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 '#fdasm'. Wed, 21 Jul 2010 11:20:06 +0100 http://www.medworm.com/index.php?rid=3758112&cid=t_371715_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FBUyHB6__luE%2F10th-annual-epharma-summit-industry.html From: Kristin Paulick, IIRRe: 10th Annual ePharma SummitDeadline: Tuesday, July 27, 2010Event Dates: February 7-9, 2011Event Venue: The Sheraton Hotel & Towers, New York, New YorkSUBMIT YOUR PROPOSAL NOW!Production has begun for The 10th Annual ePharma Summit. The event will be February 7-9, 2011 in New York, NY at The Sheraton Hotel and Towers and will include 3 days of networking, interactive presentations, workshops, panels, and collaborative activities.We are actively recruiting corporate practitioners who can share e-marketing (consumer or HCP-focused) case studies. We invite you to submit a speaking proposal directly to Kristin Paulick, Program Director, on or before Tuesday, July 27, 2010. Send to kpaulick@iirusa.com or call 646-895-7331.Please note: abstracts are revi... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3758112 Thu, 15 Jul 2010 13:00:00 +0100 3758112 http://www.medworm.com/index.php?rid=3737290&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F07%2Fif-social-media-were-quicksand-youll.html My Twitter pal @PhilBaumann made a comparison between social media and quicksand in his blog. "What I’m saying is this," said Phil, "you can learn to swim in quick sand. But you’ll drown if you think you’re walking on solid ground. Sometimes assuming the worst can help you understand and see what’s best." See "What If Social Media Was Called Quick Sand" to get the point Phil was trying to make, which is be aware of what's below the surface.Regardless of the point that Phil was trying to make, his statement immediately conjured up an image in my mind, which having nothing better to do, I created in Photoshop and posted here on the left.In reply to Phil's comment, I tweeted  "You can't swim in quicksand, but you CAN dip your toe in. Exactly what pharma is doing in SM now."What's... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3737290 Thu, 08 Jul 2010 15:01:00 +0100 3737290 http://www.medworm.com/index.php?rid=3676891&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F06%2Fi-predicted-it-social-media-guidance.html "What had been envisioned as a massive, all-encompassing guidance on Internet promotion is being retooled as multiple guidances to address specific issues in the online realm," Tom Abrams, head of the Center for Drug Evaluation and Research's Division of Drug Marketing, Advertising and Communications (DDMAC) said during a panel discussion at the Drug Information Association's annual meeting in Washington, D.C., June 15. (Picked up from a "FDA Library Alert" email -- "DDMAC: Social Media Guidance Likely To Be Split Into Multiple Documents" -- I just received.)Either I can see into the future, or FDA reads my blog and takes my advice. In November, 2009, I said "If FDA decides to bite off more than it can chew, it will take a long time to issue any guidance and whatever it comes up with will ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3676891 Fri, 18 Jun 2010 19:35:00 +0100 3676891 http://www.medworm.com/index.php?rid=3570059&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F05%2Fgoogle-no-longer-allows-pharma.html Back in April 2009, I suggested that FDA might go after pharma marketers for using paid search redirects in Google Adwords (see "The Next FDA Concern May be the Use of 'Redirect' URLs"). Such ads use visible URLs such as "flaccidmember.com" but, when clicked, lead to viagra.com or cialis.com. Such an is considered to be "unbranded" and beyond FDA regulation. That is, it can say "Stay harder longer with this treatment for erectile dysfuntion" and lead directly to the branded website.The problem with that strategy is that Google's Adword policy forbids the use of redirect URLs -- for most advertisers. It appears that Google was making an exception for the pharmaceutical industry (see "Redirect URLs in Adwords: Who Knew What When?").Last week I thought Google may have rescinded this exception... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3570059 Thu, 13 May 2010 12:44:00 +0100 3570059 http://www.medworm.com/index.php?rid=3566807&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F05%2Fgoogle-no-longer-allows-pharma.html Back in April 2009, I suggested that FDA might go after pharma marketers for using paid search redirects in Google Adwords (see "The Next FDA Concern May be the Use of 'Redirect' URLs"). Such ads use visible URLs such as "flaccidmember.com" but, when clicked, lead to viagra.com or cialis.com. Such an is considered to be "unbranded" and beyond FDA regulation. That is, it can say "Stay harder longer with this treatment for erectile dysfuntion" and lead directly to the branded website.The problem with that strategy is that Google's Adword policy forbids the use of redirect URLs -- for most advertisers. It appears that Google was making an exception for the pharmaceutical industry (see "Redirect URLs in Adwords: Who Knew What When?").But Google may have rescinded this exception. Yesterday, Tyl... