The Public Relations Society of America and the Word of Mouth Marketing Association filed joint comments with the U.S. Food and Drug Administration concerning guidelines for pharmaceutical companies' use of social media.
The Public Relations Society of America (PRSA) sent a letter to the Senate Subcommittee on Contracting Oversight urging it to avoid actions that might diminish or severely restrict the U.S. government’s use of approved public relations and public affairs contractors.
Moderator Jackie Taylor and Panelists Ben Merrion, Eric Nesheim, and JoAnn Weinberger, explore strategies their state / district organizations have found effective in raising awareness of adult education and literacy.
The Public Relations Society of America (PRSA) sent a letter to the Senate Subcommittee on Contracting Oversight urging it to avoid actions that might diminish or severely restrict the U.S. government’s use of approved public relations and public affairs contractors.
Moderator Jackie Taylor and Panelists Ben Merrion, Eric Nesheim, and JoAnn Weinberger, explore strategies their state / district organizations have found effective in raising awareness of adult education and literacy.
This presentation focuses on the status of adoption of social media by corporate investor relations departments in U.S. public companies. It was delivered on October 2, 2009, by Dave Hogan, APR, at the annual conference of the International Association of Online Communicators (IAOC) in Washington, D.C.
Leveraging Social Media for Healthcare ProvidersGreenway Health
Eighty-one percent of Americans look for health information online- but from whom are they getting it? Social media gives providers the opportunity to influence the information their patients are reading online and to engage them in a meaningful conversation. Learn how to utilize these technologies to improve patient communication, outcomes and even your bottom line.
Redbeacon Launch Announcement - March 2010ethananderson
This is the presentation given to the media on Redbeacon's new Friendly Advice feature that allows users to invite their Facebook friends to give advice on which service professional to choose for their job. It also announces Redbeacon's strategic partnership with BigTent, a leading provider of parents clubs websites.
How to use the Power of Social Media in the Pharmaceutical Industry.pdfdnyaneshwarivedpatha1
Impact of COVID-19 on Social Media Engagement
The outbreak of the COVID-19 pandemic in 2020 brought about significant shifts in online behavior, particularly in the pharmaceutical sector. With national lockdowns and social distancing measures in place, people turned to social media as a primary source of information, entertainment, and connection. The average user spent more time than ever on social media platforms, seeking news updates, community support, and healthcare guidance.
Importance of Understanding Regulatory Landscape
Amidst this digital evolution, it’s crucial for pharmaceutical companies to navigate the regulatory landscape effectively while leveraging the power of social media. Regulations play a vital role in ensuring ethical practices, accuracy of information, and protection of consumers’ health and privacy. Therefore, understanding and adhering to regulatory guidelines is paramount for pharmaceutical organizations engaging in social media marketing.
This blog will delve into the intersection of social media marketing and regulatory compliance within the pharmaceutical industry, highlighting key guidelines, best practices, and the evolving landscape shaped by global trends and pandemic influences.
Evolution of FDA Regulations
Historical Restrictions on Pharmaceutical Content
In the early days of social media, pharmaceutical companies faced stringent restrictions on the type of content they could share online. The FDA’s regulatory framework, aimed at ensuring public safety and preventing misleading information, posed challenges for marketers in the pharmaceutical sector. Companies had to navigate complex rules regarding the promotion of prescription drugs, including limitations on discussing specific drug benefits and risks in online platforms.
Changing Landscape and Updated Regulations
Over time, the landscape of social media marketing in the pharmaceutical industry has evolved significantly. Regulatory bodies like the FDA have recognized the growing influence of digital platforms and the need for updated guidelines that strike a balance between promotional activities and regulatory compliance. This shift has led to the revision of regulations and the introduction of updated guidelines tailored to the digital era.
The FDA, in collaboration with industry stakeholders, has issued guidance documents and updates to help pharmaceutical companies navigate social media marketing responsibly. These guidelines address key areas such as fair balance in promotional content, disclosure of risk information, handling of adverse events, and engagement with online communities. The changing regulations reflect a broader acknowledgment of the importance of digital communication channels in healthcare information dissemination.
