April 29, 2013 – Although the Digital Advertising Alliance (DAA) has made great strides to protect consumers’ privacy online – which include its industry Self-regulatory Program for Online Behavioral Advertising and its “Your Ad Choices” public education campaign – the Senate Commerce Committee appears to be underwhelmed by companies’ self-regulation efforts and the DAA’s promise to honor “Do Not Track” requests from consumers.
“Consumers are still waiting for these Do Not Track standards. Advertisers are continuing to ignore Do Not Track headers and consumers’ requests for privacy,” said Sen. Jay Rockefeller (D-W. Va.), Chairman of the Senate Commerce Committee, at an April 24 hearing: “A Status Update on the Development of Voluntary Do-Not-Track Standards.”
“I have long expressed skepticism about the ability – or willingness – of companies to regulate themselves on behalf of consumers when it affects their bottom line,” Rockefeller said. “I disclose a generally troubling feeling I have about the nature of corporations around the chance to make money when people don’t know” what information is being collected about them, he continued.
DAA Self-regulatory Program Status
The DAA’s program is designed to provide choice to consumers regarding how they want their privacy protected. “The DAA’s efforts have helped to ensure that consumers will continue to have preferences regarding which ads they wish to see using a one-button mechanism,” said Coalition for Healthcare Communication Executive Director John Kamp. “But clearly, there is still more work to be done and stakeholders have to find common ground to move forward successfully.”
In February 2012, the DAA announced that it would begin work to recognize browser-based choices with a set of tools by which consumers could express their preferences under the DAA principles. Since then, two browser companies, Microsoft and Mozilla, have announced plans to install Do Not Track features that would automatically default to full protection without consumers having to make a choice.
DAA Managing Director Lou Mastria testified before the Senate committee that these features undermine the industry agreement made in February 2012, because they remove consumer choice – a linchpin in the agreement – from the equation.
In March 2012, the Federal Trade Commission (FTC) called on industry to step up self-regulatory practices or live with Congress stepping in. At the recent American Advertising Federation annual advertising day on Capitol Hill, FTC Chairwoman Edith Ramirez stated that the advertising industry should work with the World Wide Web Consortium (W3C) to develop a browser-based solution and praised Microsoft and Mozilla for their efforts, so it appears that support for voluntary programs may be wavering.
Although Harvey Anderson, Mozilla Senior Vice President of Business and Legal Affairs, told the committee that “industry has not moved forward quickly enough,” and that “the efficacy of the Ad Choice program remains questionable,” he did also state that “the work of the DAA should be acknowledged.”
Mastria told the committee that the DAA self-regulatory program protects consumers while also allowing them access to ad-supported content, adding that changes to the current paradigm would harm small publishers while also “chilling innovation.” He said that the DAA “is a solution provider” and the only entity that actually delivers choice for consumers.
“Today, the DAA calls on all stakeholders, including the FTC, W3C, Microsoft and Mozilla to honor the terms of the [February 2012] announcement and remove impediments that are preventing implementation of browser-driven choice for consumers,” Mastria said.
Is Legislation Needed?
Sen. Richard Blumenthal (D-Conn.) asked whether Congress should move forward with legislation in this area, because “when voluntary agreements fail to provide compliance, that’s the classic instance where a law is needed.” Mastria replied that “legislative or technological fiats are not necessarily what the Internet needs. A nimble, self-regulatory approach [like DAA’s] is exactly the kind of thing that fosters consumer trust while protecting privacy.”
He later added that the DAA program delivers “the very mechanisms” that are in Do Not Track legislation (DNT2013) introduced Feb. 28 by Rockefeller and Blumenthal. This legislation would:
- Create a universal legal obligation for all online companies to honor consumer choice when consumers do not want anyone to collect information about their online activities;
- Allow the FTC to pursue enforcement action against any company that does not honor this request by consumers;
- Allow companies, upon consumer requests to not be tracked, to collect only the information that is necessary for the Web site or online service to function and be effective, but then place a legal obligation on the online company to destroy or make anonymous the information after it is no longer needed.
“Industry needs to strongly advocate for – and deliver on – its promise to implement the levels of online privacy protection that the public is seeking,” Kamp said. “For the DAA’s program to thrive, consensus on how the program will work for all stakeholders is key.”
April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye on FDA/Fleishman-Hillard, is based on analysis of a database of FDA/Office of Prescription Drug Promotion (OPDP) enforcement letters, and takes a close look at how, in the absence of FDA guidance on digital communications and social media, the agency enforces alleged violations in these media.
“Lacking any sort of formal guidance from the agency, the only peek into FDA’s point of view is to examine enforcement patterns,” according to Mark Senak, Eye on FDA author and Senior Vice President & Partner, Fleishman-Hillard. For the period of 2008-2012, Senak set out to determine how violations by digital communications properties compared to violations by traditional (non-digital) communications vehicles.
“Given the lack of guidance by the FDA, an examination of regulatory action letters over the period of time during which social media became prominent could provide oversight into (1) whether digital communications led to a change in regulatory actions and (2) potential agency points of view derived from action letters involving social media,” the White Paper states.
Of the 173 letters sent by OPDP during this time period, 26 percent involved the issuance of a Warning Letter and 74 percent were Notices of Violation. Of the 45 Warning Letters issued, only 12 cited digital communications vehicles, the report states, and only a single enforcement letter has been issued regarding a social media platform. In that letter, it was the nature of the social media mechanism that brought about the violation, the author notes.
“As more and more people utilize digital and social media to get healthcare information, getting information about the regulatory parameters in which industry can operate is extremely important,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “There are still more questions than answers, but this paper sheds some important light onto the patterns of enforcement of digital over non-digital communications.”
For full results and analysis, go to: http://www.eyeonfda.com/eye_on_fda/2013/04/some-digital-and-social-media-guidance-fda-regulation-of-pharma-communications-in-a-digital-era-a-white-paper.html
March 19, 2013 – Although the FDA has not yet issued its long-awaited social media guidance for the biopharma industry, whatever guidelines it drafts on this topic are likely to be informed by the staff guidance document issued last week by the Federal Trade Commission (FTC). The FTC’s new guidance, “.com Disclosures,” revises an FTC document issued in 2000 and, essentially, advises advertisers that online ad claims must be “clear and conspicuous” and that it is the message, not the medium that defines compliant ads. According to the guidance, “cyberspace is not without boundaries, and deception is unlawful no matter what the medium.”
“The FTC has led the way on these issues and continues to do so. Clearly, the FDA will recognize the leadership here and likely move forward similarly. I’m optimistic that we will see similar guidance soon from FDA’s Office of Prescription Drug Promotion,” noted John Kamp, Executive Director, Coalition for Healthcare Communication.
The updated FTC guidance emphasizes that consumer protection laws apply equally to marketers across all media, “whether delivered on a desktop computer, a mobile device, or more traditional media such as television, radio, or print,” according to an FTC press release. The FTC stated that if disclosures are needed to prevent an online ad claim from being deceptive or unfair, they must ensure that these disclosures are clear and conspicuous “on all devices and platforms that consumers may use to view the ad.”
As an article in The Wall Street Journal noted, “That means making room for full disclosure even in a 140-character tweet on Twitter. The agency suggested that marketers could flag Twitter ads by including ‘Ad:’ (three characters) at the beginning of the post or the word ‘sponsored’ (nine characters).”[1] The FTC also clarified in the new guidance that disclosures should be “as close as possible” to the relevant claim,” which is a revision from the 2000 guidance, which called for disclosures to be “near, and when possible, on the same screen.”
Indeed, when practical, the FTC would like advertisers to incorporate relevant limitations and qualifying information into the underlying claim, rather than have a separate disclosure qualifying the claim. Where that is not possible, the agency continued to caution advertisers that they should avoid using hyperlinks
for disclosures and that “required disclosures about serious health and safety issues are unlikely to be effective when accessible only through a hyperlink.”