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3566807 Thu, 13 May 2010 12:44:00 +0100 3566807 http://www.medworm.com/index.php?rid=3560494&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F05%2Fgoogle-no-longer-allows-pharma.html Back in April 2009, I suggested that FDA might go after pharma marketers for using paid search redirects in Google Adwords (see "FDA Concern May be the Use of 'Redirect' URLs"). Such ads use visible URLs such as "flaccidmember.com" but, when clicked, lead to viagra.com or cialis.com. Such an is considered to be "unbranded" and beyond FDA regulation. That is, it can say "Stay harder longer with this treatment for erectile dysfuntion" and lead directly to the branded website.The problem with that strategy is that Google's Adword policy forbids the use of redirect URLs -- for most advertisers. It appears that Google was making an exception for the pharmaceutical industry (see "Redirect URLs in Adwords: Who Knew What When?").But Google may have rescinded this exception. Yesterday, Tyler Ransbu... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3560494 Thu, 13 May 2010 12:44:00 +0100 3560494 http://www.medworm.com/index.php?rid=3483116&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fvoltaren-adherence-email-gets-fda.html As of April 15, 2010, FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) sent out 5 "notice of violation" (aka "warning") letters to drug companies regarding various promotional pieces. One letter is of interest because it concerns a direct-to-consumer (DTC) adherence "wave 5 e-mail" ("Adherence Email") for Voltaren, an NSAID topical gel marketed by Novartis. This may be the FIRST FDA warning letter issued for an email promotion. But is it justified?Among other violations, the letter cites "minimization of risk information." The letter (find it here) states:"The Adherence Email prominently presents efficacy claims in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space. In contrast, the risk information is relegate... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3483116 Mon, 19 Apr 2010 12:59:00 +0100 3483116 http://www.medworm.com/index.php?rid=3468017&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fpre-screening-post-screening-or-no.html Discussions to 3rd Parties"). But I am on the fence regarding pre- vs. post-screening. A few organizations that submitted comments to the FDA in response to its questions about regulating pharma's use of social media addressed the issue of moderation (see, for example, "Accountability for Pharma Content on Social Media Sites"). LiveWorld, Inc. -- a social marketing agency with 20+ years creating, operating, and moderating online communities -- submitted the most detailed comments regarding moderation (find LiveWorld's comments here). In tomorrow's Pharma Marketing Talk LIVE podcast ("Online Community Management Moderation Best Practices & Other Tips for Pharma Social Media Managers"), I will be interviewing Jenna Woodul, who is the co-founder and Chief Community Officer of LiveWorld. J... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3468017 Wed, 14 Apr 2010 13:18:00 +0100 3468017 http://www.medworm.com/index.php?rid=3429446&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fwlf-pfizer-ask-court-to-block-fda.html Yesterday, in a move that is sure to delay if not completely halt FDA efforts to issue guidance on the regulation of drug promotion on the Internet and social media, the Washington Legal Foundation (WLF) and Pfizer filed a brief with U.S. District Court in Washington, DC.I was so pre-occupied getting the March 2010 issue of Pharma Marketing News out to my 7,300 subscribers that I completely missed this press release that came in my email inbox last night around 7 PM.The press release (find it here) states:COURT URGED TO ENJOIN FDA FROM BARRING SOCIAL MEDIA FREE SPEECH(Pfizer, Inc. v. United States, No. 10-223)"The Washington Legal Foundation (WLF) today urged the U.S. District Court for the District of Columbia to uphold First Amendment rights by limiting the authority of the Food and Drug... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3429446 Thu, 01 Apr 2010 08:40:00 +0100 3429446 http://www.medworm.com/index.php?rid=3416322&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fmicroblogging-about-newsworthy-events.html Many pharmaceutical corporate Twitter accounts are devoted to posting news about the company, including news about new research results relating to one of its products. In these tweets, product names are mentioned as well as the research results, but no fair balance information is included. Such tweets include links to press releases, which include all the necessary risk information.I am seeing a lot of these tweets and wonder if they violate FDA regulations.Back in October, 2009, I criticized such a tweet by Boehringer Ingelheim (BI), which I thought did violate FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). The tweet is shown below:In it's comments to the FDA, PhRMA, the US drug industry trade association, included a se... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3416322 Mon, 29 Mar 2010 12:00:00 +0100 3416322 http://www.medworm.com/index.php?rid=3395370&cid=t_371715_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FJic09r7RDqE%2Fwhat-content-is-pharma-responsible-for.