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 'fda social media'. Sat, 03 Sep 2011 02:26:54 +0100 http://www.medworm.com/index.php?rid=5140306&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Fif-fda-published-social-media.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5140306 Tue, 16 Aug 2011 18:33:00 +0100 5140306 http://www.medworm.com/index.php?rid=5130723&cid=t_444307_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FxxtIfBchEDw%2F Social media can be a minefield for pharma companies given the FDA’s requirements to keep product information fairly balanced and promote only approved uses of drugs. Until now, Facebook has helped drug companies control the information on their sponsored pages by disabling the comment  function. That’s supposed to end today. As the Washington Post reports, most pharma pages — except those for specific prescription products — will now allow reader input. (The change doesn’t seem to completely be in effect yet.) “What [Facebook says] is that their philosophy is about promoting dialogue, and this wasn’t doing that,” Monique Levy, vice president of research at Manhattan Research, a pharma and health-care market research firm, tells the Health B... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5130723 Mon, 15 Aug 2011 19:11:39 +0100 5130723 http://www.medworm.com/index.php?rid=5029204&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F07%2Ffda-is-monitoring-this-blog-and-perhaps.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5029204 Fri, 08 Jul 2011 17:56:00 +0100 5029204 http://www.medworm.com/index.php?rid=5140270&cid=t_444307_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FIFO3oOfLaRU%2Fare-you-ready-for-impending-guidelines.html Are you prepared for the regulatory changes coming the digital marketing universe? Thomas Abrams, Director of DDMAC and previous speaker at the ePharma Summit has recently announced that they are closing in on regulation for social media. The digital marketing universe could change dramatically in the coming weeks and we've got the tools to help you adapt. ePharma Summit West brings together the best speakers from around the country to discuss the most important topics in digital marketing including mobile trends, best practices, patient engagement, sales force integration, physician interaction and of course regulatory. We give you all of this while providing you with hours of networking to meet new contacts and discuss the future of the industry. Download the brochure here. In additio... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5140270 Fri, 08 Jul 2011 13:56:00 +0100 5140270 http://www.medworm.com/index.php?rid=4945188&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Ftwelve-steps-of-pharma-social-marketers.html Welcome to Pharma Social Marketers Anonymous (PSMA)! You are among friends.Soon, you will take important steps on the path to overcoming your fear of social media. The first step is to admit you are powerless over social media and that your online life has become unmanageable.Are you ready to take ALL 12 steps toward recovery?Here are the Twelve Steps of Pharma Social Marketers Anonymous:I admitted I was powerless over social media—that my online life had become unmanageable.I came to believe that a Power greater than myself – innovative outside digital ad agencies – could restore me to sanity.I made a decision to turn my will and my online projects over to the care of the first social media agency that walked through my door and impressed me with their knowledge and experience,... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4945188 Wed, 15 Jun 2011 17:09:00 +0100 4945188 http://www.medworm.com/index.php?rid=4893911&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Ffda-drops-social-media-from-its-2011.html I just downloaded the "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2011" from the FDA site (find it here). Missing from this agenda is "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda (see here).However, included in the 2011 agenda under the Advertising Category is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet." Is this supposed to be the promised guidance we've all been waiting for? "Responding to unsolicited requests" is NOT a social media issue nor was it one of the questions FDA asked at the November 2009, public hearing (see all the questions here).I don't know who/what to believe. In February, 2... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4893911 Wed, 01 Jun 2011 12:37:00 +0100 4893911 http://www.medworm.com/index.php?rid=4762932&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F04%2Ffdas-proposed-web-study-will-further.html FDA has published in the Federal Register (click here) a series of proposed studies designed to test different ways of presenting prescription drug risk and benefit information on branded drug Web sites. This is BAD news for all us who have been waiting since November 2009 for the FDA to issues specific guidelines for use of the Internet and social media in promoting Rx drugs.In its proposal (find my highlighted, annotated pdf version here), the FDA states:"This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, a... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4762932 Thu, 28 Apr 2011 12:36:00 +0100 4762932 http://www.medworm.com/index.php?rid=4684754&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F04%2Fbrits-beat-fda-phrma-issue-social-media.html The Brits have won the race to issue social media guidance for the drug industry! (OK, it's NOT a race. Still, everyone says the EU regulators FOLLOW FDA's lead. Here's a case where the horse is following the cart!)The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published "informal guidance" providing the drug industry advice on how to use online communications.You can access the PMCPA "informal guidance" here.While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which "applies irrespective of the method of communication." NOTE: In contrast to the ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4684754 Tue, 05 Apr 2011 12:38:00 +0100 4684754 http://www.medworm.com/index.php?rid=4446010&cid=t_444307_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2Fywf9qx4kqTc%2Fepharma-2011-social-media-bootcamp.html Ray Chepesiuk, PAABThere are currently no FDA regulations, so how do you know what to comply to? For online, there are no published guidelines for online marketing. Pharma needs to be much better at self regulation while there are currently no guidelines from the FDA. Even though there are not guidelines, enforcement activities continue.Regulatory steps to social media and activities: the more complex the activity, the higher the value for the company. Should manufactures monitor the Internet for adverse events? If you can’t get all the information, your liability goes down. A company should have rules about who can engage and what sites they engage on. Regulatory rules are ones that help you succeed. If it is not appropriate in advertising or print media, it’s probably not appropriate... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=4446010 Mon, 07 Feb 2011 17:11:00 +0100 4446010 http://www.medworm.com/index.php?rid=4446030&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F02%2Fquestions-for-ddmac-director-thomas.html I've noticed that FDA's DDMAC Director Thomas Abrams has been making presentations at several recent drug industry conferences. At the 10th Annual ePharma Summit that begins today in New York City (see here), Abrams presentation is titled: "Regulation and Oversight of Prescription Drug Promotion: Update from DDMAC," which is similar to presentations he's made at other conferences.Of course, as I mentioned in a previous post ("11.5 Things I'd Like to Learn at ePharma Summit"), most attendees of the ePharma Summit are looking for updates on FDA's guidelines for use of the Internet and social media by pharmaceutical companies; ie, Where are they? When are they? What are they?From a preview of Abrams' Powerpoint presentation, it appears that he will have very little to say in answer to these q... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4446030 Mon, 07 Feb 2011 14:54:00 +0100 4446030 http://www.medworm.com/index.php?rid=4331233&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F01%2Ffda-says-there-are-no-simple-solutions.html In a reported issued last week by FDA's Transparency Task Force (see "19 steps FDA is taking to improve its transparency to regulated industry") the FDA took note of several comments it received stating that the timeliness of its regulatory guidance process must be improved; comments such as: “the process moves too slowly to provide meaningful information to industry."In response, the Task Force report says that "there are no simple solutions to such problems":"In part because of competing, sometimes higher-priority [my emphasis], demands on agency staff, there are no simple solutions to such problems as lack of predictability about when a guidance document will issue. For example, if application review, regulation development and crisis management are all given a higher priority than gu... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4331233 Mon, 10 Jan 2011 13:41:00 +0100 4331233 http://www.medworm.com/index.php?rid=4281549&cid=t_444307_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FldwRp15EWp8%2F The moment you have all been waiting for has been….delayed. Although the FDA indicated a year ago - after a widely publicized and closely followed meeting - that a guidance for social media would probably be issued by the end of this year, the agency is now officially postponing the debut until the first quarter of 2011. As Eye on FDA notes, the agency distributed an e-mail saying that “The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products: “Responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4281549 Wed, 22 Dec 2010 13:18:51 +0100 4281549 http://www.medworm.com/index.php?rid=4266213&cid=t_444307_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2Fbw0MjE1fwq4%2Fnew-policy-by-ama-aims-to-help-guide.html 90% of Americans are searching online for health information, but until recently, what they found tended to be jumbled and lacked credibility. Times are changing though. Mashable reports that as the health care revolution changes, many doctors, nurses and medical professionals are taking their insights online and offering patients credible resources to improve their health knowledge online.Both the AMA and the CDC has recognized this, and released Best Practice documents for those professionals. A few of the Best Practices that caught our attention were:Using privacy settings to safeguard personal information and content to the fullest extent possible on social networking sites. Routinely monitoring their own Internet presence to ensure that the personal and professional information on the... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=4266213 Thu, 16 Dec 2010 15:30:00 +0100 4266213 http://www.medworm.com/index.php?rid=4259194&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F12%2Fpharmas-2010-christmas-wish-list-for.html A few people helped me put together a short wish list for the US pharmaceutical industry to send to Santa this year (you can still vote or write-in your item to include on the list; see survey here).There are only 3 items on the list so far that merit Santa's urgent attention:(1) Left over from last year's list: Guidance from the FDA on how it will regulate drug promotion on the Internet and social networks. This, of course, is the most important item on the list. In last year's letter to Santa (find it here) pharma said: "Do I need to mention how much we would like guidance from the FDA on how it will regulate drug promotion on the Internet and social networks? Right now, we are really hurting because we cannot advertise on Google."Recently, a Time Magazine journalist interviewed me for a... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4259194 Tue, 14 Dec 2010 13:00:00 +0100 4259194 http://www.medworm.com/index.php?rid=4214456&cid=t_444307_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2Fr8b_JT2gs3Y%2Fwould-fda-care-if-kanye-west-said.html At the DIA in June the FDA said there would be guidance on social media practice by the end of the year. As we close in on December one has to ask, will we get any concrete guidance before the end of the year? In a brief but proactive post “Who’s Responsible for Tweets About a Drug?", Katherine Hobson discussed just this on the Wall Street Journal Health Blog this weekend. Ms. Hobson poses an interesting question regarding the industry’s responsibility with respect to what people post through Facebook, Twitter, etc. She wonders if the FDA would care if Kanye West or any celebrity’s comments on twitter would be the responsibility of the industry, in particular if they were paid to tweet it. It does beg the question, if a pharma company paid Kanye to suggest any drug was “better, f... