{"id":188259,"date":"2021-08-05T11:13:01","date_gmt":"2021-08-05T15:13:01","guid":{"rendered":"https:\/\/z3news.com\/w\/?p=188259"},"modified":"2021-08-06T11:19:37","modified_gmt":"2021-08-06T15:19:37","slug":"pressure-congress-on-homeopathy","status":"publish","type":"post","link":"https:\/\/z3news.com\/w\/pressure-congress-on-homeopathy\/","title":{"rendered":"Pressure Congress on Homeopathy"},"content":{"rendered":"
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Help us build support in Congress to save homeopathy from the FDA\u2019s overreach. Action Alert!<\/a><\/strong><\/p>\n

We\u2019ve been telling you over the last few years about the recent FDA guidance<\/strong><\/a> that threatens the future of homeopathic medicines in the US. Upending decades of safe regulation, FDA released a draft guidance in 2017 that essentially stated that all homeopathic drugs are illegal. ANH-USA, our friends at Americans for Homeopathy Choice, and other stakeholders are working with Representative Ro Khanna (D-CA) to get members of Congress to sign on to a letter to the FDA clarifying how the agency will ensure continued access to important homeopathic medicines. Take action below to urge your member of Congress to support this important initiative!<\/p>\n

To recap, the FDA\u2019s\u00a0guidance document, which lays out the agency\u2019s current position on the regulation of homeopathic drugs, says:<\/p>\n

    \n
  1. Any homeopathic drug that has not been considered \u201cgenerally recognized as safe and effective\u201d (GRAS\/E) is considered a new drug;<\/li>\n
  2. FDA has not determined that\u00a0any homeopathic drugs are GRAS\/E;<\/li>\n
  3. A new drug cannot be marketed unless it goes through the FDA\u2019s approval process;<\/li>\n
  4. No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.<\/li>\n<\/ol>\n

    The guidance also explains that, while all homeopathic drugs are illegal, the FDA will apply a risk-based enforcement approach. The agency has already begun to apply this doctrine; earlier this year the agency\u00a0attacked<\/strong><\/a>\u00a0manufacturers of injectable homeopathic medicines.<\/p>\n

    We know this isn\u2019t about safety. A\u00a0review<\/strong><\/a>\u00a0<\/strong>of the evidence of adverse events related to homeopathy, which included data from 12 European countries, the US, Mexico, India, Israel and Brazil published between 1978 and 2010, found a total of just 1,159 adverse events. This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. Worldwide, an estimated\u00a0200 million people<\/strong><\/a>\u00a0use homeopathy regularly, including 6 million in the United States. These data show that adverse events from homeopathic medicines occur at a very, very low rate.<\/p>\n

    So why go after homeopathic medicines? The FDA gets a large part of its funding from drug company user fees, and for this reason sees Big Pharma as its client. Homeopathic medicines, like supplements and other natural products, compete with pharmaceutical drugs, so the FDA uses its enormous power to tilt the scales in favor of the drug companies.<\/p>\n

    We must protect homeopathy from the FDA\u2019s attempt to destroy it.<\/p>\n

    Action Alert! <\/strong>Write to your member of Congress and urge them to sign on to Rep. Khanna\u2019s letter to the FDA. Please send your message immediately.<\/strong><\/p>\n

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    \"\"<\/a><\/figure>\n<\/div>\n
    \n

    Share This Post<\/p>\n

    \n

    This post was originally published by\u00a0anh-usa.org<\/a>.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Help us build support in Congress to save homeopathy from the FDA\u2019s overreach. Action Alert!
    \nWe\u2019ve been telling you over the last few years about the recent FDA guidance that threatens the future of homeopathic medicines in the US. Upending decades of safe regulation, FDA released a draft guidance in 2017 that essentially stated that all homeopathic drugs are illegal. ANH-USA, our friends at Americans for Homeopathy Choice, and other stakeholders are working with Representative Ro Khanna (D-CA) to get members of Congress to sign on to a letter to the FDA clarifying how the agency will ensure continued access to important homeopathic medicines. Take action below to urge your member of Congress to support this important initiative!
    \nTo recap, the FDA\u2019s\u00a0guidance document, which lays out the agency\u2019s current position on the regulation of homeopathic drugs, says:
    \nAny homeopathic drug that has not been considered \u201cgenerally recognized as safe and effective\u201d (GRAS\/E) is considered a new drug;FDA has not determined that\u00a0any homeopathic drugs are GRAS\/E;A new drug cannot be marketed unless it goes through the FDA\u2019s approval process;No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.
    \nThe guidance also explains that, while all homeopathic drugs are illegal, the FDA will apply a risk-based enforcement approach. The agency has already begun to apply this doctrine; earlier this year the agency\u00a0attacked\u00a0manufacturers of injectable homeopathic medicines.
    \nWe know this isn\u2019t about safety. A\u00a0review\u00a0of the evidence of adverse events related to homeopathy, which included data from 12 European countries, the US, Mexico, India, Israel and Brazil published between 1978 and 2010, found a total of just 1,159 adverse events. This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. Worldwide, an estimated\u00a0200 million people\u00a0use homeopathy regularly, including 6 million in the United States. These data show that adverse events from homeopathic medicines occur at a very, very low rate.
    \nSo why go after homeopathic medicines? The FDA gets a large part of its funding from drug company user fees, and for this reason sees Big Pharma as its client. Homeopathic medicines, like supplements and other natural products, compete with pharmaceutical drugs, so the FDA uses its enormous power to tilt the scales in favor of the drug companies.
    \nWe must protect homeopathy from the FDA\u2019s attempt to destroy it.
    \nAction Alert! Write to your member of Congress and urge them to sign on to Rep. Khanna\u2019s letter to the FDA. Please send your message immediately.<\/p>\n

    Share This Post<\/p>\n","protected":false},"author":773,"featured_media":184034,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"sfsi_plus_gutenberg_text_before_share":"","sfsi_plus_gutenberg_show_text_before_share":"","sfsi_plus_gutenberg_icon_type":"","sfsi_plus_gutenberg_icon_alignemt":"","sfsi_plus_gutenburg_max_per_row":"","_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":"","_ppma_block_editor_authors":""},"categories":[359,364],"tags":[],"ppma_author":[1001],"class_list":["post-188259","post","type-post","status-publish","format-standard","has-post-thumbnail","category-fda","category-misguided-medicine","entry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t