MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'ddmac'. Sat, 03 Sep 2011 02:52:13 +0100 http://www.medworm.com/index.php?rid=4715131&cid=t_165916_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F04%2F15%2Fupcoming-event-fda-basics-webinar-by-the-center-for-drug-research-and-evaluation-on-the-bad-ads-program-april-28-2011-at-12-noon-et%2F Did you know that healthcare providers can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading ads? As part of FDA Basics, FDA is hosting a webinar where you can learn more. Catherine Gray, Pharm.D., in the Division of Drug Marketing, Advertising, and Communication (DDMAC) in FDA’s Center for Drug Research and Evaluation will present an overview of the FDA’s “Bad Ad” program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency. The free 30 minute webinar will be held Thursday, April 28 at 12 noon ET. There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FD... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4715131 Fri, 15 Apr 2011 12:58:12 +0100 4715131 http://www.medworm.com/index.php?rid=4249237&cid=t_165916_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F12%2Fpharmaguy-alerts-fda-about-badad.html I just received an email message from the FDA thanking me for calling their attention to a "technical glitch" in the auto-response to submissions to its "BadAd" program (see email message reproduced below; click on it for an enlarged view).It's gratifying to know that I have been of service to my country. I wonder, however, why this "glitch" wasn't noticed until now. The BadAd program was launched by the FDA in May 2010 (see press release). It's impossible to know how many people/HCPs like me submitted a report about a potential violation in drug promotion by sending an email to badad@fda.gov or calling 877-RX-DDMAC. "While we cannot provide status updates on ongoing investigations to persons outside the Agency," says the FDA, "health care providers can subscribe to our e-mail updates to r... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4249237 Fri, 10 Dec 2010 20:16:00 +0100 4249237 http://www.medworm.com/index.php?rid=3827348&cid=t_165916_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPJSB-Co_w5E%2F Here is an interesting dichotomy: At the same time that AstraZeneca is forking out tens of millions of dollars to settle thousands of product-liability lawsuits claiming the risks of its Seroquel antipsychotic were not properly disclosed (see this), the drugmaker is tagged by the FDA for distributing promotional material that, among other things, fails to mention the risk that promped the lawsuits - a link to diabetes. A July 29 letter sent by the Division of Drug Marketing and Advertising Communications notes that the efficacy of Seroquel XR was overstated and risk info was omitted in so-called leave-behind sheets. For instance, various studies were cited, but overstated remission rates, the FDA scolded. “These claims misleadingly suggest that patients will achieve ‘remission... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827348 Thu, 05 Aug 2010 12:19:23 +0100 3827348 http://www.medworm.com/index.php?rid=3772465&cid=t_165916_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKsN_qae6b4M%2F The general idea behind a patient brochure is to sell a drug, but the FDA, as you know, also wants a drugmaker to include comprehensive, easy-to-find, readable info about safety and effectiveness, too. So omitting or minmizing such things should be avoided. And drugmakers ought to know, but sometimes - you can confess - a company may forget, or maybe push things a little too far. That’s what Jazz Pharmaceuticals did with a brochure that was submitted to the agency for its Luvox CR pill used to treat social anxiety disorder and obsessive-compulsive disorder. The agency staff took a close look and, lo and behold, the drugmaker received a warning letter that reads like a grade-school primer for pharma marketers who need lessons on how to include the correct info. The bottom-line - impor... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772465 Tue, 20 Jul 2010 16:57:11 +0100 3772465 http://www.medworm.com/index.php?rid=3556373&cid=t_165916_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhMiG48LwPMA%2F Yesterday, the FDA launched what it calls a new educational outreach effort to encourage doctors and other healthcare providers to report misleading prescription drug promotion and provide them with an easy way to report this activity to the agency’s DDMAC, the Division of Drug Marketing, Advertising, and Communications, which issues warning letters for violations. The hope for the BadAd program is that drugmakers will toe the line and curtail promotional efforts that go too far. We spoke with Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, about the program… Pharmalot: Do you think the program is warranted? Friede: From the FDA’s prepecrtive, we are see an ongoing and even increasing amount of correspondence from DDMAC,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3556373 Wed, 12 May 2010 13:17:06 +0100 3556373 http://www.medworm.com/index.php?rid=3556378&cid=t_165916_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfAGgDJ3OVfM%2F If you’re a doctor, the FDA wants your help in identifying ‘bad’ advertisements for prescription drugs. Seriously. The agency is calling it’s new ‘Bad Ad’ program an educational outreach effort and, not surprisingly, it’s being run by DDMAC, the agency’s Division of Drug Marketing, Advertising, and Communications, which issues all those warning letters and violations. The goal of the program is to “help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” DDMAC director Tom Abrams says in a statement. Usually, the FDA finds ‘bad ads’ by reviewing promotional materials submitted for agency review, fielding complaints (often one company s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3556378 Tue, 11 May 2010 17:26:52 +0100 3556378 