{"id":2262,"date":"2017-04-07T00:00:00","date_gmt":"2017-04-07T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.comindex.php\/2017\/04\/07\/pinup040717\/"},"modified":"2019-02-06T02:14:39","modified_gmt":"2019-02-06T02:14:39","slug":"pinup040717","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/news\/pinup040717\/","title":{"rendered":"PinUp: Dr. Scott Gottlieb Answers Questions About Drug Safety, Speeding FDA&#8217;s Drug Approval Process, and the Opioid Epidemic at His Senate Conformation Hearing, more&#8230;"},"content":{"rendered":"<p><b>Pharma Industry News Update<\/b>: 7 April 2017<\/p>\n<hr\/>\n<p>Gottlieb&#8217;s Views on Drug Safety Versus Speed to Market    In this 3.5-minute audio snippet, Pharmaguy summarizes the testimony of Dr. Scott Gottlieb, president Trump&#8217;s nominee to head the FDA, before the U.S. Senate Committee on Health, Education, Labor and Pensions. In particular, where&#8217;s the balance between drug safety and speeding up clinical trials to bring drugs to market faster?<\/p>\n<p>              <img loading=\"lazy\" decoding=\"async\" height=\"1\" vspace=\"0\" border=\"0\" hspace=\"0\" width=\"5\" class=\"SpacerImage\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/S.gif\"\/>                              <img decoding=\"async\" vspace=\"0\" border=\"0\" hspace=\"0\" style=\"display: block; height: auto !important;\" width=\"250\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2017\/04\/Warren-v-Gottlieb-about-Safety.jpg\"\/>                          Senator Warren Goes After Gottlieb Regarding Drug Safety<\/p>\n<p>From www.pharma-mkting.com<\/p>\n<p>        At his April 5, 2017, Senate confirmation hearing, Dr. Scott Gottlieb, President Trump&#8217;s nominee for FDA Commissioner, responded to Massachusetts Senator Elizabeth Warren&#8217;s concern about his commitment to FDA&#8217;s basic safety mission.<\/p>\n<p>Senator Warren cited Gottlieb&#8217;s comments about how the thalidomide episode had a lasting effect on the FDA&#8217;s work. The comments appeared in a 2012 article titled &#8220;Changing the FDA&#8217;s Culture.&#8221;<\/p>\n<p>In that article, Gottlieb said &#8220;In so heavily prioritizing one of its obligations &#8211; the protection of consumers &#8211; the FDA has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market.&#8221;<\/p>\n<p><a href=\"http:\/\/sco.lt\/6cwNvN\">More here&#8230;<\/a><\/p>\n<p><b>Further Reading &amp; Listening:<\/b><\/p>\n<ul>\n<li><a href=\"http:\/\/bit.ly\/warren-v-gott-snippet\">Listen to the exchange between Warren &amp; Gottlieb here<\/a>.<\/li>\n<li><a href=\"http:\/\/sco.lt\/6kfno9\">Frances Kelsey Was No Hero, Says @DrBobGoldberg, the Donald Trump of #Pharma Bloggers<\/a><\/li>\n<li><a href=\"http:\/\/sco.lt\/7u2s1R\">What Thalidomide Teaches Us About Off-Label Drug Promotion<\/a><\/li>\n<\/ul>\n<hr\/>\n<p>        <img loading=\"lazy\" decoding=\"async\" height=\"1\" vspace=\"0\" border=\"0\" hspace=\"0\" width=\"5\" class=\"SpacerImage\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/S.gif\"\/>                              <img decoding=\"async\" vspace=\"0\" border=\"0\" hspace=\"0\" style=\"display: block; height: auto !important;\" width=\"250\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2017\/04\/gold-standard.png\"\/>                          Gottlieb Redefines What is Meant by &#8220;Gold Standard&#8221; at His Senate Hearing<\/p>\n<p>From www.statnews.com<\/p>\n<p>        When Dr. Scott Gottlieb pledged at his confirmation hearing to uphold a &#8220;gold standard of safety and efficacy&#8221; at the Food and Drug Administration, he raised an important question: <\/p>\n<p>What exactly does he mean by that?  <\/p>\n<p>Traditionally, &#8220;gold standard&#8221; refers to robust, randomized controlled clinical trials. But there&#8217;s enormous pressure on the FDA from pharma companies and Congress to accept other kinds of evidence, perhaps even patient anecdotes, to determine whether experimental drugs work. And President Trump is promising to speed drug approvals.  <\/p>\n<p>So when Gottlieb said: &#8220;I think there are ways to modernize clinical studies without sacrificing the gold standard,&#8221; he raised red flags.<\/p>\n<p><a href=\"http:\/\/sco.lt\/5Ahru5\">More here&#8230;<\/a><\/p>\n<p><b>Further Reading:<\/b><\/p>\n<ul>\n<li><a href=\"http:\/\/sco.lt\/5lvD1N\">Former FDA Commish Califf Debunks Faster Drug Approvals<\/a><\/li>\n<li><a href=\"http:\/\/sco.lt\/6moIwD\">We Want the &#8220;Gold Standard&#8221; of FDA Approval, Says PhRMA CEO Ubl<\/a><\/li>\n<\/ul>\n<hr\/>\n<p>        Dr. Gottlieb&#8217;s Comments on Opioid Epidemic                        <img decoding=\"async\" vspace=\"0\" border=\"0\" hspace=\"0\" style=\"display: block; height: auto !important;\" width=\"450\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2017\/04\/Opioid_epidemic_word_cloud.jpg\"\/>             From soundcloud.com\/john-pharmaguy-mack<\/p>\n<p>        At his April 5, 2017, Senate confirmation hearing, Dr. Scott Gottlieb, President Trump&#8217;s nominee for FDA Commissioner, answered questions about the opioid epidemic thrown at him by Senators Tim Kaine, Michael Bennet, and Al Franken.<\/p>\n<p><a href=\"http:\/\/bit.ly\/GottvOpioid\">Listen to Gottlieb&#8217;s comments here<\/a>.<\/p>\n<p><b>Further Reading:<\/b><\/p>\n<ul>\n<li><a href=\"http:\/\/sco.lt\/5mYWrx\">How a One Paragraph Letter to the Editor Launched the Opioid Epidemic<\/a><\/li>\n<li><a href=\"http:\/\/sco.lt\/5Ud2rh\">John Oliver Shreds Pharmaceutical Industry Over Massive Opioid Crisis<\/a><\/li>\n<li><a href=\"http:\/\/sco.lt\/9Mufmj\">Opioid Epidemic Getting Worse Due to FDA, Which Now Says It Will Change Its Ways<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Welcome to the April 7, 2017, issue of Pharma Industry News Update (aka PinUp). Where&#8217;s the balance between drug safety and speeding up clinical trials to bring drugs to market faster? That was a major issue underscoring the testimony of Dr. Scott Gottlieb, president Trump&#8217;s nominee to head the FDA, before the U.S. Senate Committee on Health, Education, Labor and Pensions.<\/p>\n","protected":false},"author":2,"featured_media":2756,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[15],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PinUp: Dr. Scott Gottlieb Answers Questions About Drug Safety, Speeding FDA&#039;s Drug Approval Process, and the Opioid Epidemic at His Senate Conformation Hearing, more... - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/news\/pinup040717\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PinUp: Dr. Scott Gottlieb Answers Questions About Drug Safety, Speeding FDA&#039;s Drug Approval Process, and the Opioid Epidemic at His Senate Conformation Hearing, more... - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Welcome to the April 7, 2017, issue of Pharma Industry News Update (aka PinUp). Where&#039;s the balance between drug safety and speeding up clinical trials to bring drugs to market faster? 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