Request a Patient Listening Session at the FDA

Hi there Herpes Advocates, we’re happy you’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 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.

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.

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.

Step 1: Fill out this form to request a patient listening session.

Answers to Form fields:

  • Patient Group: Herpes Cure Advocacy
  • Question or Meeting: Meeting
  • What is your request about? A Medical Device
  • Is your request about a specific FDA Program: Yes, Patient Listening Session
  • Name or condition: Herpes Simplex Virus
  • Question: 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.

Step 2: Email the FDA HSV Diagnostics Team

Please email all of the following people, and copy info@herpescureadvocacy.com:

CDRH_PatientEngagement@fda.hhs.gov, patientaffairs@fda.hhs.gov, Maria.Garcia@fda.hhs.gov, Kathleen.Whitaker@fda.hhs.gov, Eva.Rorer@fda.hhs.gov, Laura.Ulitzky@fda.hhs.gov, Ryan.Karsner@fda.hhs.gov, Himani.Bisht@fda.hhs.gov
Kathryn.Capanna@fda.hhs.gov , tracy.gray@fda.hhs.gov, Michelle.Tarver@fda.hhs.gov

SUBJECT LINE: Please Schedule a Patient Listening Session to Discuss Health Outcomes w/Sub-Optimal FDA-Approved HSV Diagnostic Tests

SUGGESTED EMAIL CONTENT:

Dear Dr. Maria Garcia Ines and team, I have today submitted this form 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 – we should have better standards for our public health interventions and diagnostic tools!

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 this study. and please review this study.

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.

Feel free to add any of your own personal story with HSV testing that is relevant.



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