{"id":1137,"date":"2022-04-13T01:27:38","date_gmt":"2022-04-13T05:27:38","guid":{"rendered":"https:\/\/herpescureadvocacy.com\/?p=1137"},"modified":"2022-04-13T01:30:24","modified_gmt":"2022-04-13T05:30:24","slug":"request-a-patient-listening-session-at-the-fda","status":"publish","type":"post","link":"https:\/\/herpescureadvocacy.com\/2022\/04\/13\/request-a-patient-listening-session-at-the-fda\/","title":{"rendered":"Request a Patient Listening Session at the FDA"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"1139\" data-permalink=\"https:\/\/herpescureadvocacy.com\/2022\/04\/13\/request-a-patient-listening-session-at-the-fda\/pexels-photo-1181406\/\" data-orig-file=\"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?fit=1880%2C1255&amp;ssl=1\" data-orig-size=\"1880,1255\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;&quot;,&quot;orientation&quot;:&quot;0&quot;}\" data-image-title=\"group of people on a conference room\" data-image-description=\"\" data-image-caption=\"&lt;p&gt;Photo by Christina Morillo on &lt;a href=&quot;https:\/\/www.pexels.com\/photo\/group-of-people-on-a-conference-room-1181406\/&quot; rel=&quot;nofollow&quot;&gt;Pexels.com&lt;\/a&gt;&lt;\/p&gt;\n\" data-large-file=\"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?fit=750%2C501&amp;ssl=1\" src=\"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?resize=492%2C328&#038;ssl=1\" alt=\"\" class=\"wp-image-1139\" width=\"492\" height=\"328\" \/><\/figure>\n<\/div>\n\n\n<div style=\"height:53px;\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Hi there Herpes Advocates, we&#8217;re happy you&#8217;re here. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Advocacy Alert: Request a Patient Listening Session at the FDA<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The landscape for prevention of HSV in America is inadequate. There is a critical loophole without an accurate test to diagnose asymptomatic infection. Currently available FDA-approved tests for HSV are inaccurate 50% of the time with confirmatory testing. As a result clinical care, and public health outcomes are suffering. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">With only these sub-optimal diagnostic tools in our diagnostic toolkit, Americans are lead to believe they are HSV+ when they are not, or that they are HSV- when they have the infection. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We need your help to tell the FDA: We want a patient listening session to discuss the sub-optimal diagnostic serology tests that they have approved. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Step 1: Fill out <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/email\/dsp_ESMR.cfm\">this form<\/a> to request a patient listening session. <\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Answers to Form fields:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Patient Group<\/strong>: Herpes Cure Advocacy<\/li><li><strong>Question or Meeting<\/strong>: Meeting<\/li><li><strong>What is your request about<\/strong>? A Medical Device<\/li><li><strong>Is your request about a specific FDA Program<\/strong>: Yes, Patient Listening Session<\/li><li><strong>Name or condition<\/strong>: Herpes Simplex Virus <\/li><li><strong>Question<\/strong>: Diagnostic Tests have sub-optimal results, and are wrong 50% of the time. This is leading to many false +\/- results and is impacting public health outcomes dramatically. Please schedule a patient listening session so that the impacts of the sub-optimal tests, both on patients health and wellbeing, and impacts to prevention of HSV from a public health perspective can be discussed. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Step 2: Email the FDA HSV Diagnostics Team<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Please email all of the following people, and copy <a href=\"mailto:info@herpescureadvocacy.com\">info@herpescureadvocacy.com<\/a>:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"mailto:CDRH_PatientEngagement@fda.hhs.gov\">CDRH_PatientEngagement@fda.hhs.gov<\/a>, <a href=\"patientaffairs@fda.hhs.gov\">patientaffairs@fda.hhs.gov, <\/a><a href=\"mailto:Maria.Garcia@fda.hhs.gov\">Maria.Garcia@fda.hhs.gov<\/a>, <a href=\"mailto:Kathleen.Whitaker@fda.hhs.gov\">Kathleen.Whitaker@fda.hhs.gov<\/a>, <a href=\"mailto:Eva.Rorer@fda.hhs.gov\">Eva.Rorer@fda.hhs.gov<\/a>, <a href=\"Laura.Ulitzky@fda.hhs.gov\">Laura.Ulitzky@fda.hhs.gov, <\/a><a href=\"Ryan.Karsner@fda.hhs.gov\">Ryan.Karsner@fda.hhs.gov, <\/a><a href=\"mailto:Himani.Bisht@fda.hhs.gov\">Himani.Bisht@fda.hhs.gov<\/a><br><a href=\"Kathryn.Capanna@fda.hhs.gov\">Kathryn.Capanna@fda.hhs.gov <\/a>, <a rel=\"noreferrer noopener\" href=\"mailto:tracy.gray@fda.hhs.gov\" target=\"_blank\">tracy.gray@fda.hhs.gov<\/a>, <a href=\"mailto:Michelle.Tarver@fda.hhs.gov\">Michelle.Tarver@fda.hhs.gov<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SUBJECT LINE:<\/strong> Please Schedule a Patient Listening Session to Discuss Health Outcomes w\/Sub-Optimal FDA-Approved HSV Diagnostic Tests<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SUGGESTED<\/strong> <strong>EMAIL CONTENT: <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dear Dr. Maria Garcia Ines and team, I have today submitted <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/email\/dsp_ESMR.cfm\">this form<\/a> to request a patient listening session to discuss patients experiences with the sub-optimal results from FDA-approved tests for Herpes Simplex Virus. Currently available tests are proven wrong 50% of the time with confirmatory testing. This is a critical problem in our public health interventions for HSV that needs to be addressed urgently &#8211; we should have better standards for our public health interventions and diagnostic tools! <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Many reports of inaccurate tests have been filed with the FDA already and studies have been shared documenting the sub-optimal results. Also, please review\u00a0<a rel=\"noreferrer noopener\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/28876290\/\" target=\"_blank\">this study.