{"id":5621,"date":"2015-01-01T00:00:00","date_gmt":"2015-01-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2015\/01\/01\/pmn1401-article03\/"},"modified":"2019-02-18T20:38:45","modified_gmt":"2019-02-18T20:38:45","slug":"pmn1401-article03","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1401-article03\/","title":{"rendered":"2014 Was a Good Year for FDA &amp; Pharma: Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions"},"content":{"rendered":"<p>2014 Was a Good Year for FDA &amp; Pharma        Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions<br \/><img loading=\"lazy\" decoding=\"async\" alt=\"Bang and Whimper\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/FDA-Approvals-v-Enforcemnet-400x339.png\" width=\"400\" height=\"339\" align=\"right\" hspace=\"7\" vspace=\"5\"\/>The U.S. Food and Drug Administration (FDA) ended 2014 with a bang <i>and<\/i> a whimper. <\/p>\n<p>The Agency approved a total of 41 new molecular entities (NMEs) and biologics (BLAs) in 2014, the greatest number since 1996. That was the bang. FDA, however, also ended the year with a whimper. The Agency sent out only a meager 10 advertising enforcement letters in 2014, the fewest ever. <\/p>\n<p>There may be a single explanation for both phenomena: the Prescription Drug User Fee Act  (PDUFA) payments to FDA from pharma. These payments now account for more than 65% of FDA&#8217;s budget for the approval and regulation of drugs.<\/p>\n<p><b>Topics (partial list)<\/b>:<\/p>\n<ul>\n<li>Orphan Drugs Are &#8220;Where the Money Is&#8221;<\/li>\n<li>Banging Drug Prices<\/li>\n<li>Wimpy Enforcement<\/li>\n<li>Busy, Busy FDA<\/li>\n<li>PDUFA Fees vs. Enforcement<\/li>\n<\/ul>\n<p>Download the full article (PDF file) here:<br \/><a style=\"color: #993300;\" track=\"on\" shape=\"rect\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmnews1401-article03.pdf\" linktype=\"link\">www.pharma-mkting.com\/news\/pmnews1401-article03.pdf<\/a>    <\/p>\n<p>PMN1401-03<br \/>Issue: Vol. 14, No. 2: January 2015<\/p>\n<p\/><b>Find other articles in related Topic Areas:<\/b> <\/p>\n<ul>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNphysMktingReprints.htm\">Physician Marketing &amp; Promotion<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNDTCReprints.htm\">Direct-to-Consumer (DTC) Advertising &amp; Marketing<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNRegComplianceReprints.htm\">Regulatory Compliance<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The FDA approved a total of 41 new molecular entities (NMEs) and biologics (BLAs) in 201 4but sent out only a meager 10 advertising enforcement letters in 2014, the fewest ever.<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[64,6],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>2014 Was a Good Year for FDA &amp; Pharma: Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions - 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\/pmn1401-article03\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2014 Was a Good Year for FDA &amp; 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