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=4214456 Tue, 30 Nov 2010 19:00:00 +0100 4214456 http://www.medworm.com/index.php?rid=4125278&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F11%2Ffirst-internet-guidelines-from-fda.html There is much speculation as to when the FDA will publish its first guidance for the drug industry regarding promotion via the Internet and social media. At several recent conferences, FDA officials have stated that they expect to issue some guidance before the end of the year (2010) and will likely issue several guidances addressing specific questions that were addressed at the November 15, 2009 Part 15 public hearing (see "I Predicted It: Social Media Guidance Likely To Be Split Into Multiple Documents"). Recall that there were FIVE questions that the FDA asked the public to comment upon:For what online communications are manufacturers, packers, or distributors accountable?How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of i... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4125278 Mon, 01 Nov 2010 14:48:00 +0100 4125278 http://www.medworm.com/index.php?rid=3858377&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F08%2Fis-fda-playing-bait-switch-with-pharma.html Sensing that there are a lot of pharma marketers out there who are "angry as hell and don't want to take it any more," I decided to host a short, VERY anonymous survey seeking opinions about FDA's recent letter to Novartis regarding its use of metatag text in a Facebook Share button (for background,  see "Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget", "Who's in Charge of Your 'Invisible' Metadata? WARNING: Don't Invoke the 'Invisibility Rule'", and "Update on FDA Regulation of Pharma Metadata & Impact on Search").My timing could not have been better!Yesterday, the big story coursing through social media was NOT FDA v. Novartis, but the story of how JetBlue attendant Steven Slater decided he had had enough. He cursed off his passenger nemesis v... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3858377 Wed, 11 Aug 2010 11:32:00 +0100 3858377 http://www.medworm.com/index.php?rid=3831554&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F08%2Fwhos-in-charge-of-your-invisible.html My Twitter pals are all atwitter over FDA's recent letter to Novartis citing violative content in a Facebook "Share Widget" that Novartis created (see "Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget" for the back story).At the center of the controversy is "metadata." If you are a pharmaceutical marketer asking yourself, "What the hell IS metadata?", then you need to read this because some junior web developer on your team (internal or agency side) may be playing fast and loose with your metadata unbeknown to you and your legal/regulatory people. The Novartis letter is a warning that FDA, however, is looking at metadata.Metadata is usually "invisible" content inserted within the header of the HTML code that creates a Web page. This includes a "description... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3831554 Fri, 06 Aug 2010 13:11:00 +0100 3831554 http://www.medworm.com/index.php?rid=3761631&cid=t_444307_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FIb2gy5zIn1o%2Fnew-pharma-jobs-and-fda.html Pixels and Pills has been looking at new job opportunities in Pharma this week. Today's post focuses on potential jobs that could be developed in the FDA. Russ Ward suggests the idea of social media strategists in the FDA. Could this position stretch across lines and be found at the state and local level as well? What are some of the benefits we could see coming from state and local media strategists in the FDA? Read the full article here. (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3761631 Fri, 16 Jul 2010 16:05:00 +0100 3761631 http://www.medworm.com/index.php?rid=3676891&cid=t_444307_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=3468017&cid=t_444307_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=3416322&cid=t_444307_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=3395232&cid=t_444307_114_f&fid=34646&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FHealthCareBlogLaw%2F%7E3%2FTaOF1o1pUu8%2Fahla-teleconference-intersection-of.html On May 4, 2010, I will be participating in a teleconference on The Intersection of Social Media and Human Subjects Research. The teleconference is co-sponsored by the American Health Lawyers Association Health Information Technology, Life Sciences and Teaching Hospitals and Academic Medical Centers Practice Groups.The moderator for the teleconference will be Karl A. Thallner, Jr., Esquire, Partner, Reed Smith LLP, in Philadelphia, PA. The other panel presenters will be:Naomi Halpern, EsquirePartnerFrommer Lawrence & Haug, Washington, DCLaura Odwazny, EsquireSenior Attorney, Public Health DivisionOffice for Human Research ProtectionsOffice of the General CounselU.S. Department of Health and Human Services, Rockville, MDMore information, including a description of the program and how to ... Health Care Law Blog blogs http://www.medworm.com/rss/comments.php?id=3395232 Tue, 23 Mar 2010 16:29:27 +0100 3395232 http://www.medworm.com/index.php?rid=3370667&cid=t_444307_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=3331602&cid=t_444307_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=3322627&cid=t_444307_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=3318659&cid=t_444307_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=3269874&cid=t_444307_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FzXYgsB_QeJY%2Fepharma-summit-2010-christiane-truelove.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3269874 Fri, 12 Feb 2010 19:32:00 +0100 3269874 http://www.medworm.com/index.php?rid=3251398&cid=t_444307_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FnfW_qVVBygs%2Fpharmas-new-home-lies-at-corner-of.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3251398 Mon, 08 Feb 2010 14:00:00 +0100 3251398 http://www.medworm.com/index.php?rid=3167451&cid=t_444307_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FWzqFHO8U7n8%2Fcan-web-20-truly-improve-health-care.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3167451 Tue, 12 Jan 2010 21:39:00 +0100 3167451 http://www.medworm.com/index.php?rid=3067305&cid=t_444307_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=3019229&cid=t_444307_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=3004091&cid=t_444307_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FpsDmtedTMzI%2Fweb-seminar-insights-and-perspectives.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3004091 Wed, 18 Nov 2009 15:26:00 +0100 3004091 http://www.medworm.com/index.php?rid=2992849&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Ffda-social-media-guidelines-best-done.html In his closing remarks at yesterday's public hearing on FDA regulation of social media, Tom Abrams, Director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), said "what we have heard is it's a different medium."As far as I know, this is the first time that anyone at the FDA has said that. Usually, the FDA says it's "media-agnostic." In other words, its regulations apply to all media and do not have to be modified for any particular medium.I suspect that was just a defense for why the agency has not provided any specific guidelines for use of the Internet.In fact, the FDA HAS treated one particular medium as "different" in the past: TV.In 1997, for example, the FDA allowed direct-to-consumer (DTC) Rx ads on TV that did not include the complete approved physician... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2992849 Sat, 14 Nov 2009 14:42:00 +0100 2992849 http://www.medworm.com/index.php?rid=2992697&cid=t_444307_109_f&fid=34730&url=http%3A%2F%2Fpsychiatrist-blog.blogspot.com%2F2009%2F11%2Ffda-social-media-hearing-fdasm-word.html Twitter was awash with thousands of tweets (click link to left to read them) the past few days regarding the FDA's hearing today and yesterday about regulation of pharmaceutical marketing on the internet and using social media. Above is the word cloud for the tweetstream on the topic (minus all the references to fdasm, fda, RT, bit.ly, http, etc).If you want to dive deeper, check out the links on tr.im/hitlinks and on fdasm.com. A list of links to many of the presentations are available here. Public comments to the FDA are being accepted through Feb 28, so go to one of the above links to find the public comments page if you have something to say about this area. The controversies involve things like providing fair balance in 140 characters, making it easier to find plain English info on ad... Shrink Rap blogs http://www.medworm.com/rss/comments.php?id=2992697 Sat, 14 Nov 2009 02:00:00 +0100 2992697 http://www.medworm.com/index.php?rid=2989115&cid=t_444307_87_f&fid=34470&url=http%3A%2F%2Fwww.thehealthcareblog.com%2Fthe_health_care_blog%2F2009%2F11%2Fthe-fda-steps-in-regulating-prescription-drug-promotion-on-the-internet.html By KATE GREENWOOD The FDA has been widely criticized for not providing guidance for drug companies eager to promote their products on the internet. Earlier this year, the FDA expressed the view that the message was what was important, not... (Source: The Health Care Blog) The Health Care Blog blogs http://www.medworm.com/rss/comments.php?id=2989115 Thu, 12 Nov 2009 00:00:00 +0100 2989115 http://www.medworm.com/index.php?rid=2981131&cid=t_444307_109_f&fid=34730&url=http%3A%2F%2Fpsychiatrist-blog.blogspot.com%2F2009%2F11%2Fshrink-rap-grand-rounds-is-up-at.html The theme for crzegrl's Grand Rounds this week is Veteran's Day. The shrinky links:doctors & mistakes (Medicine & Technology)pharma ads & claims on twitter (HealthBlawg) ... also follow #FDAsm on Thur & Fri for coverage of the FDA's anticipated hearing on social media and Web2.0 (links for live streaming on HITshrink)antidepressants for chronic pain (How to Cope with Pain)love in the recovery room (Anesthesioboist) ... not really shrinky, just beautiful----- Listen to our latest podcast at mythreeshrinks.com or subscribe to our rss feed. (Source: Shrink Rap) Shrink Rap blogs http://www.medworm.com/rss/comments.php?id=2981131 Wed, 11 Nov 2009 16:00:00 +0100 2981131 http://www.medworm.com/index.php?rid=2981361&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Fim-off-to-fda-hearing-heres-what-i-plan.html I am scheduled to make two presentations at the November 12 - 13 FDA public hearing on the use of social media for Rx (and device) promotion:Presentation #1: Accountability, Fulfilling Regulatory Requirements, and Posting Corrective InformationDate: November 12, 2009Time: 9:30 - 9:45 AMPowerpoint Deck: http://www.virsci.com/JMack-FDASM-Slides_Part1.pdfTranscript: http://www.virsci.com/JMack-fdaSM-Presentation1transcript.pdfPresentation #2: Social Media and Adverse Event ReportingDate: November 13, 2009Time: 10:20 - 10:30 AMPowerpoint Deck: http://www.virsci.com/JMack-FDASM-Slides_Part2.pdfTranscript: http://www.virsci.com/JMack-fdaSM-Presentation2transcript.pdfYou can watch me and other presenters in a live webcast. Find information about that here.Keep up with what other presenters are do... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2981361 Wed, 11 Nov 2009 15:58:00 +0100 2981361 http://www.medworm.com/index.php?rid=2977565&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Ffda-panelists-at-upcoming-social-media.html Only the following 13 FDA panel members will be able to ask questions during this week's public hearing on the use of social media by the pharmaceutical industry:Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)Kathryn J. Aikin - Social Science Analyst, DDMAC - CDERRachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDERGerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDERKristin Davis - Deputy Director, DDMAC - CDERDavid J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the CommissionerEle Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation ResearchJean... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2977565 Tue, 10 Nov 2009 12:16:00 +0100 2977565 http://www.medworm.com/index.php?rid=2977566&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Fphrma-proposes-fda-approved-use-of.html In a telephone news briefing, PhRMA proposed an "FDA-Approved Use of Universal Safety Symbol" that could be used in branded/sponsored ad links (eg, Adwords) and Twitter posts (see image below).PhRMA says in its slide presentation (see here):Universal safety symbol (FDA logo or other FDA-approved symbol) and universal statement would indicate that the linked page contains FDA-regulated risk information (e.g., official Prescribing Information, patient Medication Guide)Throughout the Web, a universal symbol would help healthcare professionals and consumers identify official, FDA-regulated medical product Web sites. Prominence of graphic could drive clicks to comprehensive informationInclude established name and true abbreviated indication, if Internet media do not allow for full informationIn... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2977566 Mon, 09 Nov 2009 18:17:00 +0100 2977566 http://www.medworm.com/index.php?rid=2967531&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Ffda-public-hearing-deja-vu-all-over.html At eyeforpharma's eCommunication & Online Marketing Summit, the audience had a lot of questions about the upcoming FDA public hearing. At one point, the discussion turned to the nature of the speakers for this hearing versus the 1996 hearing. I prepared the following chart to illustrate the differences:There are some interesting differences, including:No representatives from search engines spoke at the 1996 meeting. Search wasn't a factor yet.There was good representation from healthcare professional groups (18%) in 1996. I'm talking about organizations like the AMA. This time there are no physician groups presenting. There's Sermo, but I count that among the health Web sites. This year there are far fewer pharmaceutical/device companies presenting than in 1996 when 21% of the speakers... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2967531 Thu, 05 Nov 2009 20:57:00 +0100 2967531 http://www.medworm.com/index.php?rid=2963329&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Fmy-fda-social-media-hearing.html As you no doubt know, FDA is hosting a public hearing on pharma's use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here):9:30-9:45 AM on Thursday, Nov 12 (following PhRMA)10:20-10:30 AM on Friday, Nov 13You can find my presentations here (warning: BIG pdf files):Part 1, covering FDA issues 1 (Accountability) & 2 (Fulfilling Regulatory Requirements)Part 2, covering FDA issues 3 (Posting Corrective Information) & 5 (Adverse Event Reporting)These presentations summarize most of the results to date of the ongoing survey I have been running since 20 September 2009 (find the survey here). The survey includes all 19 questions for which FDA seeks answers. There were 354 respondents as of 1 ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2963329 Thu, 05 Nov 2009 13:39:00 +0100 2963329 http://www.medworm.com/index.php?rid=2947138&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Findustry-groups-will-eat-consumer.html Speakers at FDA's upcoming November public hearing on social media have received the schedule of presentations, which you can find here.Each speaker has 10 minutes, but some -- like myself -- were given two 10-minute slots. As you may know, I will present results from the survey I have been hosting (see here). Why some of us got two slots, I don't know. I plan to address several questions put forward by the FDA and requested 15-20 minutes (see my proposal (pdf) here). I thought they would say 10 minutes and that's all you get! Instead, FDA gave me two 10-minute time slots. Nice of them. Fabio Gratton (@skypen) of Ignite Health, a marketing communications agency, sent me a spreadsheet that listed all the 55 unique presenters and characterized the services offered by each presenter's organiz... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2947138 Fri, 30 Oct 2009 18:39:00 +0100 2947138 http://www.medworm.com/index.php?rid=2934945&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fexpect-fda-social-media-draft-guidance.html Let me make a prediction: FDA's DDMAC will issue some version of draft guidance on the use of social medial for Rx drug/device promotion BEFORE the end of 2010. Just for the record, I tweeted about this last week (October 21, 2009; see here).Yesterday, at the ePatient Connections 2009 conference, I was a member of the Regulatory Panel that also included my friend Preeti Pinto, MS, MT (ASCP), Head of Medical Education and Regulatory Compliance at AstraZeneca, and Paul Loebach, Project Manager, DDMAC. I never met Loebach before, but I liked him even though he never fully revealed what he has been doing at DDMAC for the past 18 years. During that panel discussion, Loebach informed the audience that it was too late to request a seat at the upcoming November FDA public hearing on social media. ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2934945 Wed, 28 Oct 2009 12:13:00 +0100 2934945 http://www.medworm.com/index.php?rid=2902955&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fi-will-present-survey-results-at.html I just received confirmation from Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC in charge of Web 2.0 policy development, that I will be presenting the results of the survey "FDA's Regulation of Drug & Device Promotion via the Internet & Social Media" at the November 12-13, 2009 public hearing in Washington, D.C.To date, there have been over 250 responses to this survey. My goal is to have at least 350 responses by November. So, if you have not already taken the survey -- which seeks opinions on the 5 topics of interest to the FDA -- please do it now to get your opinion counted. Of course, you can also submit your comments directly to the FDA, but the survey is the only known instrument that allows a quantitative evaluation of specific solutions that address FDA's concerns.To respo... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2902955 Sun, 18 Oct 2009 13:01:00 +0100 2902955 http://www.medworm.com/index.php?rid=2890939&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fboehringers-branded-tweet-violates-fda.html Today marks another first for pharma's foray into the murky world of social media marketing. Boehringer-Ingelheim (BI), the German pharma company, just posted the following branded Tweet via Twitter:The link in that Tweet leads to this press release, which provides the details, including fair balance (eg, side effects).The press release also states:Please be advisedThis release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.About two-thirds of my Twitter followers are based in the U... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2890939 Wed, 14 Oct 2009 12:08:00 +0100 2890939 http://www.medworm.com/index.php?rid=2879801&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fare-there-special-cases-for-correcting.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:Should the parameters differentiate with regard to the prominence of the third-party site (i.e., readership), its intended audience (e.g., general public, health care professionals, patients), its intended purpose (e.g., personal diary, encyclopedia-type reference), and/or the author of the inf... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2879801 Sat, 10 Oct 2009 13:37:00 +0100 2879801 http://www.medworm.com/index.php?rid=2879802&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fhow-should-pharma-companies-submit.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 should companies address the potential volume of information shared on various social media sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable.The survey asks respondents to choose one or mo... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2879802 Fri, 09 Oct 2009 19:59:00 +0100 2879802 http://www.medworm.com/index.php?rid=2879803&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fshould-pharma-companies-correct-drug.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:Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?The survey asks respondents to choose one or mo... