{"id":6815,"date":"2010-06-17T18:07:00","date_gmt":"2010-06-17T18:07:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/fda-sucker-punches-sepracor-wi\/"},"modified":"2019-02-21T01:21:46","modified_gmt":"2019-02-21T01:21:46","slug":"fda-sucker-punches-sepracor-wi","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-sucker-punches-sepracor-wi\/","title":{"rendered":"FDA Sucker Punches Sepracor with Warning Letter After the Match Is Over!"},"content":{"rendered":"

On June 9, 2010, Carrie Newcomer, Regulatory Review Officer in FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC), sent a “warning” letter<\/a> to Kathleen Grim, Executive Director, Regulatory Compliance at Sepracor Inc., about a Lunesta TV ad that Newcomer said “presents unsubstantiated claims, including unsubstantiated superiority claims.”<\/p>\n

The ad in question is the so-called “Boxing Bed” ad, which shows a sleepless woman tossing and turning in a bed that is also a boxing ring. Here’s a panel from the storyboard<\/a> that was submitted to the FDA on November 19, 2009, about the time the ad first ran on TV:<\/p>\n

<\/a><\/div>\n

This ad was voted one of “The 10 Worst TV Ads of 2009” (see here<\/a>).<\/p>\n

In other words, the ad appeared way back in 2009 and the FDA is just now sending Sepracor a warning letter after having the storyboard in its possession for 7 months! Of course, the ad has run its course and Sepracor and Lunesta have long left the ring. But the FDA still went after them with this sucker punch.<\/p>\n

What is FDA demanding? “DDMAC requests that Sepracor immediately cease the dissemination of violative promotional materials for Lunesta such as those described above. Please submit a written response to this letter on or before June 23, 2010, stating whether you intend to comply with this request…”<\/p>\n

I imagine a grin on Ms. Grim’s face as she sits in her office somewhere in Malborough, MA reading Newcomer’s letter. “Yes,” says Grim, “we’ll cease airing that commercial three months ago and I will write this ‘newcomer’ a response as soon as I return from my vacation on the Cape. Meanwhile, I’ll have my staff frame this letter to add to the collection hanging behind my desk.”<\/p>\n

BTW, while searching Google for this ad, I found an interesting Lunesta paid search ad as seen here:<\/p>\n

<\/a><\/div>\n

This is the first time I have ever seen a drug ad that talks ONLY about side effects! I assure you that the ad linked to the official Lunesta Web site and NOT a lawyer’s class action Web site. Perhaps Sepracor is trying to atone for running those infamous “badWords,” which violated FDA regulations (see Lunesta, Google, and “bAdWords”<\/a>).<\/p>\n","protected":false},"excerpt":{"rendered":"

On June 9, 2010, Carrie Newcomer, Regulatory Review Officer in FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC), sent a “warning” letter to Kathleen Grim, Executive Director, Regulatory Compliance at Sepracor Inc., about a Lunesta TV ad that Newcomer said “presents unsubstantiated claims, including unsubstantiated superiority claims.” The ad in question is the so-called […]<\/p>\n","protected":false},"author":2,"featured_media":9943,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[712,713,70],"topic":[],"acf":[],"yoast_head":"\nFDA Sucker Punches Sepracor with Warning Letter After the Match Is Over! - 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=\"https:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-sucker-punches-sepracor-wi\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Sucker Punches Sepracor with Warning Letter After the Match Is Over! 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