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3395370 Mon, 22 Mar 2010 18:14:00 +0100 3395370 http://www.medworm.com/index.php?rid=3387051&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fconsumer-advocates-step-up-and-submit.html The deadline has come and gone for submitting comments to docket FDA-2009-N-0441 regarding "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." You can find ALL of the comments here at Regulations.gov and easily download MOST of them here at fdaSM.com. Unfortunately, the latter does NOT include text comments that were submitted by individuals. You can find these at the end of this post.Seventy (70) different entities submitted one or more comments to the docket. These submitters can be organized into the following eight general categories:HCP Org - Health Professional (HP) or HP AssnSearch Engine - Google and Yahoo!Trade Media - Blog, newsletter, publication focused on drug industry newsPharma Company - Drug, device, or diagnostic companyConsumer Advocat... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3387051 Sun, 21 Mar 2010 14:55:00 +0100 3387051 http://www.medworm.com/index.php?rid=3383079&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fdrug-companies-are-flocking-to-facebook.html More and more pharmaceutical companies are launching Facebook pages that promote their products. The latest is Allergan, which launched a celebrity Facebook campaign for Juvederm, a dermal filler used for "long-lasting correction of moderate to severe facial wrinkles and folds." Allergan also makes Botox.According to an MM&M story, "Ex-Extra host and broadcast journalist Dayna Devon will dispense personal tips to Facebook fans each week, and is sharing her experience with Juvederm through the social networking site."But why open up a Facebook page, which looks like just another product website (see screen shot below), especially if you are not going to accept and publish comments to the Wall?IMHO, Allergan and other pharma companies are not launching Facebook pages to "engage" consumer... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3383079 Thu, 18 Mar 2010 19:02:00 +0100 3383079 http://www.medworm.com/index.php?rid=3378726&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fjohnson-johnson-urges-fda-to-be-as.html In comments to the FDA, Johnson & Johnson (JNJ) stated "Flexibility in regulatory approach is crucial in the evolving digital world." The comment was part of an 8-page document submitted to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).JNJ especially would like FDA to be as flexible as the FTC in regards to disclosure of important drug safety information within the context of space-limited digital applications."Technology," says JNJ, "can help companies provide information about products in convenient and easily accessible ways, particularly for applications with limited space options. In such cases, links, rollover and scrolling functions can enable direct connections to safety and effi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3378726 Thu, 18 Mar 2010 14:12:00 +0100 3378726 http://www.medworm.com/index.php?rid=3378727&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fnovartis-proposes-use-of-unique-fda.html Novartis submitted 6 pages of comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).Novartis made many interesting proposals on how FDA should regulate the use of social media by drug companies, but I'd like to focus on one of particular interest to me: special FDA-sanctioned short URLs and hashtags that make it easy for consumers to find product-safety information and for the FDA to review social media communications for compliance. Novartis first recommended using a "new short URL, essentially a bit.ly for the FDA , that points to drug information on an FDA controlled website... Our recommendation is that the URL include mention of 'safe' or 'safety.' This website could then contain pr... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3378727 Wed, 17 Mar 2010 18:01:00 +0100 3378727 http://www.medworm.com/index.php?rid=3374373&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fshould-sanofi-aventis-submit-adverse.html Sanofi-Aventis (S-A) submitted 14 pages of comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here)."As part of routine monitoring of online discussions hosted, or with participation, by a company, postings that contain potential adverse event reports should be addressed according to established company policies and procedures for handling and reporting spontaneous adverse event reports according to current FDA regulations," said S-A in its comments. "This includes, when appropriate [my emphasis], to follow-up to obtain the necessary elements needed to report an adverse event."Considering the problems that S-A is experiencing on its VOICE Facebook page with regard to "disgruntled patient" S... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3374373 Wed, 17 Mar 2010 14:19:00 +0100 3374373 http://www.medworm.com/index.php?rid=3370666&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fyahoos-claim-that-patients-are.html Yahoo! submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).In defense of the "one-click rule" for space-limited "generic" search ads and "Rich Ads in Search (RAIS)," Yahoo! presented a study that purports to prove that "When it comes to side effects... the patient mindset appears to be ambivalent until research for an ailment is needed" (see Exhibit A (pdf)). The following chart was offered in evidence:The question, which was posed to 2,540 Online Americans in the study, was "As you may or may not know the FDA (Federal Drug Administration) mandates companies to lay out side effect information or risk factors in advertising. Using the scale below please tell us how much you ag... