Replace information in brackets with relevant information on your productcompany. Guidance for industry internetsocial media platforms with character space limitations presenting risk and benefit. Oct 21, 2015 are you involved with influencer marketing campaigns. Fda issues proposed guidance for social media was added to your binder remove view my binder now add to binder on tuesday, the fda issued proposed guidance for the pharmaceutical and medical device industries for advertising on social media platforms with character space limitations and for correcting misinformation posted to social media. The fdas social media guidelines are here were they. Mar 14, 2018 the fda has guidance regarding the correction of misinformation about prescription drugs and medical devices on social media coming from independent thirdparties. This guidance is focused on social media tools and technologies that allow people to exchange information in real or delayed time on platforms that are public including but not limited to social networks such as facebook, micro blogs such as twitter, automated feeds such as rss, imagevideo sharing sites such as youtube. The companys communication should be relevant, responsive, limited, tailored, accurate, and non. Fda issues proposed guidance for social media jun 19, 2014. This guidance, which applies to all fda open advisory committee meetings or open portions of such. Promoting medical products globally baker mckenzie. The fda issued last month a draft guidance on regulatory requirements for postmarketing submissions to the fda of interactive promotional materials. For questions regarding this draft document, contact cder julie chronis at 3017961200 cber office of communication, outreach and development at 800.
Fda is mandated by law to regulate marketing of fda regulated products via social media. Internetsocial media platforms with character space limitations presenting. But it was not until december 2011 that the agency issued its first draft guidelines on social media. What i will cover legal issues involving fda regulation of social media fda guidance on social media fda actions involving social media best practices and other lessons 3 4. Recent fda social media marketing enforcement actions and the likely impact of social media promotion guidance by natasha f. If the findings support the fdas theory, the agency may not make any changes to the requirements contained in its guidance document. Its entirely possible that you missed the food and drug administrations fda officiously titled draft guidelines about social media marketing and communications. Preparing for an fda advisory committee meeting mddi online. Briefing book or briefing materials voisin consulting life sciences.
Fda issues two warning letters for social media use. Additionally, the policy provides guidance for fda employees and contractors to engage in social media in their personal capacity. Correcting independent thirdparty misinformation about prescription drugs and medical devices june 2014 this draft guidance is intended to describe fdas current thinking about how manufacturers, packers, and distributors firms of prescription human and. Documentation submitted to facilitate an agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. Apr 17, 2012 following the november hearing, the fda initially announced that it would issue guidance on social media by the end of 2010. In the document, the fda acknowledged that social media has led to the proliferation of content about pharmaceutical.
It does not create or confer any rights for or on any person and does not operate to bind. This seminar will help you understand in detail the application of fdas latest guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to fda regulation. While the fair balance requirement stems from the fdas regulations. As with fdas january 2014 draft guidance on fulfilling regulatory requirements for postmarketing submissions of interactive promotional media, however, the draft guidance on correcting misinformation advances a broad interpretation of when a company may be responsible for content on the web or social media, and more elaboration is needed to. Following the november hearing, the fda initially announced that it would issue guidance on social media by the end of 2010. Fda continues to delay release of guidance on social media use. The briefing package contains background information prepared by the food and drug administration fda for the panel members of the advisory committee. Fdas guidance covers the following internetsocial media platforms with character space limitations include online microblog messaging. But god bless you and your work, just begins to express my feelings. Nissen and colleagues using the fda briefing documents for the muraglitazar advisory committee meeting found. Internet and social media platforms correcting misinformation. How to ensure your social media content meets ftc, fda and. The guidance clarifies the difference between unsolicited and solicited requests in the social media realm. The value of briefing documents may be best illustrated by the first dual peroxisome proliferatoractivated receptor ppar agonist muraglitazar pargluva that was highly touted as a breakthrough by the professional and lay media.
After consideration, the fda announced that it would issue guidance on various aspects of social media by the end of 2010. Any information provided, no matter how brief, will need to. Social media and fda regulation for medical devices health. Zegarelli march 2014 in recent years, guidance by the u. For example, a question about offlabel use posted on a pharmaceutical companys web site, whether directed to the drug maker or others visiting the site, is an unsolicited request. A new draft guidance from fda explains how sponsors can submit a formal request for a meeting, which can be facetoface, teleconference videoconference meetings or written responses only, what sponsors should include in that request, how fda can respond, how long the agency can take to respond, and how the sponsor and fda can go about conducting efficient, consistent, timely and effective. In light of the confusion surrounding space limitations, fdas new guidance seeks to offer some black and white recommendations.