<\/a> and please review t<a rel=\"noreferrer noopener\" href=\"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S073288931930570X?via%3Dihub\" target=\"_blank\">his study.<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Please prioritize the health of American people, by taking the time to schedule a listening session so that you can hear and understand the severe impacts to patients lives first hand. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Feel free to add any of your own personal story with HSV testing that is relevant.<\/em> <\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n","protected":false},"excerpt":{"rendered":"<p>Hi there Herpes Advocates, we&#8217;re happy you&#8217;re here. Advocacy Alert: Request a Patient Listening Session at the FDA The landscape for prevention of HSV in America is inadequate. There is<a class=\"more-link\" href=\"https:\/\/herpescureadvocacy.com\/2022\/04\/13\/request-a-patient-listening-session-at-the-fda\/\">Continue reading <span class=\"screen-reader-text\">&#8220;Request a Patient Listening Session at the FDA&#8221;<\/span><\/a><\/p>\n","protected":false},"author":205069572,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"{title}\n\n{excerpt}\n\n{url}","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"_wpas_customize_per_network":false,"jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-1137","post","type-post","status-publish","format-standard","hentry","category-uncategorized","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Request a Patient Listening Session at the FDA - Herpes Cure Advocacy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/herpescureadvocacy.com\/2022\/04\/13\/request-a-patient-listening-session-at-the-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Request a Patient Listening Session at the FDA - Herpes Cure Advocacy\" \/>\n<meta property=\"og:description\" content=\"Hi there Herpes Advocates, we&#8217;re happy you&#8217;re here. 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Advocacy Alert: Request a Patient Listening Session at the FDA The landscape for prevention of HSV in America is inadequate. 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Therefore, the goal of\u2026","rel":"","context":"With 1 comment","block_context":{"text":"With 1 comment","link":"https:\/\/herpescureadvocacy.com\/2023\/01\/07\/cdc-issues-request-for-proposal-to-develop-new-serology-test-for-herpes-simplex-virus\/#comments"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":491,"url":"https:\/\/herpescureadvocacy.com\/2021\/10\/27\/advocacy-at-the-fda-for-herpes\/","url_meta":{"origin":1137,"position":1},"title":"How to Advocate the FDA for Accurate Herpes Testing","author":"Patient Advocate","date":"October 27, 2021","format":false,"excerpt":"Why do we need advocacy at the FDA? Because any Herpes Simplex Virus prevention strategy in the US is incomplete without an accurate diagnostic test. There is currently NO FDA-approved accurate diagnostic serology test (what we need to diagnose asymptomatic infection) on the market. With a virus that is primarily\u2026","rel":"","context":"In &quot;Advocacy&quot;","block_context":{"text":"Advocacy","link":"https:\/\/herpescureadvocacy.com\/category\/advocacy\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/11\/pexels-photo-954585.jpeg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/11\/pexels-photo-954585.jpeg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/11\/pexels-photo-954585.jpeg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/11\/pexels-photo-954585.jpeg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/11\/pexels-photo-954585.jpeg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/11\/pexels-photo-954585.jpeg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":1742,"url":"https:\/\/herpescureadvocacy.com\/2021\/12\/28\/key-stakeholders-for-herpes-patient-advocacy\/","url_meta":{"origin":1137,"position":2},"title":"Key Stakeholders for Herpes Patient Advocacy","author":"Patient Advocate","date":"December 28, 2021","format":false,"excerpt":"USE YOUR VOICE FOR CHANGE How long until a herpes cure? When asking this question - ask yourself, what can I do to help? Want to know when the next clinical trial for a herpes cure is? Contact your elected representatives - tell them we need more clinical research for\u2026","rel":"","context":"In &quot;Advocacy&quot;","block_context":{"text":"Advocacy","link":"https:\/\/herpescureadvocacy.com\/category\/advocacy\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":1297,"url":"https:\/\/herpescureadvocacy.com\/2022\/06\/29\/possible-herpes-keratitis-cure-takes-another-step-bdgene-of-china-applies-for-orphan-drug-designation-at-the-fda\/","url_meta":{"origin":1137,"position":3},"title":"Possible herpes keratitis cure takes another step: BDGene of China applies for Orphan Drug Designation at the FDA","author":"Patient Advocate","date":"June 29, 2022","format":false,"excerpt":"Chinese company BDGene from Shanghai continues to lead in the global race for a herpes keratitis cure. The highly anticipated treatment, BD111 has reached a big milestone as it applied for Orphan Drug designation from the US FDA. Previously, BD111 has received international attention for its progress with a gene\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":4396,"url":"https:\/\/herpescureadvocacy.com\/2024\/08\/18\/hsv-herpes-testing-diagnosis-treatment\/","url_meta":{"origin":1137,"position":4},"title":"Genital Herpes: Diagnosis, Testing, Treatment","author":"Patient Advocate","date":"August 18, 2024","format":false,"excerpt":"Johnston C, Wald A. Genital Herpes. JAMA. 2024;332(10):835\u2013836. doi:10.1001\/jama.2024.12743 Outstanding up-to-date summary of the genital herpes virus, symptoms, testing, and treatment by two of the world\u2019s leading herpes researchers and experts. 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