MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

The FDA just made the following significant announcement:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

Date

April 20-21, 2015

Time

9:00 am to 4:00 pm

Location

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993

Attendance, Registration, and Oral Presentations

Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.

Webcast Information

If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation

Agenda

The agenda will be posted soon

And this is what Reuters reported about the planned event:

The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.

In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.

9 Responses to The FDA is about to assess homeopathy

  • I hope this will turn good for science !

  • I may be missing something, but I’m not clear from this article on exactly how to make my input heard. Will you be posting about that in the near future?

  • Sadly, the FDA passed Breast thermography on the basis that it doesn’t directly cause harm, though we know the harm of these useless devices and/or treatments is in that they’re useless. In 2011 they added a statement cautioning that it wasn’t a substitute for mammo, but thermography retains its FDA approval. I’m not all that optimistic.

  • Homeopathy medicine is nothing more than water and/or sugar pills. If anyone has experienced anything good from a homeopathic drug, it was due to a placebo affect. It is a waiste of money and ripping off the ignorant public.

  • Let us just hope that the FDA does not somehow inadvertently ‘legitimize’ homeopathy by giving it this ‘airing’. One of the big issues, as you well know, about the vaccine “debate” is that we are allowing it to get framed as a debate when there is none. Framing homeopathy as a legitimate ‘debate’ is not helpful in the long run.

    This excellent article by André Picard in Canada’s Globe and Mail today is on exactly this topic and is worth a read:

    http://www.theglobeandmail.com/globe-debate/were-aiding-and-abetting-homeopathic-quackery/article23701139/

    • Decades of growing Naturopathic Medicine approach worldwide has produced many thousands of patient case successes. When I meet these patients myself I usually hear a story that started with visits to orthodox practitioners and specialists. It’s those cases that don’t get helped there that continue to explore. Naturopathy is often a second choice because of how we are raised in the west, Dr Kildare and Grey’s Anatomy etc. The fiscal models in healthcare actively discourage these choices. Those who are staying in these therapies would only be doing so if they are seeing real improvements. Patients tell me about the merry-go-round – then they get to the most common thread in their stories “… a friend told me to check out a natural medicine clinic and then finally things started to change for me.” Homeopathy is just one of many important tools in that toolbox. Everything I see tells me the modality remains one of the safest remedy systems in use worldwide. Also, doing a telephone consumer survey as a means to calculate a market of $3B sounds like bunk to me – an attempt to remove the big guys/ small guys factor. I don’t think it is even 25% of that estimate. Affluent smart educated very sick patients who have the ability to pick from specialists around the world are eventually turning to these natural medicine approaches because they are producing extraordinary results. We need more investment in developing these technologies, not more of the same old same old. On the positive note – nobody is forcing people to attend a natural med clinic. Fortunately there is still Freedom to Choose for yourself and when you need it, it will be there.

      • T Cotter said:

        Decades of growing Naturopathic Medicine approach worldwide has produced many thousands of patient case successes.

        No, all we can say is that naturopaths have produced thousands of patient cases.

        You might like to read this account of one naturopath who realised she was being conned: Naturopathic Diaries

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

If you want to be able to edit your comment for five minutes after you first submit it, you will need to tick the box: “Save my name, email, and website in this browser for the next time I comment.”
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories