{"id":5911,"date":"2015-03-25T17:31:00","date_gmt":"2015-03-25T17:31:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/scary-pharmadrug-ads-in-medical-journals\/"},"modified":"2019-02-21T01:15:58","modified_gmt":"2019-02-21T01:15:58","slug":"scary-pharmadrug-ads-in-medical-journals","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/scary-pharmadrug-ads-in-medical-journals\/","title":{"rendered":"Scary Pharma\/Drug Ads in Medical Journals"},"content":{"rendered":"

Drug print ads aimed at patients are usually upbeat showing the benefits of the pill. Print ads intended for physicians on the other hand are often dark and downright scary. I came across this medical journal print ad about “poorly controlled LDL-C” yesterday:<\/p>\n\n\n\n\n
<\/a><\/td>\n<\/tr>\n
Click on image for an enlarged view<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

What’s up with this?<\/p>\n

<\/a>Obviously, this male caucasian businessman is going to get splattered all over what appears to be Wall Street by that scary LDL-C particle zooming straight for him. Look out dude! Too late. Splat!<\/p>\n

This ad does not mention a drug name because Sanofi\/Regeneron do not yet have marketing approval for PraluentTM (alirocumab), which is an investigational monoclonal antibody targeting “PCSK9 (proprotein convertase subtilisin\/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia.” But it was just announced that the FDA has accepted Praluent for priority review (see press release<\/a>). The ad is just the opening salvo for marketing this drug, which may be on the market as early as this summer.<\/p>\n

BTW, the press release cited above DOES mention the drug trade name and the indication, but does not include any important safety information (ISI) that otherwise would be required by the FDA. Interesting.<\/p>\n

UPDATE (26-MAR-2015): Regarding ISI in press releases, I received this comment via email from an anonymous “Regulatory Affairs Sheldon Leonard”:<\/p>\n

\nI\u2019m taking the liberty of responding privately via email to offer my opinion as to why Sanofi\u2019s press release didn\u2019t include the fair balance bells & whistles. [Disclosure: I don\u2019t work for them, and I\u2019m not a lawyer!]<\/p>\n

There are two main reasons: first, the company hasn\u2019t developed a F\/B paragraph (or as we sometimes call it in industry, the \u201cISI\u201d or important safety information) since the BLA was just filed and the label isn\u2019t finalized. They\u2019ll go through that exercise as they\u2019re closer to approval, and in any case will nail down the ISI upon approval. Don\u2019t be surprised to see some flavor of it in future press releases. But not to appease the FDA.<\/p>\n

Which brings me to the second (and probably more important) reason why the ISI isn\u2019t in the press release: it\u2019s directed at investors. Ostensibly the PR isn\u2019t intended to be promotional (or in this case, pre-promotional). Companies will say their communications to investors are monitored by the SEC, thus it\u2019s outside of FDA\u2019s jurisdiction.<\/p>\n

\u2018course, that hasn\u2019t stopped Tom Abrams from sending enforcement letters to companies over press releases when his group at FDA feels they\u2019ve crossed a line. (Check out this 2002 letter to Burzynki Research Institute<\/a>; this 1997 letter to Wyeth-Ayerst<\/a>; and this 1998 letter to Celgene<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

Drug print ads aimed at patients are usually upbeat showing the benefits of the pill. Print ads intended for physicians on the other hand are often dark and downright scary. I came across this medical journal print ad about “poorly controlled LDL-C” yesterday: Click on image for an enlarged view What’s up with this? Obviously, […]<\/p>\n","protected":false},"author":2,"featured_media":11831,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[409],"topic":[],"acf":[],"yoast_head":"\nScary Pharma\/Drug Ads in Medical Journals - 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\/blog\/scary-pharmadrug-ads-in-medical-journals\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Scary Pharma\/Drug Ads in Medical Journals - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Drug print ads aimed at patients are usually upbeat showing the benefits of the pill. 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