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3370666 Tue, 16 Mar 2010 17:30:00 +0100 3370666 http://www.medworm.com/index.php?rid=3370667&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fuse-of-internet-to-obtain-health.html This study was conducted between 2000 and 2002 and the researchers recognize that the Internet and access to it have changed dramatically since then, especially the rise of social networking resources. "The quality of health information and support online may have improved," say the researchers, "and Internet users today may no longer use Internet resources in the same fashion as they did during the time period of our study..."Perhaps if drug companies could more easily supply hopeful messages about effective treatments via the Internet, online health information seekers may be less depressed. Online health information seekers may even be the opposite of depressed -- ie, joyful -- if drug companies were to support open and authentic social networks where patients can exchange personal info... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3370667 Tue, 16 Mar 2010 11:25:00 +0100 3370667 http://www.medworm.com/index.php?rid=3335566&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fmerck-says-fda-should-approve-one-click.html Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of the “one-click rule” as it applies to space-limited digital product ads. For more background on the one-click rule, see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads."When FDA issued those infamous 14 notice of violation letters last spring, the drug industry was stunned and immediately pulled back from branded search engine advertising (see "The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!"). Apparently, Merck revise... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3335566 Thu, 04 Mar 2010 20:18:00 +0100 3335566 http://www.medworm.com/index.php?rid=3331602&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fastrazeneca-urges-fda-to-regulate-whole.html AstraZeneca (AZ) submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).Again and again throughout its comments to the FDA, AstraZeneca defends the concept that social media conversations by drug companies are just like real world conversations and should be similarly regulated; ie, FDA should consider the whole conversation, not just one part of it. "It is our view that the FDA, in developing its guidance, should view such participation in a manner analogous to its existing regulation of in person and telephonic promotional activities," said AZ. "In that case, the FDA examines not just one part of the conversation but the entire conversation as a whole.""It is similarly appropr... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3331602 Thu, 04 Mar 2010 14:33:00 +0100 3331602 http://www.medworm.com/index.php?rid=3327292&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fpfizer-asks-for-new-fda-regulations-not.html Pfizer submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).The world's #1 pharmaceutical company stands alone in calling upon the FDA to develop new regulations for the Internet and social media rather than issuing guidance that puts an "interpretative gloss" on existing rules."FDA should not try to fit the square peg of Internet and social media communications into the round hole of the Agency’s existing rules developed for conventional media," said Pfizer in its comments. "Rather, FDA should develop comprehensive new rules describing the actions manufacturers must take in order for their online communications to be truthful and non-misleading in the specific context of th... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3327292 Wed, 03 Mar 2010 12:42:00 +0100 3327292 http://www.medworm.com/index.php?rid=3322627&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fgoogle-defends-sidewiki-despite-fact.html Google submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).The search giant devoted about 3 pages to defending Sidewiki, which presents users with a vertical window on the left side of the web browser window, next to the relevant website, in which they can write and read commentary. I was one of the first people to use Sidewiki to attach comments to a drug.com website (ie, Viagra.com; see image on left; click for enlarged view).According to Google, "The service uses an algorithm to identify the best comments, based in part on user ratings, and seeks to display only comments that are judged to be of high quality." I am honored, therefore, that ALL of my sidewiki comments -- in... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3322627 Tue, 02 Mar 2010 17:10:00 +0100 3322627 http://www.medworm.com/index.php?rid=3322628&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fpatientslikeme-reports-high-rate-of.html  PatientsLikeMe (PLM) -- an online community for people with "life-changing conditions" -- submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here). The most interesting comments are about PLM's experience with adverse events reported by its members. In short, PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). This is 35 times the rate in the frequently cited Nielson study, which found only one such message in its random sample o... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3322628 Tue, 02 Mar 2010 13:30:00 +0100 3322628 http://www.medworm.com/index.php?rid=3318659&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Ffdasm-survey-results.html I worked all weekend to submit to the FDA the results of the Pharma Marketing News/Blog survey of readers about FDA's Regulation of Drug & Device Promotion via the Internet & Social Media. As you may recall, the FDA asked for comments relating to the following 5 issues:Issue 1: Accountability Issue 2: Fulfilling Regulatory Requirements Issue 3: Posting Corrective Information Issue 4: Links Issue 5: Adverse Event ReportingUnder each issue, the FDA included several specific questions for which it was seeking answers.Beginning on September 21, 2009, Pharma Marketing News/Blog hosted an online survey/ questionnaire that included all 19 of these specific questions. For most questions, the survey included specific choices that respondents could select as part of their answer. Each questi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3318659 Mon, 01 Mar 2010 16:17:00 +0100 3318659 http://www.medworm.com/index.php?rid=3302630&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Fwill-fdas-sm-guidance-resemble.html Yesterday, during a Pharma Marketing Talk live podcast/interview, Cynthia Phillips, who is currently Senior Director of Regulatory Labeling and Promotional Compliance at Millennium Pharmaceuticals, Inc., and spokesperson for an adhoc Social Media Working Group (SMWG), told how her group met with the FDA in October, 2009, and presented the agency with a draft guidance on regulating social media. This draft guidance may be similar to the comments SMWG submitted subsequently to the public docket (see "A Pharma 'Social Media Working Group' Submits Comments to FDA").Soon after its meeting with the SMWG, FDA held a public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.Back in October I said: "I think the preparations for ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3302630 Wed, 24 Feb 2010 12:44:00 +0100 3302630 http://www.medworm.com/index.php?rid=3283816&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Ffda-fan-club-launched-on-facebook.html "Should FDA have a Facebook page?," asks Mark Senak on his EyeOnFDA blog. "It is only a matter of time before Facebook, or some message platform equivalent, is realized as necessary."I decided that if FDA won't come to FaceBook, then FaceBook should come to FDA! To do that, I launched the official FDA Fan Club on FaceBook. Everyone who is a "fan" of the Food & Drug Administration is welcome to join and post their feelings about the FDA. Hopefully, this will help the FDA become a better organization by seeing what its "fans" have to say! Access the FDA Fan Club here: http://bit.ly/aRapuw (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3283816 Wed, 17 Feb 2010 17:57:00 +0100 3283816 http://www.medworm.com/index.php?rid=3262889&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Ffew-comments-submitted-to-fda-regarding.html Although the FDA opened a docket on September 21, 2009, for public comment on regulating pharmaceutical company drug promotion on the Internet and social media (see "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!"), only TEN (10!) comments have been collected as of January 28, 2010 (maybe one or two more after that). This was revealed by DDMAC's Jean-Ah Kang in an interview with IgniteHealth's fabio Gratton (see "A Conversation with DDMAC’s Dr. Jean-Ah Kang")."Right now," said Kang, "we already have the 77 presentations from the hearing and the ten or so comments that have been submitted to the docket as of today [1/28/2010]."At least 3 of those comments are mine! You can find all the comments on www.regulations.gov here.Meanwhi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3262889 Thu, 11 Feb 2010 14:27:00 +0100 3262889 http://www.medworm.com/index.php?rid=3259242&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Fwaiting-for-goduidance.html In ACT I of Samuel Beckett's play Waiting for Godot (rhymes with go) the character Estragon looks about and says to Vladimir, the other main character in the play: "Charming spot." (He turns, advances to front, halts facing auditorium.) "Inspiring prospects." (He turns to Vladimir.) "Let's go."Vladimir says: "We can't."Estragon: "Why not?"Vladimir: "We're waiting for Godot."I was reminded of this play while listening to a panel discussion yesterday at the 9th Annual ePharma Summit in Philadelphia. At least one panel member -- a pharmaceutical marketer who shall remain anonymous -- advised attendees not to wait for the FDA to publish its much anticipated guidelines regarding regulation of pharmaceutical marketing on the Internet and social media sites."If you are expecting clarity in any ki... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3259242 Wed, 10 Feb 2010 16:27:00 +0100 3259242 http://www.medworm.com/index.php?rid=3259253&cid=t_371715_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FCh5va9Rbe3Q%2Fepharma-summit-2010-steve-woodruff-of.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3259253 Wed, 10 Feb 2010 03:39:00 +0100 3259253 http://www.medworm.com/index.php?rid=3259254&cid=t_371715_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FogpdF0xPNNA%2Fepharma-summit-2010-guy-mastrion-on-how.