PF
Emerging Technologies Librarian for the Health Sciences, University of Michigan
Caring for those with Dementia and Alzheimer's. FlowingData | Data Visualization and Statistics. Many Eyes. Cool Visualizations - Tecniche di visualizzazione dei dati.
Visualization. Twitter. How Far Did Your Tweet Travel? What the Hashtag?! - the user-editable encyclopedia for Twitter. #FDASM: Tweets, Blogs, and News Regarding the FDA Hearings on In. #FDASM: Tweets, Blogs, and News Regarding the FDA Hearings on In. Public Hearing on Promotion of FDA-Regulated Medical Products Us. National Transportation Safety Board Conference Center 429 L’Enfant Plaza, SW., Washington DC, 20594 The Food and Drug Administration (FDA) will hold a public hearing to provide an opportunity for broad public participation and comment on promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry.
This meeting and written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. Hearing Date: November 12 and 13, 2009 Time: 8:00 a.m. to 5:00 p.m. each day. Regulations.gov. FDASM_ARTICLES. FDASM. How to Do Social Marketing in Heavily Regulated Industries - Cli. Augustine Fou | October 22, 2009 | 11 Comments inShare0 Financial services, pharmaceutical, and healthcare are ripe for social marketing. Here's why. Conventional wisdom would probably say that social marketing is impossible in industries like financial services, pharmaceutical, and healthcare due to heavy regulations and requirements for disclosure.
More specifically, in the pharmaceutical industry there exists a regulation that requires companies to report "adverse events" to the Federal Drug Administration within 72 hours of "hearing" it. Conventional Wisdom Is Not Wise We'll argue that this conventional wisdom isn't wise at all. Another example where conventional advertising "wisdom" no longer applies is advertisers who are still desperately seeking reach and frequency (how many consumers can be beat over the head with ads and how often). Traditional Regulations Apply to 'Push' Advertising Techniques Social Marketing Is a 'Pull' Technique It's the only option.
Pharma 2.0: Whats a Brand Marketer to Do? Pharma and Healthcare Social Media Wiki. Eighty-Sixing Free Speech - 05/13/2009 - The Burrill Report. The Burrill Report “Where is the European media’s outrage on this ruling? And what will we hear from their American cousins?” According to a new European Court of Justice ruling, information about medicines produced by third parties such as journalists may constitute advertising, even though they have no connection with the product’s manufacturer or marketer. For those in the United States who believe in the First Amendment, this is quite startling news.
The European Court of Justice cited Article 86 of European Union Directive 2001/83/EC, which defines the concept of medicines advertising. Moreover, the court added, such “advertising…is liable to harm public health,” even when it is carried out by “an independent third party outside any commercial or industrial activity” (such as journalists, or patient groups, or doctors). Mr. Mr. The Danish Regional Court of Appeal then referred the case to the European Court of Justice for a preliminary ruling. Peter J. Greetings From the FDA Hearings on Social Media. As I’ve mentioned before on this blog, though healthcare companies (like Johnson & Johnson) would like to take a more active role in the ongoing conversations online, most are still sitting on the sidelines.
Why? Well, there are a number of reasons, but one of the biggest is that there is quite a bit of uncertainty about just what is appropriate under the current regulatory framework. It’s all rather complicated, but in the US a lot of the uncertainty around how to engage online concerns how companies that sell highly regulated prescription medications and medical devices can do so and still meet their regulatory requirements to 1) report any side effects that people may experience while taking their products and 2) to ensure they don’t promote their products beyond what is covered in their approved product label.
This uncertainty has not gone unnoticed, and for the past two days the FDA has held a hearing on the subject. Hearing this theme come up again and again made me smile. The FDA Grapples with Rules for Social Media - 11/20/2009 - The. The white elephant in the room: the FDA hearing and DTC - whydot. The FDA hearing on social media took place almost a month ago already and a lof of ink (or pixel for that matter) has flown since on what was presented. I vividly encourage you to dig through the sources on Fabio Gratton ‘s excellent #fdasm site to paint your own picture of the content. In my simplistic view, however, I would classify the presentations on proposed guidance at the hearing into three categories: 1.
Enable direct to consumer advertising (DTC) via social media- by allowing links to fair balance and safety information (“one-click rule”) 2. 3. Yet, after having gone through most of the great content from the hearing as well as through reactions afterwards, I much regretted the little amount of e-patient input. Why was this? I came across this discussion initiated by Lisa Emrich , one of my favorite MS bloggers and an incredibly sharp thinker. Patients have been turned off by years of abusive DTC TV ads and despise the idea of it leaking into their social media haven. Donna R. Pharmas Propose Solutions for Web Ad and Social Media Regulation. Kate Kaye | November 13, 2009 | 0 Comments inShare0 Pharma brand logos and an icon symbolizing approved health information were among ideas for regulating drug marketing online proposed at yesterday's FDA hearing. Pharmaceutical company logos and an icon symbolizing government-approved health related information are among the proposed ideas for regulating drug marketing online.
Firms including Yahoo, WebMD, and Sanofi-Aventis were represented at yesterday's Food and Drug Administration hearing on the topic. Most stressed the need for clear guidance from the FDA on how to market online, particularly when it comes to interacting with consumers in social media environments. The two-day hearing, held in Washington, DC, serves as a forum for interested industry parties to air their concerns and propose ideas for regulations. Many pharmaceutical brands have remained hesitant to advertise online or experiment with social media due to unclear FDA guidance.
Pharma, Don’t Be Shy about Social Media | ePharma Rx. So the hullabaloo over the FDA hearing on regulated industries’ use of the Internet and social media is dying down a bit. It’s been a month, so I guess that’s normal. I got caught up in other stuff and didn’t get a chance to do a wrap-up, but that’s okay, because about 3,467 other people did. Just visit or search Twitter for hashtag #fdasm and you’ll have more reading, reports, and recaps than you’ll know what to do with. The noise is dying down.
But it’s not over. Not even close. As you’re securing budgets, reviewing your 2010 plans, and wondering if you’ll have to put any social media on hold, think again. Don’t be paralyzed. Frustrated that it may be a year or more before FDA issues guidelines? The Rules as We Know ThemLike it or not, here are the rules we have to work with today: Same rules apply. "Doing" Social Media in Today's Environment Make sure you’ve laid the foundation. Common Sense: Perspective on the FDA Social Media Hearing. The FDA has completed a two-day Part 15 Public Hearing titled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools”.
A total of 76 presentations were heard by a packed room and large webcast audience. This phase of the public hearing will continue until February 28, 2010, which is the last day to submit public testimony. The current thinking is that guidelines could emerge as early as Summer, 2010, although no formal commitment to a timeline has been given. The tenor of the presentations was quite clear. It is time to figure out how manufacturers can engage directly with customers online.
So, out of 76 presentations, here’s a “cut through the clutter”. Part I #1 – If you correct information online, are you responsible for the full conversation? #2 – What is the Most Effective Way to Share Safety Information? #4 -- How much identifiable criteria must be there to report an AE? Part II How the World Has Changed All the best, Bob. Perplexitypeccable's Channel.
John Kamp of the AAAA on Advertising, the FDA Hearings, and Soci. Eyeonfda's Channel. Eyeonfda (eyeonfda)
Help. Cool stuff.