The FTC’s hyperlink restrictions could very likely be adopted by the FDA. Industry attorney Arnie Friede, a former FDA associate chief counsel, told Pharmalot.com that “the FDA can certainly hang its hat on this language to say that even the FTC rejects disclosures via hyperlink of important health and safety information, e.g., ‘fair balance’ information.”[2]
The FTC also asks marketers to avoid “conveying such disclosures through pop-ups, because they are often blocked” and states that if a disclosure is necessary to prevent an advertisement from being deceptive, unfair or otherwise violative of a Commission rule, and it is not possible to make the disclosure clearly and conspicuously, “then that ad should not be disseminated. This means that if a particular platform does not provide an opportunity to make clear and conspicuous disclosures, then that platform should not be used to disseminate advertisements that require disclosures.”
In the final analysis, the FTC concludes, “the ultimate test is whether the information intended to be disclosed is actually conveyed to consumers.”
[1] Yadron, Danny and Ovide, Shira; “FTC Says Tweet Ads Need Some Fine Print,”
The Wall Street Journal (March 12, 2013)
[2] Silverman, Ed; “Will FDA Emulate FTC Online Ad Guidance?” Pharmalot.com (March 13, 2013).
Aug. 22, 2012 — Sanofi is moving forward with social media efforts for diabetes using its own social media rules in the absence of guidance on the topic from the FDA, according to a Beyond the Pill article discussing a post on Fast Company.
It appears that Sanofi and other companies pursuing social media marketing may have time to experiment with different approaches, as the publication of the document is not imminent. “We are working on the area and
it’s something we feel is important but we don’t
have a specific timeline right now,” Ernest Voyard, senior regulatory council at the FDA’s Office of Prescription Drug Promotion, told Fast Company.
To read the full article, go to: http://beyondthepill.medivo.com/2012/08/sanofi-writing-the-rules-of-social-media/
July 12,
2012 – In a July
12 entry on his DrugWonks.com blog, Center for Medicine in the Public Interest Co-founder and President Peter Pitts discusses how Eli Lilly & Co. is using social media to its advantage. This example is significant, because many pharmaceutical companies continue to struggle with how – and how much – to involve social media in their promotional strategies.
Read more at: http://drugwonks.com/blog/a-little-guilding-of-the-eli-lilly
June 12, 2012 – Advertisers should not unintentionally provide financial support to “rogue” Internet sites that are dedicated to the infringement of the intellectual property of others and need to have confidence that their corporate brands and images are not being compromised by association with such unlawful activity, according to a statement of best practices issued recently by the Association of National Advertisers (ANA) and the
American Association of Advertising Agencies (4A’s) (see http://www.aaaa.org/news/bulletins/Pages/mmpirate_053112.aspx).
“The deceptive practices of these rogue Web sites are unfair both to consumers and the companies that invest vast resources to establish brand integrity,” said 4A’s President-CEO Nancy Hill. “Combatting online piracy and counterfeiting is a key priority for the entire business community.”
The 4A’s moved forward with the statement of best practices to raise awareness that its member companies “may have unwittingly supported pirated or rogue sites when using ad networks,” according to GroupM Interaction Chief Operating Officer John Montgomery, who also serves as chairman of the 4A’s Privacy Committee.
GroupM – which buys nearly one-third of the world’s media, Montgomery said – blocks advertising at rogue sites by using verification agencies to identify illegal sites and attaching a list of those sites to insertion orders which specify that ads not be placed on those sites. “We want to cut off rogue sites’ funding,” he said.
The 4A’s/ANA statement of best practices takes a similar approach. The groups encourage their members to address rogue sites that are dedicated to intellectual property infringement by including specific language in media placement contracts and insertion orders with ad networks and other intermediaries involved with their U.S.-originated digital advertising campaigns on both domestic and foreign Internet sites.
The document sets forth the groups’ belief “that our members should each commit to take affirmative steps to avoid placement of ads on such sites. This commitment is not intended to foreclose advertising on legitimate social media or user-generated content sites, even if infringing content occasionally appears on such sites.”
The language the groups suggest that its members adopt includes:
- All such intermediaries shall use commercially reasonable measures to prevent ads from being placed on such sites.