Importance of Compliance Amidst Evolving Regulations
Compliance with regulatory requirements is paramount for pharmaceutical companies operating in the social media landscape. As regulations evolve
The thoughts of patients, health advocates, former government officials, bloggers and others who participated in a roundtable discussion that AstraZeneca convened in 2010.
This presentation focuses on the status of adoption of social media by corporate investor relations departments in U.S. public companies. It was delivered on October 2, 2009, by Dave Hogan, APR, at the annual conference of the International Association of Online Communicators (IAOC) in Washington, D.C.
Leveraging Social Media for Healthcare ProvidersGreenway Health
Eighty-one percent of Americans look for health information online- but from whom are they getting it? Social media gives providers the opportunity to influence the information their patients are reading online and to engage them in a meaningful conversation. Learn how to utilize these technologies to improve patient communication, outcomes and even your bottom line.
Redbeacon Launch Announcement - March 2010ethananderson
This is the presentation given to the media on Redbeacon's new Friendly Advice feature that allows users to invite their Facebook friends to give advice on which service professional to choose for their job. It also announces Redbeacon's strategic partnership with BigTent, a leading provider of parents clubs websites.
How to use the Power of Social Media in the Pharmaceutical Industry.pdfdnyaneshwarivedpatha1
Impact of COVID-19 on Social Media Engagement
The outbreak of the COVID-19 pandemic in 2020 brought about significant shifts in online behavior, particularly in the pharmaceutical sector. With national lockdowns and social distancing measures in place, people turned to social media as a primary source of information, entertainment, and connection. The average user spent more time than ever on social media platforms, seeking news updates, community support, and healthcare guidance.
Importance of Understanding Regulatory Landscape
Amidst this digital evolution, it’s crucial for pharmaceutical companies to navigate the regulatory landscape effectively while leveraging the power of social media. Regulations play a vital role in ensuring ethical practices, accuracy of information, and protection of consumers’ health and privacy. Therefore, understanding and adhering to regulatory guidelines is paramount for pharmaceutical organizations engaging in social media marketing.
This blog will delve into the intersection of social media marketing and regulatory compliance within the pharmaceutical industry, highlighting key guidelines, best practices, and the evolving landscape shaped by global trends and pandemic influences.
Evolution of FDA Regulations
Historical Restrictions on Pharmaceutical Content
In the early days of social media, pharmaceutical companies faced stringent restrictions on the type of content they could share online. The FDA’s regulatory framework, aimed at ensuring public safety and preventing misleading information, posed challenges for marketers in the pharmaceutical sector. Companies had to navigate complex rules regarding the promotion of prescription drugs, including limitations on discussing specific drug benefits and risks in online platforms.
Changing Landscape and Updated Regulations
Over time, the landscape of social media marketing in the pharmaceutical industry has evolved significantly. Regulatory bodies like the FDA have recognized the growing influence of digital platforms and the need for updated guidelines that strike a balance between promotional activities and regulatory compliance. This shift has led to the revision of regulations and the introduction of updated guidelines tailored to the digital era.
The FDA, in collaboration with industry stakeholders, has issued guidance documents and updates to help pharmaceutical companies navigate social media marketing responsibly. These guidelines address key areas such as fair balance in promotional content, disclosure of risk information, handling of adverse events, and engagement with online communities. The changing regulations reflect a broader acknowledgment of the importance of digital communication channels in healthcare information dissemination.
Importance of Compliance Amidst Evolving Regulations
Compliance with regulatory requirements is paramount for pharmaceutical companies operating in the social media landscape. As regulations evolve
The thoughts of patients, health advocates, former government officials, bloggers and others who participated in a roundtable discussion that AstraZeneca convened in 2010.
Navigating FDA’s Social Media Guidelines for Medical Devices.pdfdnyaneshwarivedpatha1
Ensuring Regulatory Compliance and Monitoring in Medical Device Marketing
Compliance and Monitoring
FDA’s Stance on Continued Monitoring of Third-Party Websites and Social Media Platforms
The FDA emphasizes the importance of continued monitoring of third-party websites and social media platforms by medical device companies. This monitoring helps ensure that information related to their products remains accurate, up-to-date, and compliant with regulatory guidelines. Companies are responsible for actively monitoring user-generated content and addressing any misleading or inaccurate information promptly.
