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Worum geht es?
Liebe Patientinnen und Patienten, liebe Kolleginnen und Kollegen, liebe Heilpraktikerinnen und Heilpraktiker, liebe Apothekerinnen und Apotheker, liebe Unterstützende der Homöopathie,
in Deutschland wird das Aberkennen des Arzneimittelstaus von Homöopathika politisch vorbereitet. In den USA sind diese Bestrebungen bereits weiter fortgeschritten. Wir rufen Sie alle dazu auf, die Bevölkerung der USA bei ihrem Bestreben der Rettung der Homöopathika zu unterstützen. Diese bitten die FDA um eine Fristverlängerung von 180 Tagen zur Klärung offener Fragen.
Das Positive am internationalen Homöopathie-Bashing ist, dass sich die homöopathischen Community weltweit zunehmend zusammenschließt.
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Gemeinsam für eine starke und gesundende Gesellschaft.
Ulrike Fröhlich | Ärztin Dr. Elisabeth Häcker-Strobusch | Ärztin Hans Baitinger | Arzt
Textvorschlag zum Kopieren:
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As a supporter of Americans for Homeopathy Choice, I request that the FDA grant a 180-day extension to the Notice-and-Comment Period for this Draft Guidance. I and my fellow homeopathy supporters commend the FDA for listening to the homeopathy community and posting a revised Draft Guidance rather than finalizing the previous one. However, we believe that the revised guidance raises many new questions that require considerable clarification by parties interested in the regulation of homeopathy and therefore ask that additional time be granted in order to obtain that clarification.
Specifically, those areas needing clarification have been set out by Americans for Homeopathy Choice and include the following:
- The FDA claims that it has the authority to withdraw any and all generic name homeopathic medicines from the marketplace across all manufacturers without first proving that such medicines pose a danger to the public.
We understand “generic name homeopathic medicines” to mean substances diluted in accordance with homeopathic guidelines using diluents recognized as safe for such purposes such as sterile water, alcohol or glycerin so as to be nontoxic to humans and which are recognized by the Homeopathic Pharmacopoeia of the United States and its supplements. These generic name homeopathic medicines may be included in branded single medicine homeopathic products such as Chamomilla (chamomile) or included in products which contain more than one generic name homeopathic medicine, often called combination products.
- We would like the FDA to distinguish the claim of authority in item 1 from the FDA’s authority to withdraw manufacturer-branded, distributor-branded, and store-branded homeopathic products or lots thereof which are improperly manufactured and/or labeled. Improperly manufactured and/or labeled products claiming to be homeopathic may pose a danger to the public precisely because they do not meet homeopathic standards. We would like the FDA to comment on our belief that these improperly manufactured and/or labeled substances are the products that concern the FDA and would like a clarification from you about the accuracy of this belief.
We believe that the problems with these products may be because of their concentration, their labeling instructions or their purity or because they are mixed with active ingredients that are not recognized as homeopathic. Does the FDA, in fact, acknowledge 1) that the problem in these cases results from products that have been labeled as homeopathic but which are NOT homeopathic and 2) that any concerns reflect solely on the manufacturer, distributor or store and cannot be attributed to the generic name homeopathic medicines purported to be in the products? If not, why not?
- The FDA claims that homeopathic medicines are “new drugs” under the Food, Drug and Cosmetic Act of 1938 and its amendments. We would like more information on how the FDA arrived at this conclusion, particularly whether federal law states anywhere that homeopathic medicines are “new drugs.”
- The FDA claims that its risk-based approach to regulating homeopathic medicines will, in fact, reduce risk. We would like more information about how withdrawing nontoxic, inherently safe, properly manufactured and labeled homeopathic medicines would reduce risk to consumers who 1) gain benefit from them for various conditions and 2) more specifically, desire to treat illnesses and infections without risking antibiotic resistance and wish to treat pain without risking opioid dependence and death.
We would like more information on why the FDA believes it would reduce risk to consumers by focusing additional enforcement resources on properly manufactured and labeled homeopathic medicines (which are by design nontoxic and inherently safe) instead of on pharmaceuticals and medical devices which have inherent dangers even when they are properly manufactured and labeled.
Americans for Homeopathy Choice has asked for clarifications on these issues. We support obtaining clarifications on these points.
To allow enough time to obtain these clarifications, I once again ask the FDA to grant a 180-day extension to the Notice-and-Comment Period for this Draft Guidance.