- All such intermediaries shall have and implement commercially reasonable processes for removing or excluding such sites from their services, and for expeditiously terminating non-compliant ad placements, in response to reasonable and sufficiently detailed complaints or notices from rights holders and advertisers.
- All such intermediaries shall refund or credit the advertiser for the fees, costs and/or value associated with non-compliant ad placements, or provide alternative remediation.
Even if advertisers include these provisions (or adapt them in a manner appropriate to their businesses) the ANA and the 4A’s acknowledge that “in the context of a highly dynamic and complex digital advertising ecosystem” that “inadvertent con-compliant ad placements will occasionally occur.”
Still, the statement reads, “we should not knowingly allow our businesses and brands to supply financial life-blood or lend a veneer of legitimacy to fundamentally illicit business models.”
“Piracy is a widespread problem,” Montgomery said. “We want to encourage our industry to take a look at this issue and consider taking action.”
By John Kamp, Executive Director, Coalition for Healthcare Communication
May 18, 2012 — Sen. Claire McCaskill (D-Mo.) told a group of senior advertising executives this morning at the AAAA’s New York offices that elimination of the deduction for marketing expenses remains possible, especially during the “lame duck” session of Congress following the November election.
“I wish I could tell you that you don’t need to worry, but the Congress needs to identify $4-5 trillion in combined spending cuts and new revenues,” McCaskill said. “With the deduction for popular items such as the home mortgage deduction on the list, you can bet relatively obscure items with be there, too,” she remarked.
McCaskill reminded the heads of the ANA, the AAAA, the Internet Advertising Bureau, the Coalition for Healthcare Communication and others that after the failure of the SuperCommittee to come up with the needed cuts, several “automatic triggers” will take effect on Jan. 1, 2013, that reduce funding for defense, Medicare, and other programs, as well as eliminate the Bush tax cuts.
The senator opened her discussion focusing on the multiple privacy proposals she said would “blow a hole in the profitability of Internet advertising business in this country.” She further opined that “neither the White House, the FTC, nor many senators understand how dangerous these proposals are and could easily vote for them.” She also noted that several private companies, including
Mozilla Firefox, are working on browsers that effectively “visualize” data gathering on a browser and how to avoid it.
For more information on this session, please contact John Kamp at: jkamp@wileyrein.com
March 8, 2012 – Fifteen trade associations – including the Coalition for Healthcare Communication – sent a letter to Congressional leaders this week asking them to hold off on pursuing consumer privacy legislation while industry-led self-regulatory program efforts take hold.
Because these efforts are an efficient and effective way to protect consumer privacy interests, the groups are concerned that new legislation “could undermine future efforts for successful voluntary practices,” according to the Industry Letter to Leadership re Privacy Legislation, which was delivered to all members of the House Energy & Commerce Committee and the Senate Commerce and Judiciary Committees.
“Contrary to many press reports, the industry opposes legislation at this time. Instead, Congress should acknowledge that industry self-regulation is working and give the process time to take root,” said Coalition for Healthcare Communication Executive Director John Kamp. “Even though industry needs to do more to fully engage Web stakeholders, early efforts are very promising. Voluntary, collaborative self-regulation is far superior to government regulation.”
The trade association letter stresses that voluntary codes of conduct, unlike government regulation or legislation, “can adapt in a timely manner to shifting technologies, business models, and consumer expectations.”
Indeed, in February, the Digital Advertising Alliance (DAA) and its members were praised by White House, Department of Commerce and Federal Trade Commission officials for their efforts, which include the DAA’s Self-regulatory Program for Online Behavioral Advertising and
“Your Ad Choices” public education advertising campaign.
Voluntary programs, the industry groups contend, also can address privacy concerns “without interfering with innovation, which benefits consumers by delivering paychecks, savings, and exciting products and services.” These programs, they conclude, are “the ideal way to balance privacy and innovation.”
Meanwhile, Kamp implores industry members “to get on board with voluntary programs today to help prove industry’s commitment to consumer privacy, because legislation will come in the absence of robust industry participation.”
