{"id":13011,"date":"2011-11-03T18:48:05","date_gmt":"2011-11-03T22:48:05","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&p=13011"},"modified":"2011-11-03T18:48:05","modified_gmt":"2011-11-03T22:48:05","slug":"fda-approves-tavr-but-remains-in-the-crosshairs","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/11\/03\/fda-approves-tavr-but-remains-in-the-crosshairs\/","title":{"rendered":"FDA Approves TAVR But Remains in the Crosshairs"},"content":{"rendered":"

I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV<\/em><\/strong>) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR).<\/p>\n

The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER <\/a>study; (b) collaboration and support of the Society of Thoracic Surgeons and the American College of Cardiology; and (c) a commitment to create a national registry for post-marketing studies.<\/p>\n

I was surprised\u00a0\u2014 perhaps naively\u00a0\u2014 by the wide range of opinions regarding the FDA process.<\/em><\/strong><\/p>\n

In the past several weeks, the FDA was blasted by a former Food and Drug Administration deputy commissioner for taking too long to approve the THV<\/a>, and a group of senators introduced the Medical Device Regulatory Improvement Act<\/a>, seeking to streamline FDA\u2019s pre-market device oversight by directing the agency not to ask companies for more data than it needs.<\/p>\n

Simultaneously, in a JAMA piece<\/a>, Harlan Krumholz recommended a new industry model that encourages more \u2014 not less \u2014 scrutiny of study results.\u00a0 Specifically, Harlan called for:<\/p>\n

    \n
  1. An external coordinating organization<\/em><\/strong> (an academic center) to contract with the medical device manufacturer, which agrees\u00a0to provide access to all of its source material (i.e., patient-level clinical research data), post-marketing studies, and safety programs<\/li>\n
  2. The\u00a0coordinating organization to\u00a0contract with\u00a0two<\/em> qualified groups<\/em><\/strong> to conduct independent reviews of the data<\/li>\n
  3. A steering committee,<\/em><\/strong> consisting of subject-matter experts as well as patients, investigators, and policy makers, that is selected by the coordinating organization to provide oversight and guidance.<\/li>\n
  4. All data to be made available\u00a0by the coordinating organization to other investigators<\/li>\n<\/ol>\n

    A\u00a0recent NEJM opinion piece <\/a>acknowledges that the FDA has been \u201csimultaneously faulted for inadequate assurance of safety and efficacy and for suppressing innovation.\u201d<\/p>\n

    You can\u2019t have it both ways.\u00a0 So which is it?<\/em><\/strong><\/p>\n

    Does the FDA need fewer rules and a more streamlined process, or does it need additional oversight?\u00a0 Which best serves our patients? <\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

    I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR). The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER study; (b) collaboration and support of the Society of Thoracic Surgeons […]<\/p>\n","protected":false},"author":214,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,9],"tags":[222,396,423],"class_list":["post-13011","post","type-post","status-publish","format-standard","hentry","category-general","category-interventional-cardiology","tag-fda-approvals","tag-partner","tag-tavi"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13011","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/214"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=13011"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13011\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=13011"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=13011"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=13011"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}