Non-Objection to Voluntary Corrections Meeting FDA’s Recommendations
The FDA encourages voluntary corrections by medical device companies to address misinformation or inaccuracies in their marketing materials. When companies take proactive steps to correct such information in line with FDA’s recommendations, the agency generally does not object to these corrective actions. This reflects a collaborative approach between regulatory authorities and industry stakeholders to uphold transparency and accuracy in marketing communications.
Reminder for Companies to Comply with Applicable Regulatory Requirements in Corrective Actions
Medical device companies must ensure that their corrective actions comply with all applicable regulatory requirements set forth by the FDA. This includes providing truthful and non-misleading information, adhering to labeling guidelines, and disclosing affiliations or relationships related to corrective information. Compliance with these requirements is essential to maintain ethical standards and regulatory compliance in marketing practices.
Recommendation for Companies to Maintain Records for Potential FDA Inquiries
As part of regulatory compliance, companies are advised to maintain detailed records of their marketing activities, corrective actions, and communications related to their medical devices. These records serve as evidence of compliance with FDA guidelines and can be valuable in addressing potential inquiries or audits by the FDA. Proper record-keeping demonstrates transparency, accountability, and a commitment to regulatory compliance within the medical device industry.
By adhering to these compliance and monitoring practices, medical device companies can uphold regulatory standards, address misinformation effectively, and maintain trust and credibility among consumers and regulatory authorities alike.
Navigating FDA Guidelines: Best Practices for Medical Device Advertising
Conclusion and Recommendations
Recap of Key Points from FDA’s Proposed Guidelines and Relevant Regulations
Throughout this discussion, we’ve explored the FDA’s proposed guidelines and regulations concerning medical device advertising on social media platforms. Key points include the importance of accurate and balanced communication of benefits and risks, addressing misinformation, and complying with FDA requirements for promotional
지난 2013년 6월 “Digital Health: Building Social Confidence in Pharma’라는 제목으로 웨버 샌드윅(Weber Shandwick)이 발표한 리포트는 현재 글로벌 제약회사에서 소셜 미디어 커뮤니케이션 활동을 책임지는 13명의 임원들과 마케팅 컨설턴트가 참여했으며, 제약회사들의 소셜 미디어 도입 현황, 도입 시 혜택, 극복과제, 실행 방안 등 주제별 주요 인사이트가 반영되어 있다.
Perficient Perspectives: The Evolution of Social Media in HealthcarePerficient, Inc.
Healthcare organizations continue to navigate the transforming healthcare industry and identify new avenues to engage with consumers outside of the facility walls. In a fast-paced, information-dominated world, successfully interacting with consumers may seem like a daunting task. The key is to connect with consumers where they are and provide them with actionable health and wellness information they need to live a healthier life.
When you think of social media in healthcare you might think it is a tool for marketing, but it goes much farther than that. Sure, social media can be used to attract and retain consumers, but social media can also be a powerful tool to reduce healthcare costs and help with chronic disease and population health management.
Healthcare organizations are in varying stages of becoming social enterprises, from social innovators like Mayo Clinic to those beginning the journey to developing a comprehensive social media strategy.
In this perspective, we take a look at the evolution of social media in healthcare and discuss what social media in healthcare will look like in the future.
In this special Ethics Month webinar, PRSA's Board of Ethics and Professional Standards (BEPS) provided insight and training for public relations professionals on social media ethics and how the PRSA Code of Ethics can help determine the proper course of action and protect you and your clients' reputation and credibility. Current examples of unethical practices in social media were examined. BEPS members also provided guidance on how public relations professionals can ensure their social-media campaigns uphold the ethical standards of the profession.
This transcript offers running commentary of a Sept. 27, 2011, #PRethics chat hosted by the Public Relations Society of America. The chat focused on whether public relations professionals should serve as the ethical conscience of their organizations or for their clients.
The Public Relations Society of America (PRSA) and the American Statistical Association (ASA) collaborated to develop a best practices guide for the use of statistics in public relations campaign. The guide serves as a primer for public relations professionals who must understand, interpret and communicate statistical issues. It also provides a contact lifeline for public relations professionals who need urgent statistical- or research-based help.