In addition to the Coalition, associations signing the letter include: American Advertising Federation, American Association of Advertising Agencies, American Business Media, Association of National Advertisers, Consumer Electronics Association, Direct Marketing Association, Financial Services Roundtable, Interactive Advertising Bureau, National Retail Federation, NetChoice, Online Publishers Association, Performance Marketing Association, Toy Industry Association, and U.S. Chamber of Commerce.
Feb. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer Privacy Bill of Rights,” the Digital Advertising Alliance (DAA) and its members were praised by White House, Department of Commerce and Federal Trade Commission officials for their efforts during the past three years to protect consumers’ privacy online. These efforts include the DAA’s Self-regulatory Program for Online Behavioral Advertising and last month’s “Your Ad Choices” public education advertising campaign.
“While privacy remains one of the most challenging issues in the Internet age, the Coalition for Healthcare Communication, through its work with the American Association of Advertising Agencies, is proud to be part of the solution announced by the White House today to enable consumers to better exercise their privacy and marketing preferences,” said Coalition Executive Director John Kamp. “Much still remains to be done, including urging all Web publishers, agencies and clients to take full advantage of the DAA’s self-regulatory program
in order to create a more robust and trustworthy Internet marketplace,” he added.
The DAA also announced today that it will immediately begin work to recognize browser-based choices with a set of tools by which consumers can express their preferences under the DAA principles.
“The Administration, Congress, and the FTC have been pushing the business community for several years to make sure consumers are aware of the information practices occuring online and providing choices to consumers regarding the collection and use of information about them,” said DAA General Counsel Stu Ingis. “The DAA is an embodiment of leading companies responding to this call.”
For more information on this groundbreaking news, see the press release from the 4A’s, released at noon today: http://www.aaaa.org/news/press/Pages/022312_daa_whitehouse.aspx
Feb. 7, 2012 – Responding to patient and professional calls for more industry participation in the Internet and social media, a broad-based industry group – including the Coalition for Healthcare Communication – yesterday issued “guiding principles” at a members meeting in New York City to advance the digital presence of the medicines industry.
The Digital Health Coalition (DHC), co-chaired by Joe Farris and Mark Bard, introduced seven “Guiding Principles and Best Practices for Companies and Users” which represent a consensus of nearly 60 members, including drug and device companies, advertising and other marketing agencies, patient groups and others.
“Industry is leading the way with these principles and we hope FDA soon will follow with more definitive regulatory guidance,” said Coalition Executive Director John Kamp, who is a 2011 Digital Health Scholar. “But patients and healthcare professionals expect robust participation in these media today. Hats off to Joe and Mark for organizing the effort and providing the spark to move us all forward.”
At the same meeting, Bard announced plans to create a task force of DHC leaders to create rigorous guidelines on when companies have control of digital content and thus can be held responsible for it by the FDA and other regulators. “Until the parameters of control and responsibility are more clearly developed, we cannot expect all companies to fully participate in the digital environment,” explained Kamp. “This is the next critical step for the DHC and all stakeholders in digital medicine.”
The seven principles announced yesterday are as follows:
- Regulated healthcare companies should endeavor to participate in social media as a means to promote public health, improve patient outcomes and facilitate productive patient/physician relationships.
- Regulated healthcare companies are not responsible for user-generated content online that they do not control. Regulated healthcare companies are deemed to “control” health and medical content if (i) it owns such health and medical content and has material editorial authority or (ii) it paid for the creation of such content and has material editorial authority over such content.
- Regulated healthcare companies have a responsibility to report adverse events they become aware of. Regulated healthcare companies should follow the existing adverse event reporting rules in place at the FDA.
- Employees of regulated healthcare companies should disclose their material company relationship when posting comments/content or engaging in an online conversation relating to a company product or relevant healthcare issue.
- Regulated healthcare companies should endeavor to respond to questions on sites they control within a reasonable period of time, and to implement reasonable measures to enable timely responses to crisis and emergency situations.
- Regulated healthcare companies should endeavor to make reasonable efforts to correct misinformation that is factually incorrect.
- Regulated healthcare companies should endeavor to appoint employee(s) tasked with the role of “patient liaison” focused on representing the best interests of the patient online.
The DHC is a nonprofit organization with 501(c)(3) status and was created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services.
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