Jun 18, 2014 the second draft guidance details how prescription drug and device manufacturers, packers, and distributors should respond, if they choose to do so, to misinformation generated and distributed by independent third parties on the internet or through social media avenues. In 2009, fda issued guidance on presenting risk information about medical products and completely ignored social media and touched only lightly on the internet. The fdas social media guidelines are here were they worth. Social media, twitter and fda guidance forti publications. Jeanah kang internetsocial media platforms with character. It is difficult for marketers to know what is appropriate social media behavior because the fda has not provided much official guidance. The evolution of fdas social media guidancewhats next. Strategies for preparing for meetings with fda susan m. Fda releases social media guidance for promotion of. On january, 2014, the food and drug administration fda released a draft guidance document. The long awaited fda draft guidance on social media is probably not what many in the industry wanted. Article sharp slowdown in us fda new drug approvals in 2016. Nov 12, 2009 the value of briefing documents may be best illustrated by the first dual peroxisome proliferatoractivated receptor ppar agonist muraglitazar pargluva that was highly touted as a breakthrough by the professional and lay media. The internet and various social media platforms have increasingly.
Jan 23, 2014 the long awaited fda draft guidance on social media is probably not what many in the industry wanted. Draft guidance provides the medical industry with long awaited boundaries for marketing in the electronic age. This guidance document is being distributed for comment purposes only. The fda just unveiled its new social media policy, which provides guidance to their employees on use of social media for official and personal purposes. Food and drug administration fda or agency for industry on the use of social media has continued to evolve in incremental. Formal meetings between the fda and sponsors or applicants. May 25, 2017 according to the fda guidance, when you use social media, you need to include the good, bad and the ugly about your product. Fda releases social media guidance for promotion of prescription drug and medical device products. In other words, its a draft guidance on which of the materials that a company intends to use on social media and similar platforms should be filed with the fda and how and when to do so. The most important aspect of this guidance is that fda is including social media in its discussions. Stay current, we suspect fda will release guidance specific to social media sometime in 2011. It does not make doing social media easier or provide more options to creatively use new media.
The importance of fda approval packages and briefing. Fda guidance for industry internetsocial media platforms. Report the post at the time of initial display, then if you remain active in the conversation, report it in your monthly list to the fda. To be clear, the document is not comprehensive social media guidance, rather, it is another in a series of guidance documents addressing the everchanging world of dynamic digital and social communications. Apr 26, 20 fda continues to delay release of guidance on social media use. Communicating the brand name and scientific name, benefits, risks, and a hyperlink is perhaps unreasonable within 140 characters, despite fdas examples. This paper first explores the history of social media, its use by the fda, and its growing use by the pharmaceutical industry. Recently fda has published two guidance documents specifically addressing its recommendations for best practices for social media marketing and several more are believed to be in the works.
Recently released fda social media guidance for the life sciences industry by amy k. Prescription drugs and medical devices draft guidance. On tuesday, the fda issued proposed guidance for the pharmaceutical and medical device industries for advertising on social media platforms with character space limitations and for correcting misinformation posted to social media platforms by third parties. Drug companies wait for fda guidelines on social media. The fda released a longawaited social media policyand it. Saying thank you does not seem to be strong enough. Fda guidance for pharma on social media and offlabel use. Data is hashed deidentified, and hashed data of advertiser and social media service is compared. It essentially is a guide to what content a drug company is responsible for and when it is not responsible. According to fda appropriate corrective action by a company should.
Fda recognizes that employees have the right to use social media to express personal views, and says that it encourages employees to use social media to share information that may benefit the public health. Fda guidance documents regarding advertising and promotion. Learn how to spot issues or get help making sure you are in compliance. However, the agency reminds employees of the following. Fda guidance on the use of social media is starting to. Fda issues new draft guidance on submitting formal meeting. Recent fda social media marketing enforcement actions and.
