1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/Comments Concerning Disclosure of Information on Investigational Products - Public Citizenrich600338<blockquote class="wp-embedded-content" data-secret="UHcSW6uxRN"><a href="https://www.citizen.org/article/comments-concerning-disclosure-of-information-on-investigational-products/">Comments Concerning Disclosure of Information on Investigational Products</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/comments-concerning-disclosure-of-information-on-investigational-products/embed/#?secret=UHcSW6uxRN" width="600" height="338" title="“Comments Concerning Disclosure of Information on Investigational Products” — Public Citizen" data-secret="UHcSW6uxRN" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript">
/* <![CDATA[ */
/*! This file is auto-generated */
!function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document);
/* ]]> */
</script>
Unfortunately, the FDA has chosen to limit its proposal for disclosure to only two interventions: 1.) gene therapy; and 2.) the transplantation of non-human tissue to human beings (xenotransplantation). Regrettably, this proposed rule as it applies to gene therapy follows the practice of the National Institutes of Health's (NIH) Recombinant DNA Advisory Committee (RAC) established 20 years ago. The FDA proposed rule is a long overdue attempt to harmonize its policy with that of the NIH.https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628