This transcript offers running commentary on the state of ethics in public relations. Hosted by PRSA and the CIPR, the Sept. 6, 2011, Tweet chat focused on the thoughts public relations professionals have about the current state of #PRethics.
This transcript offers running commentary on the state of ethics in public relations. Hosted by PRSA and the CIPR, the Sept. 6, 2011, Tweet chat focused on the thoughts public relations professionals have about the current state of #PRethics.
Overview of survey results from the PRSA 2011 membership satisfaction survey. Survey results show that 79% of current members report that they are likely to renew their membership.
PRSA Chair and CEO Rosanna M. Fiske, APR, delivered the keynote address at the 2011 Hispanicize Hispanic PR & Social Media Conference April 7, 2011, in Los Angeles. She addressed the rising value of public relations and marketing, particularly in the Hispanic-American market, in light of recent United States Census data showing more than 50 million Hispanic-Americans live in the U.S., with a combined annual buying power of more than $1 trillion.
The Public Relations Society of America (PRSA) offers legal, ethical and practical guidance for public relations professionals who record conversations and media interviews to ensure accuracy in reporting and transcription.
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www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
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Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
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At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
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Experience unparalleled EXTENDED STAY and comfort at Skye Residences located just minutes from Toronto Airport. Discover sophisticated accommodations tailored for discerning travelers.
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Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
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"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
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Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
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As a business owner in Delaware, staying on top of your tax obligations is paramount, especially with the annual deadline for Delaware Franchise Tax looming on March 1. One such obligation is the annual Delaware Franchise Tax, which serves as a crucial requirement for maintaining your company’s legal standing within the state. While the prospect of handling tax matters may seem daunting, rest assured that the process can be straightforward with the right guidance. In this comprehensive guide, we’ll walk you through the steps of filing your Delaware Franchise Tax and provide insights to help you navigate the process effectively.
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Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
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PRSA/WOMMA Comments — Advisements to FDA: Social Media Guidelines
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6. Response to Request for Comment
U.S. Food and Drug Administration
Comments Concerning Draft Guidance, Document No. 2011-33550
The Public Relations Society of America (“PRSA”) and the Word of Mouth Marketing Association
(“WOMMA”) are pleased to submit these comments and recommendations in response to the United
Stated Food and Drug Administration’s (“FDA”) invitation for comments regarding its Draft Guidance
for Industry Responding to Unsolicited Request for Off-Label Information About Prescription Drugs and
Medical Devices (the “Guidelines” or the “Guidance”).
PRSA (www.PRSA.org) is the leading global professional association of public relations and
communications professionals. PRSA represents 22,000 professional communicators in the public
relations and public affairs communities, and some 10,000 students in its affiliated organization, the
Public Relations Student Society of America. PRSA is responsible for representing, educating, setting
standards of excellence and best practices, providing certification and upholding principles of ethics for
its members, and more broadly, the $5.7 billion U.S. public relations industry.
Members of PRSA include: independent practitioners; small business owners; employees of government
agencies; corporations; academic institutions; law firms and professional services practices; public
relations firms of all sizes and practice specialties; and nonprofit institutions of every size and description.
PRSA membership also includes professionals who engage in public relations as part of a comprehensive
mix of marketing communications and advertising strategies to achieve client objectives. Members of
PRSA abide by a mandatory Code of Ethics that establishes core values, principles and practice
guidelines that define their professionalism and advance their success.
WOMMA (www.WOMMA.org) is the leading trade association in the marketing and advertising
industries that focuses on word-of-mouth, consumer-generated and social media platforms — marketing
techniques that include buzz, viral, community and influencer marketing as well as brand blogging and
enhancement. Founded in 2005, WOMMA has approximately 450 members, which include: (i) marketers
and brands that use word of mouth marketing to reinforce their core customers and to reach out to new
consumers; (ii) agencies that deliver word-of-mouth services and technologies; (iii) researchers that track
the word-of-mouth experience; and (iv) offline and online practitioners.
