{"id":8011,"date":"2019-09-20T18:05:40","date_gmt":"2019-09-20T22:05:40","guid":{"rendered":"https:\/\/iseai.org\/?p=8011"},"modified":"2022-11-15T11:28:27","modified_gmt":"2022-11-15T16:28:27","slug":"vip","status":"publish","type":"post","link":"https:\/\/iseai.org\/vip\/","title":{"rendered":"Vasoactive Intestinal Peptide (VIP) FDA Review"},"content":{"rendered":"

By Lori Allen, RPh, ISEAI Board Director, owner of Mixtures Pharmacy<\/a><\/p>\n

We ask you to explain to the FDA why it is important for you to have continued access to compounded intranasal Vasoactive Intestinal Peptide (VIP).<\/strong><\/p>\n

The FDA is reviewing the status of VIP. They are accepting comments<\/a> on regulations.gov through December 5th<\/sup>, 2019 and will then decide to:<\/p>\n

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  1. Have a hearing, or<\/li>\n
  2. Make recently proposed rules a law and effectively remove VIP from our list of available products to compound<\/em><\/li>\n<\/ol>\n

    [Use this link<\/a> to directly send your comments to the FDA before December 5th<\/sup>, 2019.]<\/strong><\/p>\n

    You can copy the text below and paste it into the comments box:<\/em><\/p>\n

    \n

    To Whom it May Concern:<\/p>\n

    I currently use compounded intranasal VIP to help me (fill in why you use it – to function, not have brain fog, keep a job, spend time with my family, etc)<\/em><\/strong><\/p>\n

    Without VIP, I feel (tell them how you feel – horrible, depressed, mentally foggy, unable to function, etc)<\/strong>.<\/em><\/p>\n

    Without VIP my ability to function (let them know the impact of not having access to VIP – is severely limited, is marginal, would prevent me from holding a job, might put me on disability, etc)<\/strong><\/em><\/p>\n

    (Add more of your story here)<\/em><\/strong><\/p>\n

    Please reconsider keeping compounded intranasal VIP accessible to me, because of the positive impact it makes on my life.<\/p>\n<\/blockquote>\n

    Some history:<\/strong> The FDA\u2019s Pharmacy Compounding Advisory Committee (PCAC) met back in 2016 and decided at that time there wasn\u2019t enough information for them to move VIP from the Category 1 List, a list that was safe for the patient and available for compounding pharmacies to use, to the positive Bulk Substances List. On 9\/15\/19 the FDA released new rules (PDF<\/a>).<\/p>\n

    About VIP<\/h3>\n

    Vasoactive Intestinal Peptide (VIP) is considered a major regulatory peptide<\/em> in the brains of mammals. It acts as a neurotransmitter or immunomodulator in not only the brain but in the heart, lung, pancreas, thyroid, genitourinary tract and the immune system.<\/p>\n

    VIP is made up from amino acids (28 to be exact). It belongs in the family of glucogon\/secretin peptides which do a lot to control the hypothalamus-pituitary-adrenal (HPA) axis, and the endocrine system. While it was initially discovered in the small intestine, it is also produced throughout the body; in a tiny part of the hypothalamus called the suprachiasmatic nuclei (SCN, see image below<\/em>), in the pancreas, as well as synthesized in the immune cells and the endocrine cells.<\/p>\n

    VIP’s actions are widespread and it is found in both the central and peripheral nervous systems.<\/p>\n

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    Some of the more direct actions we see with VIP include stimulating contractility<\/a>\u00a0in the heart, causing\u00a0vasodilation<\/a>, increasing\u00a0glycogenolysis<\/a>, lowering arterial\u00a0blood pressure<\/a>\u00a0and relaxing the smooth muscle of\u00a0trachea<\/a>, stomach and\u00a0gall bladder<\/a>.<\/p>\n<\/blockquote>\n

    \"\"

    VIP works with the SCN to regulate the circadian system by synchronizing cues from light<\/p><\/div>\n

    Research on VIP<\/h3>\n

    Research has identified the many diverse roles of VIP, including:<\/p>\n