In September, Tidmarsh went after Tang\u2019s Aurinia and its drug voclosporin that treats lupus nephritis, a disease in which the immune system attacks the kidneys. In a startling post on his LinkedIn account, Tidmarsh claimed that the FDA-approved drug had not been shown to provide \u201chard\u201d clinical benefit and that the drugmaker had not performed necessary trials.<\/p>\n
Such a post from the FDA\u2019s top drugmaker turned heads. Aurinia claims its share price fell 20 percent in a matter of hours, dropping $350 million in market value.<\/p>\n
\u201cEmbarrassing\u201d<\/p>\n
Aurinia pushed back in the lawsuit, saying that the drug had undergone a full FDA approval process\u2014not an abbreviated one\u2014and been assessed based on a validated surrogate endpoint that is known to predict clinical outcomes. Further, the drug has been approved for use in 36 other countries in addition to the US.<\/p>\n
On Sunday, Tidmarsh offered his resignation, but on Monday, pharmaceutical industry publication Endpoints News reported<\/a> that Tidmarsh had notified FDA staff that he planned to fight the investigation and was reconsidering his decision to resign.<\/p>\n If the allegations in Aurinia\u2019s lawsuit are true, Tidmarsh\u2019s behavior would be egregious for a federal regulator. But already, the claims and other scandals have outsiders concerned that the high-stakes \u201csoap opera\u201d is destroying the agency\u2019s credibility, as Stat reported Tuesday<\/a>.<\/p>\n \u201cWe are witnessing nothing less than a clown show at FDA right now,\u201d one venture capital investor told the outlet. \u201cFor the sake of patients, we need a stable and consistent FDA!\u201d<\/p>\n \u201cWhat\u2019s happening at the top of the FDA is embarrassing,\u201d a portfolio manager at a large biotech fund added. \u201cHow am I supposed to convince people, other investors, that this sector is doing important work when the leaders of the FDA are acting this way?\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"In September, Tidmarsh went after Tang\u2019s Aurinia and its drug voclosporin that treats lupus nephritis, a disease in…\n","protected":false},"author":2,"featured_media":89560,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":{"0":"post-115894","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-il","10":"tag-israel","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/115894","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=115894"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/115894\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/89560"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=115894"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=115894"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=115894"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}