{"id":1654904,"date":"2022-09-23T09:08:40","date_gmt":"2022-09-23T13:08:40","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1654904"},"modified":"2022-09-23T09:08:47","modified_gmt":"2022-09-23T13:08:47","slug":"dvorah-richman-taking-one-step-forward-and-two-back","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/dvorah-richman-taking-one-step-forward-and-two-back\/","title":{"rendered":"Dvorah Richman: Taking One Step Forward and Two Back"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"float:left\"><div class=\"counts mashsbcount\">18<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fdvorah-richman-taking-one-step-forward-and-two-back%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1654904&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><div><\/div>\n<aside id=\"aside1\" class=\"left aside-wrapper aside-wrapper-950\">\n<\/aside>\n<p>During a recent 60 Minutes interview, President Biden declared that the Covid pandemic \u201cis over.\u201d However, the president\u2019s own senior health officials quickly noted that hundreds of people are still dying every day, and the virus is still able to evolve into new variants that will \u201cdefy standard public health mechanisms for addressing an outbreak.\u201d\u00a0<\/p>\n<p>Moreover, it\u2019s expected that the Department of Health and Human Services (HHS)) will renew its public health emergency declaration past the current October 13 deadline.\u00a0<\/p>\n<p>The COVID-19 pandemic has caused untold human suffering, significantly impaired children\u2019s learning, inflicted extensive economic damage, and put enormous pressure and stress on our nation\u2019s healthcare infrastructure.\u00a0<\/p>\n<p>While extending the public health emergency raises many complicated and controversial issues, one of the bright spots of the federal emergency response has been agencies granting federal \u201cflexibilities\u201d in law and policy, thus reducing government delays and red tape.\u00a0<\/p>\n<p>Most people are probably familiar with the relatively easy availability of telehealth during the pandemic. Today, many states have made flexibilities around telehealth permanent.\u00a0<\/p>\n<p>However, many more temporary policies should be considered for permanent status.\u00a0<\/p>\n<p>For example, the U.S. Food and Drug Administration (FDA) temporarily allowed marketing of medical devices that had not undergone FDA\u2019s premarket process \u2013 so long as manufacturers adhered to various clearly articulated requirements. Manufacturers could also market devices for new or different populations, such as pediatric patients, and make \u201climited\u201d modifications to FDA-cleared devices, without getting additional FDA approval.\u00a0<\/p>\n<p>These flexibilities were aimed at manufacturers of medical devices critically needed during the crisis. The government\u2019s temporary \u201cenforcement discretion\u201d provided much-needed solutions to serious problems, including device shortages, manufacturing and supply chain issues, and exposure to diseases.\u00a0<\/p>\n<p>It was clearly the correct policy to make it easier and faster to bring vital products to frontline workers and patients during the pandemic \u2013 including personal protective equipment, ventilators, infusion pumps, non-invasive remote patient monitoring devices, respirators, and non-invasive fetal and maternal monitors and imaging devices.\u00a0<\/p>\n<p>But good policy during a pandemic can also be good policy all the time.\u00a0<\/p>\n<p>As we enter the \u201cnew normal,\u201d many of these temporary changes should be made permanent \u2013 thereby maintaining the nation\u2019s nimbleness in responding to rapidly changing circumstances, while continuing to balance risks and benefits appropriately.\u00a0<\/p>\n<p>Unfortunately, FDA anticipates <em>revoking<\/em> flexibilities and returning to \u201cnormal operations.\u201d Per FDA draft guidance regarding transition plans for Covid-19 related medical devices, once flexibilities are withdrawn, the same manufacturers whose products are now available would only have 180 days to meet the \u201cregular\u201d FDA requirements.\u00a0<\/p>\n<p>This would this impose enormous time pressure on manufacturers, who will have to navigate sometimes confusing government bureaucracy. Further, the same manufacturers whose products are available today could be subject to <em>civil and criminal penalties<\/em> for failing to comply with the \u201cregular\u201d rules and policies.\u00a0<\/p>\n<p>To cite just one example, in order to continue marketing a product, manufacturers may need to collect performance data \u2013 test results from engineering and bench testing, design verification, human factors testing, animal testing and even clinical studies \u2013 before they will meet the revived FDA requirements. \u00a0<\/p>\n<p>Depending on various circumstances, it may not be possible to collect, analyze and provide the needed data to FDA within the time provided. That would leave manufacturers, as well as healthcare providers and patients, in a lurch.\u00a0<\/p>\n<p>There\u2019s little question that FDA\u2019s regulatory flexibilities have led to silver linings during the pandemic: limiting disease exposure via remote patient monitoring; reducing use of hospital beds and other scarce resources; developing new technologies; providing cost savings to patients and industry; and allowing FDA to focus on higher risk products and issues.\u00a0<\/p>\n<p>That is why going back to \u201cnormal operations\u201d would be taking two steps back after making such important progress at a time when that progress was needed most.\u00a0<\/p>\n<p>Any \u201cnew normal\u201d should retain and build upon these flexibilities, not scuttle them.\u00a0<\/p>\n<p>Doctors, patients, hospitals and elected officials should send that message to the FDA.\u00a0<\/p>\n<p><em>Dvorah A. Richman has practiced regulatory law for more than 35 years.She is currently in private practice, and has been in-house regulatory counsel to large, international medical device companies.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>During a recent 60 Minutes interview, President Biden declared that the Covid pandemic \u201cis over.\u201d However, the president\u2019s own senior health officials quickly noted that hundreds of people<\/p>\n","protected":false},"author":1,"featured_media":1654906,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-1654904","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1654904","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1654904"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1654904\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/1654906"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1654904"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1654904"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1654904"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}