Members of WOMMA abide by mandatory Standards of Conduct and a Code of Ethics that establishes
“best practices” guidelines designed to assist in the development of compliance procedures to evaluate
and execute marketing campaigns. This Code, in fact, was favorably recognized by the Federal Trade
Commission in the agency’s recent release of its Guides Concerning the Use of Endorsements and
Testimonials in Advertising.
Focus of PRSA / WOMMA Comments
We are providing these comments to ensure the continued strength of open and honest communications
that help foster informed decision-making in America.
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
FDA Document No. 2011-33550 Page 1
7. Furthermore, given PRSA’s mission to advance the public relations profession and professional, and
WOMMA’s commitment to developing and maintaining appropriate ethical standards for marketers,
advertisers, and brands engaging in such marketing practices, identifying meaningful measurement
standards for such marketing practices, and defining “best practices” for the industry, our mutual interest
is in ensuring the more than 200,000 professional communicators in the United States, many of whom
work in the health care or pharmaceutical industries, are provided with proper guidance concerning how
to appropriately — and legally — market to and communicate with consumers online.
We appreciate the degree of consideration the FDA has given in developing its proposed Guidelines.
After more than five years of requests by businesses and marketers for proper guidance concerning
brands’ online interactions with consumers, the Guidelines provide a workable platform upon which to
develop more robust guidance and industry standards.
While a start, the Guidelines do not go far enough in properly guiding pharmaceutical and health care
communicators and marketers as to the legal and appropriate means by which they can communicate with
and market to consumers in response to requests for off-label information about prescription drugs and
medical devices.
The proposed Guidelines fail to address the dynamic impact that social media and digital communications
have had on American consumers and on society’s decision-making processes. As more consumers seek
opportunities to engage with businesses and discover valuable patient and health-care information online,
it is vital that the FDA provide businesses, communicators and marketers with proper guidance on how
they can deliver this information, via social media, in an appropriate manner.
Given that eight in 10 Internet users are looking online for health information, according to the Pew
Internet & American Life Project1, there is an urgent need for the FDA to provide the health care and
pharmaceutical industries with proper guidance on how, when and where they can use social media and
other direct-to-consumer communications and marketing platforms to engage with and respond to
consumers.
It is not only marketers and communicators that are actively seeking opportunities to distribute health care
and wellness information via social media communications in the pharmaceutical and health care
industries; it is consumers themselves, who want access to information and representatives from
companies that can quickly and efficiently answer their questions. According to a 2012 report by
Manhattan Research2, “42 percent of online adults agree that pharmaceutical companies should be
involved in online health communities for consumers.” That same report also found that consumer use of
social media for health is on the rise — growing from 63 million U.S. adults accessing health-related
user-generated content in 2008 to 107 million in 2011.
A continuing lack of detailed guidance for use of social media tools and platforms will prolong the issues
pharmaceutical and health care communicators and marketers face in effectively educating and
communicating with consumers about valuable information they need to improve their lives. It will also
deprive consumers of necessary information they need to make informed decisions regarding their health.
1
Pew Internet & American Life Project, “Pew Internet: Health — Highlights of the Pew Internet Project’s Research Related to
Health and Health Care.” It is published at: http://www.pewinternet.org/Commentary/2011/November/Pew-Internet-Health.aspx
2
Manhattan Research “ePharma Consumer(R) study.” It is published at: http://www.marketwatch.com/story/42-percent-of-
online-consumers-think-pharma-companies-should-be-involved-in-online-health-communities-addadhd-and-bipolar-disorder-
caregivers-top-groups-to-agree-2012-01-17.
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FDA Document No. 2011-33550 Page 2
8. This, we believe, is hindering the development of innovative and needed communications between
businesses and consumers.
Guidelines Need to Provide Specific Recommendations
The American public and health care marketers are equally deserving of the opportunity to communicate
with one another online in a manner that protects their respective interests. The FDA’s work is critical to
overcoming key obstacles in this regard.
We also appreciate that the FDA has an obligation to protect consumer welfare and serve as an advocate
for consumers; those interests include the public’s online interactions and communications with
businesses and their representatives.