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2879803 Fri, 09 Oct 2009 18:16:00 +0100 2879803 http://www.medworm.com/index.php?rid=2876361&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fpharma-companies-should-have-public.html Discussions Not Independent of Pharma Influence? Survey says...3rd Party Dissemination of Altered Rx Drug Information on Social Media Sites. Survey says...Should FDA Regulation Depend on Specific Media or Audiences? Survey says... (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2876361 Thu, 08 Oct 2009 16:41:00 +0100 2876361 http://www.medworm.com/index.php?rid=2872052&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fregulatory-solutions-to-overcoming.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:Are there proposed solutions that may help address regulatory concerns when using social media tools associated with space limitations or tools that allow for real-time communications to present product information?NOTE: FDA has "regulatory concerns" primarily about over emphasis of benefits an... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2872052 Thu, 08 Oct 2009 11:24:00 +0100 2872052 http://www.medworm.com/index.php?rid=2872053&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fdoes-social-media-have-impact-on-public.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:Are there data to support conclusions about whether different types or formats of presentations have a positive or negative impact on the public health?NOTE: The FDA may be interested in other "formats" or "presentations" than those available through online social media (see comments below).The... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2872053 Wed, 07 Oct 2009 12:18:00 +0100 2872053 http://www.medworm.com/index.php?rid=2865914&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fpharma-prefers-1-click-rule-for.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 should product information be presented using various social media tools to ensure that the user has access to a balanced presentation of both risks and benefits of medical products?The survey asks respondents to choose ONLY one of the following responses (and add additional comments):No ma... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2865914 Tue, 06 Oct 2009 11:19:00 +0100 2865914 http://www.medworm.com/index.php?rid=2862749&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2F3rd-party-dissemination-of-altered-rx.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:With regard to the potential for company communications to be altered by third parties, what is the experience to date with respect to the unauthorized dissemination of modified product information (originally created by a company) by noncompany users of the Internet? The survey asks respondent... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2862749 Mon, 05 Oct 2009 11:09:00 +0100 2862749 http://www.medworm.com/index.php?rid=2857582&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F10%2Fwhat-criteria-determine-substantive.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:What parameters or criteria should be applied to determine when third-party communications occurring on the Internet and through social media technologies are subject to substantive influence by companies that market products related to the communication or discussion?The survey asks respondent... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2857582 Sat, 03 Oct 2009 16:09:00 +0100 2857582 http://www.medworm.com/index.php?rid=2855835&cid=t_444307_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2F3jFQKJshbLo%2Ffda-to-hold-hearings-on-social-media.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=2855835 Fri, 02 Oct 2009 18:43:00 +0100 2855835 http://www.medworm.com/index.php?rid=2839169&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fwho-should-be-responsible-for.html The FDA is asking for comments from the public about how it should regulate drug promotion on social network sites (see survey/questionnaire). Several of the questions FDA asks concerns the issue of monitoring, processing, and reporting adverse events that are found on social media sites (see here, here, and here). The pharmaceutical industry is concerned that the floodgates would open if it were responsible for reporting all the adverse events it encounters on social media.If only the FDA would not insist that manufacturers submit Adverse Event Reports (AERs), then all the industry's worries would be over. But how would FDA get this information? What about making physicians responsible for submitting all AERs?That's exactly what Miguel A. Tovar, journalist and author of Blogaceutics Blog ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2839169 Mon, 28 Sep 2009 14:12:00 +0100 2839169 http://www.medworm.com/index.php?rid=2836333&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fhow-is-adverse-event-information-from.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 is adverse event information from these sources being received, reviewed, and processed?The survey asks respondents to choose ONLY one of the following responses (and/or add additional comments):Special group within the company is responsible for receiving, reviewing, and processing AEs (In... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2836333 Sun, 27 Sep 2009 13:38:00 +0100 2836333 http://www.medworm.com/index.php?rid=2828459&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fget-your-fda-social-media-public.html If you are planning to attend the November 12-13 FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here and here), then you should order this T-shirt:I Went to FDA's Social Meeting Hearing & All I Got Was This Lousy T-ShirtHoping for Helpful Guidelines, but Not Expecting Anyby John MackAvailability: In stock. Usually ships within 24 hours. Order and pay for this T-shirt now using your credit card... ONLY $29.95 NOTICE: If you actually process this order, you will NOT get a T-shirt. But you WILL get "Social Media Pharma Marketing: Damned If You Do, Damned If You Don't?", a collection of reprints from Pharma Marketing News. Use discount code 'SMM444JM' to get a $17.00 discount! (Source: Pharma Mar... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2828459 Thu, 24 Sep 2009 14:01:00 +0100 2828459 http://www.medworm.com/index.php?rid=2820588&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fare-j-agents-trolling-for-adverse.html The FDA is interested in learning more about how pharmaceutical companies track adverse events on the Internet and have asked the public to submit comments in preparation of the November hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here and here).Specifically, FDA needs answers to these questions about social media/Internet and AE reporting: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?How is adverse event information from these sources being received, reviewed, and processed?What challenges are presented in handling adverse event information from these... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2820588 Tue, 22 Sep 2009 14:28:00 +0100 2820588 http://www.medworm.com/index.php?rid=2812563&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Flets-respond-to-fdas-questions.html On Friday, September 18, 2009, the FDA filed a notice to be published in the Federal Register on September 21, 2009 calling for a public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools:Docket No. FDA-2009-N-0441, CDER 200994. Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Notice of public hearing; request for comments). Public Hearing on November 12, 2009 And November 13, 2009 Comments due February 28, 2010. (See "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!")The FDA is requesting the public to submit comments to a series of specific questions, which are included... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2812563 Sun, 20 Sep 2009 16:02:00 +0100 2812563 http://www.medworm.com/index.php?rid=2741597&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F08%2Ftwitter-for-brands-beyond-marketing.html Yesterday, I posted one simple idea: pharmaceutical company employment of Twitter to notify patients about drug recalls, counterfeit drugs, or drug safety warnings (see "Twitter and Drug Safety: A Paramount Concern").There has been an interesting discussion in the comments to that post, including comments from representatives of Novo Nordisk and Johnson & Johnson. I also had some good reactions from my Twitter pals such as the following:RT @MaverickNY: RT @pharmaguy Pharma shld use twttr 2 warn patients abt drug recalls, counterfeits, warnings, etc. eg, Levemir... /Gr8 idea! (posted by @blogaceutics)@pharmaguy Really interesting perspective on Pharmaceutical Industry and Twitter. http://tiny.cc/kBP3U (posted by @askfrascoLiked: Twitter and Drug Safety: A Paramount Concern http://ow.ly/... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2741597 Fri, 28 Aug 2009 11:59:00 +0100 2741597 http://www.medworm.com/index.php?rid=2528157&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F06%2Facromegaly-answers-blog-raises.html My friend @skypen just Tweeted me this request: "John, interesting social media initiative by Tercica for niche patient community. Would love your thoughts." See his summary post "Compass launches blog and webinars for niche community."I'll focus on the Acromegaly Answers Blog, which "posts blogs from patients, caregivers, patient service specialists, nurses, doctors and others who live with and manage acromegaly every day." Ipsen, a global pharmaceutical "Group" based in France, sponsors this blog.According to MedAdNews, "Comments are approved by the med legal team and is moderated in collaboration between Compass and Ipsen regularly and checked at least once every 24 hours, usually every 12 hours, so that if there is any adverse events they can be reported in the appropriate timeframe."I... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2528157 Fri, 26 Jun 2009 16:42:00 +0100 2528157 http://www.medworm.com/index.php?rid=2442761&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F05%2Ffda-rules-are-not-media-agnostic.html FDA has just released a new draft guidance document: "Presenting Risk Information in Prescription Drug and Medical Device Promotion" (find the pdf file here).I haven't read the guidance yet, but according to a Reuters report, the guidance has some specific to TV ads:"Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers' comprehension of potential side effects, U.S. regulators advised in guidelines proposed on Tuesday."Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the Food and Drug Administration said."It seems to me that contrary to public statements by FDA officials and bloggers (eg, "FDA to Online Marketers: Same Rules Apply"), the same rules do NOT apply to all media.Obvious... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2442761 Tue, 26 May 2009 20:17:00 +0100 2442761 http://www.medworm.com/index.php?rid=2442762&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F05%2Flive-podcast-today-towards-rational-fda.html Arnold Friede, Counsel to the law firm McDermott Will & Emery LLP, talks about organizing a collective response from representatives of the pharma industry to FDA's recent enforcement initiative on the use of sponsored links in search ads and more generally, on FDA's overall approach to regulating social media and the Internet.Guest: Arnold I. Friede, Counsel to the law firm McDermott Will & Emery LLP Live Streaming Audio Date: Tuesday, May 26, 2009, 2 PM Eastern US time. Live Streaming Audio Duration: 15-20 minutesGo to this Pharma Marketing Talk Segment Page at the time indicated above to listen to the LIVE show via streaming audio on the Web. You will also be able to participate in an online chat with the host and speakers to ask questions! Background On April 2, 2009, the FDA i... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2442762 Tue, 26 May 2009 15:11:00 +0100 2442762 http://www.medworm.com/index.php?rid=2365442&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fwhat-good-can-come-from-public-fda.html "The reality of that actually happening is very small...""Does the public even want to talk with pharma companies?""If the FDA opened hearings to the public they would get an earful of what they don't want to hear or acknowledge...""Another reason the FDA is not going to get into social media as a marketing tool is that the evolution of social media is continuing at a very fast pace...""...at this time I'm sure the FDA wants to try and head to calmer waters.""With an anemic forecast for pharma sales for 2009 and more layoffs expected I also can't see pharma hiring more people to manage online social media initiatives."Wow! Fellow blogger Rich Meyer really dissed my call for a public hearing hosted by FDA on use of social media (or Internet in general) by pharmaceutical companies in his pos... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2365442 Thu, 23 Apr 2009 13:22:00 +0100 2365442 http://www.medworm.com/index.php?rid=2358889&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fhow-to-do-social-media-pharma-marketing.html That's my re-interpretation of Josh Bernoff's presentation "How to do a social application in life sciences without getting fired" at yesterday's Social Pharmer Boston Unconference organized by @Shwen.Bernoff is the co-author of the book "groundswell - winning in a world transformed by social technologies" and is Vice President and Principal Analyst at Forrester Research.Bernoff's title speaks to corporate politics. My re-interpretation tries to bring in the target audience of marketers -- especially consumers and patients. If not approached correctly, SM denizens can really "blow up" any marketer's carefully laid plans to engage them in conversation.Stuart Foster, an attendee of the SocPharm unconference, summed up Bernoff's presentation in his blog post:"It came down to this: Your custom... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2358889 Wed, 22 Apr 2009 11:50:00 +0100 2358889 http://www.medworm.com/index.php?rid=2349712&cid=t_444307_147_f&fid=38117&url=http%3A%2F%2Fwww.engageinhealth.com%2F2009%2F04%2Fdtc_national_wrapup.html The second and last days of the DTC National Conference in D.C. went by in a blur with several great presentations and many interesting people to meet. I tweeted nonstop, which you can review @emilydownward. Thursday included interesting presentations from Chris Schroeder at HealthCentral, John Gerzema, and a celebrity panel that included Jerry "the Beaver" Mathers, Deborah "Debbie" Gibson and former NFL champion Karl Nelson. Schroeder talked about how people are looking for health information in more specific terms, for example, they're not looking for "jogging" but "jogging on trampoline vs street." And data from HealthCentral shows that people who are finding content by these long-tail searches are 3-5 times more likely to interact with the advertisements on those pages. Referring to... The Health Engagement Blog blogs http://www.medworm.com/rss/comments.php?id=2349712 Mon, 20 Apr 2009 14:59:14 +0100 2349712 http://www.medworm.com/index.php?rid=2341860&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Ftwitter-lobbying-effort-calls-upon-fda.html The effort to get the FDA to hold a public hearing on the use of the Internet and social media for the promotion of drugs and medical products has moved onto a new stage: Lobbying legislators via Twitter (called "twilobbying")."John Mack's Saturday blog post, http://pharmamkting.blogspot.com/2009/04/fdas-actions-speak-louder-than-its.html, calls on the FDA to hold a public hearing on the use of the Internet and social media for the promotion of drugs and medical products," says Krū Research. "This is an excellent and reasonable request. And I’d make one other suggestion, send a tweet to all the Senators and Congressmen and women who are on Twitter. Maybe they 'get' social media better than the FDA and will see the sound reason of a request for a public hearing.""Get the full list of leg... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2341860 Mon, 13 Apr 2009 14:18:00 +0100 2341860 http://www.medworm.com/index.php?rid=2341865&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fphrma-says-fda-should-initiate-public.html "FDA should initiate a public process, which could take the form of a meeting or draft guidance, rather than regulating by warning letter in an area where there is now a lack of clear standards," said Jeffrey K. Francer, Assistant General Counsel, PhRMA.His comment was made during a recent 45-minute ePharma Pioneer Club conference call that I hosted. Several other ePharma Pioneer Club members, including Fabio Gratton, Jonathan Richman, Rich Meyer, and Rob Nauman were also on the call and had comments.The subject of the call was Overcoming Barriers to Pharma's Engagement in Social Networks. I expect a podcast audio archive to be available shortly.Meanwhile, here are the opening comments I made during the call:As all of you probably know, the FDA just sent off 14 letters to different pharmac... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2341865 Wed, 08 Apr 2009 18:51:00 +0100 2341865 http://www.medworm.com/index.php?rid=2301649&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fshould-fda-convene-public-hearing-on.html Discussion of Social Media Guidelines! No More Joking!") because it seems that the FDA and some pharma companies are "mulling" this over behind closed doors and I want those doors opened.What do you think?I have a survey to get your opinion, but first let me explain FDA's procedures for developing and issuing guidance documents, using its own words (see here for the Full Monty):What is a guidance document?"Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue.""Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2301649 Thu, 02 Apr 2009 16:57:00 +0100 2301649 http://www.medworm.com/index.php?rid=2301651&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Ffda-issues-first-ever-draft-guidance-on.html Discussion of Social Media Guidelines! No More Joking!").I had thought that the phrase "way cool" attributed to Jean-Ah Kang PLUS the links would have given it away.Unfortunately, a few people did not catch those hints. (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2301651 Wed, 01 Apr 2009 12:07:00 +0100 2301651 http://www.medworm.com/index.php?rid=2279767&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F03%2Ffda-widgets-how-about-one-for-adverse.html Fabio Gratton is at it again! He has started a poll, which asks "To all pharma marketers: A universal FDA Adverse Event widget required by all pharma websites (brand, disease, social) would be effective?"I assume he is following up on the "Tit-for-Tat Tithe" idea and that the widget he is proposing would allow visitors to pharma websites to easily report adverse events DIRECTLY to the FDA. This would lift the burden from pharmaceutical companies to track, investigate and report the adverse events themselves and free them up to focus on using social media sites for marketing purposes.Sounds like a good idea. What do you think? Take Fabio's poll here.Meanwhile, here are a few widgets developed by third parties that push out FDA information on drug safety topics. They are not interactive in t... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2279767 Tue, 17 Mar 2009 14:34:00 +0100 2279767 http://www.medworm.com/index.php?rid=2260912&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F03%2Freport-from-cbis-emarketing-forum_11.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2260912 Wed, 11 Mar 2009 20:04:00 +0100 2260912 http://www.medworm.com/index.php?rid=2182584&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F02%2Fyaz-commercial-yanked-from-tv-but-not.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2182584 Thu, 12 Feb 2009 14:01:00 +0100 2182584 http://www.medworm.com/index.php?rid=2125328&cid=t_444307_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F01%2Fnew-media-old-regulations-like-oil-and.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2125328 Thu, 22 Jan 2009 14:00:00 +0100 2125328