http://www.medworm.com/index.php?rid=3534105&cid=t_165916_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLwhnA_uUGwM%2F Reading the April 21 warning letter from the FDA to Novartis is a bit like reading a primer on how not to promote one’s drug on the Internet. Where to begin? Well, Novartis was tagged by the FDA after its DDMAC division reviewed two web sites - gistalliance.com and cmlalliance.com - which were sponsored by the drugmaker, but are now out of commission. The problem? The web sites don’t mention the Gleevec cancer drug by name, but come close enough to ruffle the FDA. In effect, these disease awareness sites came off as so-called product branded sites. And so the agency writes these were “false and misleading because they promote the drug for an unapproved use, fail to disclose the risks associated with the use of Gleevec and make unsubstantiated dosing claims, (which) can pu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3534105 Tue, 04 May 2010 20:05:08 +0100 3534105 http://www.medworm.com/index.php?rid=3449138&cid=t_165916_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fanalysis-of-ddmac-warning-letters.html The FDA Amendments Act (FDAAA), which was signed into law in 2007, requires that the FDA issue new regulations regarding the presentation of risk information in broadcast (TV and radio) drug ads directed to consumers (DTC ads). On March 29, 2010, the FDA published the proposed regulations in the Federal Register (see here). FDA had issued guidance relating to presentation of risk information previously and most experts agree that the proposed regulations pretty closely resemble that guidance (see "Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion"; pdf file).Specifically, the regulations focus on determining whether a drug ad's "major statement" (ie, disclosure of the major side effects and contraindications of the drug) is presented in a "clea... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3449138 Thu, 08 Apr 2010 15:02:00 +0100 3449138 http://www.medworm.com/index.php?rid=3231803&cid=t_165916_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fd2ufebUMIJs%2F The number of FDA warnings issued for questionable promotions has nearly doubled since President Obama took office. The agency sent 41 enforcement letters in 2009, up from 21 in 2008, according to Tom Abrams, who heads the agency’s Division of Drug Marketing, Advertising and Communications. Meanwhile, nine letters were sent just last month (see here). “We’re trying to get the point across to industry that we want them to comply with the law because it affects public health. If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or healthcare professionals misled,” Abrams told Reuters, citing an edict from FDA commish Margaret Hamburg. “We are inspired by Dr. Hamburg’s enforcement initiative and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3231803 Tue, 02 Feb 2010 13:34:23 +0100 3231803 http://www.medworm.com/index.php?rid=1634898&cid=t_165916_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F07%2Fcan-moratorium-delayed-dtc-ad-refer-to.html Last month, WSJ Health Blog reported that "Drugmakers [Merck, Pfzier, J&J, to name a few] called before Congress to explain their direct-to-consumer [DTC] ads have agreed to wait six months before advertising newly approved drugs to the general public."But I wonder if marketers in these companies have has asked themselves this question:Given DDMAC’s policy that a new drug can only be new for six months after marketing launch, does that mean that brands who observe a 6-month or longer DTCA moratorium cannot claim "new" in their consumer ads?That was a question recently posed by a client to my long-time colleague and Pharma Marketing Roundtable member, Mario Cavallini, Manager of Competitive Intelligence at Rosetta Marketing, who answered:Interesting question; I don’t know whether an... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1634898 Thu, 17 Jul 2008 14:22:00 +0100 1634898 http://www.medworm.com/index.php?rid=1391037&cid=t_165916_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F04%2Fviolative-viva-viagra-video-still-there.html On April 16, 2008, the FDA's DDMAC asked Pfizer to "immediately cease dissemination of violative promotional materials for Viagra" -- namely a video on the Viagra Web site that shows a group of men in a Nashville studio playing instruments and singing the following song:"Hey fellas, check this out... First time I saw her, she set my world.. .y'know she set my world to reeling and as the years go by, for this country guy... well, we never lost the feelin'. Well, this bily goat, I played my last note...can't wait...I can't wait to get home. ..Viva Viagra!""The video," says DDMAC in its letter to Pfizer CEO Jeff Kindler, "then ends with an audio voice over that states 'Talk to your doctor about Viagra, America's most prescribed treatment for erectile dysfunction.' This video is misleading bec... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1391037 Tue, 22 Apr 2008 17:55:00 +0100 1391037 http://www.medworm.com/index.php?rid=1170418&cid=t_165916_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F221250644%2F Congress is pressing Merck and Schering-Plough for information on the timing of executive stock sales in the wake of the delayed release of results from the Enhance trial — a long-awaited study whose results became public last week. The findings suggest the cholesterol drug Vytorin doesn’t slow heart disease any better than a generic statin alone. Schering-Plough’s stock has taken a beating since then (see 10-day chart). “We have … discovered that a Schering-Plough officer, Carrie Smith Cox, sold significant numbers of shares of Schering-Plough in the time between the end of the ENHANCE study and the release of the results on January 14, 2008,” Congressmen Bart Stupak and John Dingell wrote in their latest letter to the companies today. But Schering-Pl... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=1170418 Wed, 23 Jan 2008 12:17:47 +0100 1170418