If consumers can’t find the information they want and/or need online from businesses then they are going
to go elsewhere to find such information indirectly. It is the responsibility of the FDA to protect
consumers and develop a regulatory framework within the marketplace that both supports innovation and
provides for proper constraints that protect the public’s best interests and allows for the most direct and
accurate exchange of information.
The proposed Guidelines do not meet these requirements as they continue to ignore the public’s desire to
access information in an expedient and efficient manner online and via social media.
PRSA and WOMMA appreciate the complexity of the FDA’s assignment; however, the Guidelines that
have been presented are not of the level necessary to properly protect consumer interests and ensure
health care and pharmaceutical companies can retain an effective and robust presence in the emerging-
media landscape. This will only lead to a gap in open and transparent communication. Furthermore, the
prolonged delay in developing proper social-media guidelines is a detriment to the online patient
communities who rely on these communications for information and support.
Our members in the public relations, word-of-mouth and digital marketing industries are committed to
responsible, ethical and transparent communications in the social media space, and they need the FDA’s
guidance on how to do so properly and appropriately. We believe that by providing communicators and
marketers in the health care and pharmaceutical industries with proper and timely social-media guidance,
the FDA will help enhance the quality of information available to consumers, while ensuring businesses
can continue to innovate, both in their online marketing communications strategies and product
development.
Our members need the FDA’s guidance on how to do so properly and appropriately.
Concerns with the Guidance
We understand and appreciate the FDA’s stated concerns that any specific guidance relevant to
technologies or social networks may preclude the Guidelines from being useful in the years to come as
technology and platforms change. However, more than five years into the age of social media, the time
has come for the FDA to properly guide those industries that it regulates — in this case, pharmaceutical
and health care companies and organizations — about ways in which they can specifically use certain
social networks to communicate with and market consumers.
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9. Because of a lack of proper guidance from government regulators, the pharmaceutical sector, in our
estimation, is at least four years behind the consumer side of social media marketing and
communications. This has led to numerous issues that continue to persist, both for marketers and
consumers.
For example, Why can’t people find timely and relevant information about specific pharmaceutical
products or medical devices in social networks? Consumers are spending increasing amounts of time
online, particularly on social networks, or are augmenting their real-world physical shopping experiences
with digital devices that help them make more informed decisions. Nine out of 10 U.S. consumers visited
a social network at least once a month last year, according to Web measurement firm comScore Inc.3
Social media is fast becoming a top choice among consumers for finding health care information. A 2011
survey conducted by the National Research Corporation found that of 23,000 Americans surveyed, 16
percent said they use social media to learn more about health issues4. One in four respondents5 said what
they learned on these sites was “very likely” or “likely” to impact their future health decisions, with 32
percent saying they have a “very high” or “high” level of trust in the information about health care they
obtain via social media.
We believe these physical-digital search and shopping experiences can and should be enhanced by
responsible and ethical communications between pharmaceutical and health care companies and
consumers.
Suggestions Relating to Overall Guidance
This emerging reality should be met by a robust set of Guidelines from the FDA. That guidance might
cover:
• Platform-specific issues.
• Disclosure.
• Conflicts-of-interest.
• Direct versus indirect communications.
We further suggest that the FDA provide for some form of responsible, self-regulated infrastructure in
which companies can proactively and reactively communicate with consumers online, via social media
and other digital forums, in a manner that answers their questions, provides information and aids in
society’s informed decision making.
As it stands now, much of the burden is placed on consumers to access information from companies. This
does not reflect the realities of the digital age, in which people have access to almost unlimited amounts
of information and data. Organizations need to be providing consumers with accurate, unbiased
information direct from the source. Instead, consumers are forced to find “work-arounds” to access
3
“Nearly 15% of the Time Consumers Spend Online Is on Facebook,” Internet Retailer, Feb. 13, 2012. It is published at:
http://www.internetretailer.com/2012/02/13/nearly-15-time-consumers-spend-online-facebook.
4
“Patients Use Facebook, Twitter to Get Health Information,” CNN.com, March 4, 2011. It is published at:
http://thechart.blogs.cnn.com/2011/03/04/patients-use-facebook-twitter-to-get-health-information/.