According to the fda guidance, when you use social media, you need to include the good, bad and the ugly about your product. Use the provided template to submit a briefing book bb to nice scientific advice sa in microsoft word format. Social media, twitter and fda guidancesprescription drugs and medical devices fda just released on june 17 two important draft guidances for the fda regulated industry specific to prescription human and animal drugs and medical devices for humans. As noted at the outset of this guidance, fda will take a flexible, adaptive approach to. While any information regarding social media use for pharma at this point is appreciated, the fdas recent published guidance regarding offlabel use leaves a conservative industry with even more qualms about using social media for interaction and information sharing. Fda issues two draft guidance documents relating to. As discussed above, true drug labeling the pi is an fdaapproved document that always.
Oct, 2014 it is difficult for marketers to know what is appropriate social media behavior because the fda has not provided much official guidance. Jul 09, 2014 the first guidance document internetsocial media platforms. The path forward 02102012 in december, the fda released the first of its longawaited social media guidances. Guidance for industry food and drug administration. If there is a match, the social media platform delivers the ad to the user. This guidance represent s the food and drug administration s fda s current thinking on this topic.
Social media and fda regulation for medical devices. In 2009, the fda expressly stated that it planned to develop and issue guidance on the use of social media. Briefing book guidance for company general points for preparing a briefing book. Include a separate document for each site which includes. The fda released a longawaited social media policyand its. The fda has guidance regarding the correction of misinformation about prescription drugs and medical devices on social media coming from independent thirdparties. Food and drug administration fda continued to outline its.
Fda draft guidance on social media dtc perspectives. The person also is a registered user of a social media service. Fda is mandated by law to regulate marketing of fdaregulated products via social media. Correcting independent thirdparty misinformation about prescription drugs and medical devices describes how fda believes manufacturers, packers, and distributors of prescription drugs and medical devices should respond to misinformation either positive or negative about. Feb 16, 2016 this guidance is focused on social media tools and technologies that allow people to exchange information in real or delayed time on platforms that are public including but not limited to social networks such as facebook, micro blogs such as twitter, automated feeds such as rss, imagevideo sharing sites such as youtube. Fdas brief, firstever, social media guidance for marketing. Your social media posts need to be fair and balanced. Social media is undoubtably a fundamental part of advancing public healthpart of the fdas core mission. Article the drug quality and security act is the fda walking. Fda tightly regulates pharmaceutical advertising, and currently companies are required to submit to the fda every promotional document. This is a significant departure from just a few years ago. Institute for social research, the university of michigan. The evolution of fdas social media guidancewhats next pm360.
Sep 19, 2015 fda guidance for industry internet social media platforms. Fda releases draft social media guidance covers interactive promotional media, such as facebook, twitter and blogs the fdas justreleased draft social media guidance has been more than four years in the making but finally looks to offer industry some substantial direction on its use of digital media. Ever since fdas 2009 hearings on the internet and social media platforms, industry has been anxiously awaiting guidance from the fda on the proper use of social media to promote approved products. Correcting independent thirdparty misinformation about prescription drugs and medical devices june 2014 this draft guidance is intended to describe fda s current thinking about how manufacturers, packers, and distributors firms of prescription human and animal drugs drugs and medical devices for human use devices should respond. Now fda is out a new social media draft guidance document, internetsocial. While this guidance does provide some clarity regarding fda s expectations about companies character limited promotions, the guidance will prohibit many companies from using social media. Communicating the brand name and scientific name, benefits, risks, and a hyperlink is perhaps unreasonable within 140 characters, despite fda s examples. Guidance regarding social media tools national institutes.
Recently, fda released two draft guidance documents on the promotion of prescription drugs and medical devices on the internet and social media. Fda guidance on using social media virtually nonexistent. Are you involved with influencer marketing campaigns. Food and drug administration fda regulates the promotion of prescription drugs. Through this webinar, participants will learn how to navigate fdas interpretations and expectations about a firms marketing practices through social media. Use social media, but follow the general fdca regulations and existing dtc guidance. While this guidance does provide some clarity regarding fdas expectations about companies character limited promotions, the guidance will prohibit many companies from using social media. A substantial portion of points came from its distinction between official and personal use of social media, and notably, the freedom it gives to its employees on the latter. Contents of briefing package relevant guidance documents and regulations. The process can be supplemented by information from data brokers for more refined ad targeting. The fdas position on social media by dr nicola davies. Social media and fda regulation for medical devices social. With the fda social media policy completed, we now have in place a full process for fda communicators to request social media channels in which to engage the public, based on sound strategy.