{"id":1869,"date":"2013-03-29T05:56:00","date_gmt":"2013-03-29T00:56:00","guid":{"rendered":"http:\/\/www.policymed.com\/fda-reorganizing-office-of-prescription-drug-promotion\/"},"modified":"2018-05-06T14:37:20","modified_gmt":"2018-05-06T09:37:20","slug":"fda-reorganizing-office-of-prescription-drug-promotion","status":"publish","type":"post","link":"https:\/\/www.policymed.com\/2013\/03\/fda-reorganizing-office-of-prescription-drug-promotion.html","title":{"rendered":"FDA Reorganizing Office of Prescription Drug Promotion"},"content":{"rendered":"<p><span style=\"font-family: arial,helvetica,sans-serif;\">Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) announced a new restructuring of FDA\u2019s Office of Prescription Drug Promotion (OPDP).\u00a0 As we noted back in the fall of 2011, FDA reorganized its previous office\u2014the Division of Drug Marketing, Advertising, and Communications (DDMAC) into OPDP.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">OPDP works to protect the public health by ensuring that all prescription drug promotional labeling and advertising directed to health care professionals and consumers is truthful, balanced, and not misleading.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Shortly after launching OPDP, the office created a new \u201c<a href=\"http:\/\/www.policymed.com\/2010\/05\/fda-bad-ad-program-how-to-train-your-sales-rep.html\">Bad Ad Program<\/a>,\u201d which subsequently issued a <a href=\"http:\/\/www.policymed.com\/2011\/06\/fda-first-year-report-on-bad-ad-program.html\">few yearly reports<\/a> about its progress in educating physicians and \u201cdeputizing\u201d them to report fraudulent or questionable detailing or advertising.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Recently, OPDP reviewed and analyzed the workload and review processes in its two divisions, the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion, in an effort to improve upon their overall impact and effectiveness. \u00a0The goal of this analysis was to increase efficiency, improve work distribution, and eliminate redundancy.\u00a0\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Through the analysis, OPDP concluded that a structure that integrates the review of health care professional-directed and consumer-directed promotion across the two divisions would meet this goal.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Toward this goal, OPDP will be restructuring its divisions and, pending final approval, will rename them the <a href=\"http:\/\/www.fda.gov\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDER\/ucm154886.htm?source=govdelivery\">Division of Advertising and Promotion Review<\/a> I and the Division of Advertising and Promotion Review II. \u00a0Both divisions will handle health care and consumer promotion. \u00a0As a way to distribute the work evenly, each division will oversee different therapeutic classes of drugs. \u00a0These changes will allow OPDP to review direct-to-consumer (DTC) and health professional advertising more effectively.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Woodcock acknowledged the importance of DTC ads, and noted that it is \u201coften the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions.\u201d \u00a0Woodcock noted that the \u201cdecision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising. The new structure will improve efficiency in our program area and our ability to meet the health needs of the American public.\u201d\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Finally, she noted that \u201cODPD reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers.\u201d\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Whether this new restructuring will help in speeding up the issuance of the long-awaited Social Media guidance is yet to be seen.\u00a0\u00a0\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) announced a new restructuring of FDA\u2019s Office of Prescription Drug Promotion (OPDP).\u00a0 As we noted back in the fall of 2011, FDA reorganized its previous office\u2014the Division of Drug Marketing, Advertising, and Communications (DDMAC) into OPDP.\u00a0 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8595,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[1101],"class_list":["post-1869","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda","tag-new"],"_links":{"self":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1869","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/comments?post=1869"}],"version-history":[{"count":2,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1869\/revisions"}],"predecessor-version":[{"id":8597,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1869\/revisions\/8597"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media\/8595"}],"wp:attachment":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media?parent=1869"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/categories?post=1869"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/tags?post=1869"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}