homeopathic treatment remedy is very important to me. I can treat many of my own symptoms myself in the early stages, which prevents most illnesses from getting serious enough to seek additional professional help.
I don’t understand why we have to keep having this conversation about Homeopathic medicines. Homeopathic medicines played a successful and major role in healing people during the formative years of our country, even before the advent of antibiotics. Homeopathics simply do no harm if you fail to choose the right remedy. So, they are fail-safe, which cannot be said for any of the allopathic OTC remedies. Homeopathics should be readily available in stores to anyone who chooses to use them.
I have used homeopathic products for over 40 years, they are very effective and have no side effects, no drug interactions, they go back way further than most conventional chemical medications, and they have been tested and used in many country’s for a long time, the decision to use them should be up to us not the pharmaceutical companies, we don’t need to be protected from great and at least harmless products, but we should be protected from pharmaceutical companies greed.
So there you have it. The spectrum of beliefs is wide and the love or hate of these products has been hotly contested ever since I can remember. Perhaps the FDA will take a step to decide the validity of the principles of use of such products, move to regulate them in some other manner, or perhaps the status quo will be maintained. But until the question of whether these products actually work, there will continue to be people that swear by them and those that swear at them!