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3259254 Wed, 10 Feb 2010 03:31:00 +0100 3259254 http://www.medworm.com/index.php?rid=3251392&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Ffda-blasts-lillys-pah-ecommunity-videos.html In a Notice of Violation letter to Lilly (see here), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly's drug approved for the treatment of Pulmonary Arterial Hypertension (PAH).The patient videos present statements made by Adcirca users, “Traci” and “Carolyn" who make the following claims among others:“I can walk, and stairs don’t bother me [after Adcirca treatment] . . . . Bending over used to make me breathless, picking up my cat used to make me breathless and it doesn’t affect me anymore.”“Exercising and stairs and heat used to bother me and it didn’t bother me anymore [after Adcirca treatment].”"Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial eviden... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3251392 Mon, 08 Feb 2010 17:18:00 +0100 3251392 http://www.medworm.com/index.php?rid=3228004&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Fnew-regulatory-wrinkle-cosmetic-doctor.html In what has been called a "first," the FDA "has cracked down on one of the most widely quoted cosmetic doctors, sending shudders through the ranks of opinion leaders in fashion publishing and vanity medicine," according to the New York Times (see here)."The F.D.A. recently sent a warning letter to Dr. Leslie Baumann, a well-known dermatologist and clinical researcher in Miami Beach, citing the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved," said the New York Times.FDA, in its letter, cited statements made by Dr. Baumann in newspapers and television that "clearly suggested that Dysport was safe and effective before it was approved, and that it was in fact superior to the approved product Botox because it... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3228004 Mon, 01 Feb 2010 16:56:00 +0100 3228004 http://www.medworm.com/index.php?rid=3228005&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F01%2Fpharma-social-media-working-group.html A group called the "Social Media Working Group" (SMWG) comprised of representatives from Amgen, AstraZeneca, Bristol-Myers Squibb, Millennium Pharmaceuticals, and sanofi-aventis U.S., recently submitted written comments to Docket No. FDA-2009-N-0441 (see here) regarding Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools. You can find the SMWG's comments here.Two significant things to keep in mind about the SMWG and its comments are: (1) the companies that are missing from the group (such as Pfizer, UCB, GSK, Merck, Novo Nordisk, etc.), many of which have engaged in social media, and (2) the non-binding nature of the suggestions made by the group; ie, "each representative of the SMWG continues to remain free to have independent opi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3228005 Sun, 31 Jan 2010 19:57:00 +0100 3228005 http://www.medworm.com/index.php?rid=3149315&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F01%2Fjapanese-cloth-company-trumps-merck.html With regard to new drug approvals in 2009, "Pfizer and Merck were among the big names that struck out for the year," says Peter Landers over at the WSJ Health Blog. Companies that did NOT strike out were four Japanese companies, including Teijin, a major textile maker!I was inspired by this story to create this cartoon:A note about Godzilla (from wikipedia):Godzilla is one of the most recognizable symbols of Japanese popular culture worldwide and remains an important facet of Japanese films, embodying the kaiju subset of the tokusatsu genre. He has been considered a filmographic metaphor for the United States, as well as an allegory of nuclear weapons in general. The earlier Godzilla films, especially the original Godzilla, portrayed Godzilla as a frightening, nuclear monster. Godzilla rep... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3149315 Thu, 07 Jan 2010 13:02:00 +0100 3149315 http://www.medworm.com/index.php?rid=3097061&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F12%2Finvestors-have-questions-about-pharmas.html Investors who own stocks or who are thinking of buying stocks of major online Health sites are worried. They have lots of questions about FDA's plans for regulating drug promotion on the Internet. As we know, when FDA regulates, markets react. When FDA sent out those 14 NOV letters, for example, branded paid search engine marketing by pharma experienced a "Prompt, Precipitous, & Prolonged" Plummet (see here). That could have been just a coincidence; I have heard that Google is worried about an overall decline in paid search engine advertising.Anyway, an Internet research team at a major regional brokerage and investment banking firm that provides investment advisory services to individual investors and professional money managers invited me to speak to some of their clients via conference ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3097061 Wed, 16 Dec 2009 19:54:00 +0100 3097061 http://www.medworm.com/index.php?rid=3089548&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F12%2Fwill-patients-find-value-in-discusions.html At the November, 2009, BDI Forum in New York City ("Healthcare Social Communications Leadership Forum Breakfast"), a question from the audience to a panel I was part of got to the core of the value of pharma to online patient communities. The question was "Should pharma be in discussion forums or lists frequented by patients? Do we need an industry consensus where we shouldn't go?"My colleague on the panel, Jonathan Richman (@jonmrich) noted that some consumer advocates speaking at the recent FDA public hearing said that under no circumstances should pharmaceutical companies be allowed to engage consumers in discussions on social networks. Jonathan thought that was too extreme. He suggested a few examples where such discussions could bring some value to the online patient community. He sai... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3089548 Tue, 15 Dec 2009 14:47:00 +0100 3089548 http://www.medworm.com/index.php?rid=3079576&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F12%2Ffinally-individuals-speak-out-pro-con.html The comments are dribbling in to FDA regarding whether or how it should regulate the use of the Internet by drug companies for promotion of its products. Either that, or www.regulations.gov, which is collecting the comments here, has a growing prostate problem that affects its information release "stream."Each week I will take a look at the site and see what new comments have been made public. You can find the first bunch here. I include a selection of the more juicy ones below. I especially focus on those submitted by individuals, most of whom are critical of pharmaceutical marketing and advertising. I do this because these voices were noticeably ABSENT from the "public" hearing in mid-November.Michael E. Bailey/individual:The manufacturers of medications and their representatives must be... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3079576 Fri, 11 Dec 2009 15:29:00 +0100 3079576 http://www.medworm.com/index.php?rid=3075714&cid=t_371715_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F12%2Fthe-fda-and-social-media.html Many of you know that the FDA held public hearings on the pharma industry’s use of Social Media mid-last-month.  There was much excitement going into this because to date, the FDA has pretty much dodged the subject, and left drugmakers in fear of retribution (see BusinessWeek’s summary here). Essentially, since there are no clear rules laid [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=3075714 Thu, 10 Dec 2009 13:00:02 +0100 3075714 http://www.medworm.com/index.php?rid=3067305&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F12%2Ftranscripts-of-fdas-november-2009.html You can find the transcripts here:Day 1 (November 12, 2009): PDF File, 507 pagesDay 2 (November 13, 2009): PDF File, 517 pages Enjoy! (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3067305 Tue, 08 Dec 2009 13:35:00 +0100 3067305 http://www.medworm.com/index.php?rid=3048342&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F12%2Fdear-fda-where-are-public-comments.html A public service message from FDA Intern:Not only does FDA Intern want to know where all the comments are, I want to know also! It's been over 2 months since the FDA called for comments and three weeks since the public hearing. But there are NO comments available to view on the www.regulations.gov docket here. There is ONE question that was submitted on September 22, 2009, but no comments. I submitted a comment this morning. It was the script and PowerPoint deck of the presentation I made during the first day of the public hearing. Here's the confirmation screen:My comment is not yet publicly available. When you submit a comment, you are warned that it may take "several weeks" for it to be available in the public docket. Why is that? I notice that Docket: FDA-2009-N-0294 (Regulation of Tob... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3048342 Wed, 02 Dec 2009 15:10:00 +0100 3048342 http://www.medworm.com/index.php?rid=3019229&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Ffda-intern-next-steps-toward-pharma.html Now that the big FDA public hearing is over, many people are asking "What's the next steps?" If you are like me, you expect FDA to issue new guidance. My friend John Murray has outlined the usual process FDA goes through when developing guidance here.But some of us are anxious to see if stakeholders can get more involved in the process. For example, does the FDA plan to pull in any outside consultants, or hire additional experts internally, to help craft the guidelines? There are other questions as well, like Will there be an additional comment period after draft guidelines are published?I learned that FDA Intern, strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even former FDA commish Andy von Eschenbach, is also on a ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3019229 Sun, 22 Nov 2009 17:32:00 +0100 3019229 http://www.medworm.com/index.php?rid=2842788&cid=t_371715_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fwhat-techniques-are-used-by-pharma-to.html In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.I am following the results of this survey closely and will provide updates. Here, I focus on this question:How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products??The survey asks respondents to choose one or more of the following responses (and/or add addi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2842788 Tue, 29 Sep 2009 11:44:00 +0100 2842788