5
“1 in 5 Americans Use Social Media for Health Care Information,” Feb. 28, 2011. National Research Corporation. It is
published at: http://hcmg.nationalresearch.com/public/News.aspx?ID=9.
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10. information online, thus subjecting them to potentially spurious or unethical marketing practices or the
transmission of incorrect information.
While we appreciate the challenge of providing comprehensive guidelines to the industry where
technology is changing on a daily basis, we believe that the FDA could issue core principles and
regulatory standards that could guide the industry toward regulatory responsibility while not chilling their
ability to communicate with consumers who desire to know essential information. Specifically, we would
recommend that the FDA provide the industry with the following four core fundamental principles that
govern operating procedures:
Principle No. 1: Companies have a fundamental interest in participating in social media platforms
concerning the medicines or products they provide, and the conditions these medicines and products
address.
Principle No. 2: Governmental regulation concerning such participation must only relate to those
communications that constitute commercial promotional activities sponsored by the companies.
Principle No. 3: Any governmental regulation concerning such commercial promotional activity must be
narrowly and appropriately tailored to ensure that those communications are (i) truthful; (ii) balanced and
not deceptive; and (iii) transparent.
Principle No. 4: Any such governmental regulation must account for the nature and navigational realities
of various social media platforms, such as the ability to use links and space constraints in certain
environments or platforms.
In addition, we would recommend that the FDA provide the industry with the following regulatory
standards for communications that advocate or promote a particular product for a consumer to purchase:
Standard 1: Companies are responsible only for those activities that (a) constitute promotional
communications directed to consumers and (b) are intentionally sponsored by the company. In other
words, FDA regulatory guidelines concerning advertising by pharma and other health care companies are
to apply only to those communications that (i) are sponsored and (ii) constitute promotional messages
designed to influence consumer purchasing decisions.
Example: Non-branded disease awareness communications do not constitute promotional
communications.
Standard 2: Companies are only responsible for content provided in social media communications that is
under the company’s control, ownership, or operation; or for that content they specifically provide to
third-parties, such as WebMD.
Standard 3: Companies are responsible for monitoring only those platforms or communications that are
under their “sphere of influence.” In other words, companies are responsible for monitoring the discussion
only when they have been actively engaged in the promotional messaging within that community.
Example: Companies should be responsible for monitoring discussion in a community that they
have created or posted content. If a brand representative goes into WebMD discussion boards and
posts information, the brand should monitor the follow-up discussions for questions,
misinformation, adverse event reporting and the like.
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11. Standard 4: Companies are responsible for reporting adverse events only in those circumstances arising
from their monitoring activities (as described in Standard No. 3 above). Yet, in monitoring and evaluating
such adverse event incidents, the privacy interests of consumers must be respected.
Standard 5: Any content for which companies are responsible must be transparent, disclosing all
material connections between the company and the speaker.
Note: The Guides for the Use of Testimonials and Endorsements in Advertising recently provided by the
Federal Trade Commission provide an appropriate framework.
Standard 6: For content that requires disclosures that are needed to prevent deceptive or misleading
information, companies are responsible to ensure that such disclosures be made clearly and conspicuously
given the practical constraints of the particular platform used.
Note: The “clear and conspicuous” standard by the Federal Trade Commission provides an appropriate
and flexible approach.
We believe these principles and standards would be a prudent and proactive move forward by the FDA.
* * *
PRSA and WOMMA appreciate the opportunity to submit these comments and look forward to
continuing to work with the FDA to promote innovation and protect consumers. Please contact Keith
Trivitt at (212) 460-1495 or keith.trivitt@prsa.org, or Anthony DiResta at (202) 282-5782 or
adiresta@winston.com with questions.
Respectfully submitted,
Gerard F. Corbett, APR, Fellow PRSA
Chair and Chief Executive Officer
Public Relations Society of America
gerard.corbett@prsa.org
(212) 460-1400
Anthony E. DiResta
General Counsel, WOMMA
WINSTON &STRAWN LLP
1700 K Street, N.W.
Washington, D.C. 20006
adiresta@winston.com
(202) 282-5782
Comments of Public Relations Society of America and Word of Mouth Marketing Association to
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