{"id":3333,"date":"2003-11-01T00:00:00","date_gmt":"2003-11-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2003\/11\/01\/pmn211-oped\/"},"modified":"2019-02-18T17:51:30","modified_gmt":"2019-02-18T17:51:30","slug":"pmn211-oped","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn211-oped\/","title":{"rendered":"OpEd: Risky Business"},"content":{"rendered":"

Risky Business<\/b>
Vol. 2, No.11: December 2003 <\/p>\n

OpEd by John Mack <\/p>\n

Paraphrasing a comment I heard at a recent industry conference, “a product manager with an FDA warning letter framed and hanging on the office wall has bragging rights.” <\/p>\n

Perhaps this allegory of bravado is just a PM “urban legend.” Nevertheless, designing and implementing pharmaceutical marketing campaigns is a risky business these days, as pharma companies contend with intense public scrutiny. <\/p>\n

Product managers may take more risks than necessary and there may be few regulations that define a bright line between allowed and not allowed activities. <\/p>\n

Off-label communications is a case in point. There are no regulations or firm guidance from the FDA on dissemination of off-label information. Often, the limits are being set by court decisions resolving federal false claims cases. Clearly, this is not where pharmaceutical companies want to be. <\/p>\n

All the public scrutiny has led to new guidance from the OIG, self-regulatory guidelines from the pharmaceutical industry itself, and pressure from non-governmental organizations like the ACCME. The result is more work for pharmaceutical compliance officers who are playing a larger role in pharmaceutical marketing. <\/p>\n

Marketers need to understand the rules, but also work more closely with compliance officials – suggestions for how to do this can be found in this month’s article “Integrating Compliance into Commercial Practices<\/a>.” <\/p>\n

Experts warn regulators are putting off-label promotion at the top of their “most-wanted lists.” So, before you begin an off-label information dissemination program, be sure to read the “Seven Steps to Safety” outlined in the article “Guidelines for Off-label Communication<\/a>.” <\/p><\/p>\n","protected":false},"excerpt":{"rendered":"

Product managers may take more risks than necessary and there may be few regulations that define a bright line between allowed and not allowed activities.<\/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":[52,6],"tags":[],"topic":[],"acf":[],"yoast_head":"\nOpEd: Risky Business - 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\/pmn211-oped\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OpEd: Risky Business - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Product managers may take more risks than necessary and there may be few regulations that define a bright line between allowed and not allowed activities.\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn211-oped\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2003-11-01T00:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-18T17:51:30+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"744\" \/>\n\t<meta property=\"og:image:height\" content=\"419\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Pharma Guy\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Pharma Guy\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn211-oped\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn211-oped\/\",\"name\":\"OpEd: Risky Business - 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