By John Kamp, Executive Director, Coalition for Healthcare Communication
June 29, 2011 — Yesterday I had the pleasure of moderating a lively panel discussion at the 2011 BIO annual meeting in D.C., titled: “Talking About Your Product in the New Age: Social Media and the Internet.” While every speaker recognized the regulatory uncertainty and complexity of Internet marketing, all also agreed that industry must engage patients, caregivers and providers on the Internet or risk becoming irrelevant in many of the most important health conversations.
As regulators at FDA, FTC and Congress contemplate additional rules, consumers and healthcare professionals are consuming information on the Internet with increasing speed. Our industry knows the most about the safe and effective use of its products. Although we must follow existing rules and be prepared for new ones, we also need to offer our first-line expertise wherever our customers seek it. If industry leads responsibly, government will follow.
We have a long way to go. Yesterday, Coalition board member Michael Myers, President of Palio (InVentiv), most effectively drove home the message in his closing presentation. Using just three examples – Facebook, YouTube and Twitter – he presented data showing that pharma is way behind other brands on social media outreach. His most effective tool was a YouTube video by Erik Qualman, author of socialnomics: how social media transforms the way we live and do business (http://www.youtube.com/watch?v=x0EnhXn5boM). This four-minute video “says it all,” according to Myers.
To tease you into downloading it, here are just a few tidbits:
- Social media is “word of mouth … on steroids”
- 90 percent of consumers trust peer recommendations
- Just 14 percent of consumers trust ads
- 93 percent of marketers use social media for business
For Facebook, YouTube and Twitter, Myers showed the amazing growth in consumer and marketing use, including examples of outstanding pharma sites. While we all know Facebook use is extensive, Myers stated that consumers spend more than 700 billion minutes per month on Facebook. And, although many pharma brands have pages – even as Facebook is limiting control – the average pharmaceutical Facebook page analyzed had roughly 13,000 fans compared to the millions of Starbucks fans, noted Myers.
Meanwhile, YouTube serves as a medium to push and share a large amount of content, Myers said, and is second to Google as a search engine. It has the highest number of page views on any social media site; the average YouTube user is between the ages of 18 and 54 and 70 percent of traffic comes from outside of the United States. Pharma YouTube accounts have relatively few subscribers and channel views, he noted. Also, the average pharmaceutical Twitter page that Myers analyzed had roughly 1,800 followers.
Summarizing, Myers says better use of social media will be integral to a company’s future success, adding that the return on investment of social media “is your business will still exist in five years.”
Notwithstanding these facts, many in industry have been waiting for the FDA’s impending draft guidance on social media before moving forward aggressively. According to DDMAC head Tom Abrams at the DIA annual meeting two weeks ago, FDA at last may be close to issuing the first of those guidances. But we’ve heard that before, and remember, Abrams also has stated repeatedly that these guidances will not make any new FDA policy, just “clarify” existing policy for the new media.
Study after study confirms that consumers are not waiting for the FDA and the FTC to establish their Internet rules before seeking health information online. For example, a recent Pew Internet Project/California HealthCare Foundation survey found that 66 percent of consumers look online for information about a specific disease or medical problem. And, doctors and other health providers are ahead of consumers in terms of their Internet use.
Meanwhile, a study supported by PhRMA found that a majority of physicians believe that industry’s detail forces provide valuable patient information. Industry needs to be on the Internet, on iPads and Blackberrys, and on desktop screens, regardless of institutional, social and regulatory barriers.
At present the industry is using various strategies to cope with existing barriers. Many companies only host social media sites about relevant disease states – avoiding branded drug sites to steer clear of off-label and adverse event issues. Where companies host branded sites, the company’s insistence that only on-label uses be discussed can confuse and sometimes anger site visitors who do not understand the FDA constraints.
Another challenge for companies is providing FDA-required safety information in space-restricted media. One solution not yet addressed by the FDA is an industry proposal to allow the use of a universal symbol for sites that feature FDA-regulated benefit and risk information. This proposal would point users to reliable information vetted by the FDA, helping patients to cull the good from the bad among information providers.
Companies also must heed the FTC’s privacy policies and its increasing warnings about social media and digital marketing. The FTC is actively enforcing social media infractions and may receive additional authority to regulate online behavioral advertising – including the possibility of establishing a mandatory “Do Not Track” mechanism – if pending bills in the House and Senate become law.
The Coalition and others oppose mandatory Do Not Track provisions and believe that consumer privacy and robust Internet commerce is better served by self-regulation. The new Digital Advertising Alliance has created the icon shown here to enable easy consumer opt-outs of unwanted tracking and marketing. For more information visit: www.AboutAds.info
Pitts: BIO’s Call for Drastic Regulatory Change Is On Point
June 27, 2011 — In a recent blog entry on DrugWonks.com, Peter Pitts commended BIO’s proposals to revamp the U.S. regulatory system for new treatments and therapies. Pitts mentions that BIO’s plans, as reported in BioCentury, include a progressive approval pathway for unmet condition therapies, a fixed term for the Commissioner of Food and Drugs, a redefinition of FDA’s mission and the FDA as an independent agency, separate from the Department of Health & Human Services.
Read more on the DrugWonks.com Web site
June 27, 2011 — The Food and Drug Administration (FDA) should move forward with its social media/Internet guidance and not wait for the results of the three studies it recently announced it would conduct to test benefit and risk information presentations on direct-to-consumer (DTC) prescription drug Web sites, according to comments submitted to the FDA today by The Advertising Coalition in response to an April 28 Federal Register notice.
“Patients, health care providers and the industry need the FDA to provide Internet and social media guidance as soon as possible,” said John Kamp, executive director of the Coalition for Healthcare Communication (CHC). “Good research is always valuable, but guidance is what is needed right now.”
Accordingly, the comments state, “The [Advertising] Coalition encourages the FDA in the strongest possible terms to proceed with the issuance of draft guidance even as the proposed consumer surveys are undertaken.”
The comments also note that because online media are volatile, what the FDA learns about consumer preferences or comprehension today might no longer apply in the near future, that a lack of guidance may be stifling DTC outreach and that the FDA should address the permissibility of hyperlinks to provide risk information in the forthcoming draft guidance.
The Advertising Coalition represents U.S. advertisers, ad agencies, media and media-related companies engaged in the development and dissemination of DTC prescription drug advertising. The CHC participates in The Advertising Coalition through the American Association of Advertising Agencies (4As).
Industry Needs Guidance Now
The Advertising Coalition’s comments state that although the FDA may seek additional evidence to support its guidance, the agency already has enough information to develop new media guidance. Further, the Coalition asserts that the results of these FDA studies will represent only a snapshot of consumer input in an ever-changing online environment.
“Certainty is an elusive goal, particularly when it comes to studying the effects of particular executional techniques in dynamic new media that are evolving rapidly in real time,” according to The Advertising Coalition. If the agency issues guidance now, “there is surely no legal impediment to the agency’s modification of the draft guidance at a later date,” the comments state.
“The uptake of the new media by patients, caregivers and professionals is simply astounding,” added Kamp. “Industry must participate to ensure that quality information is available. FDA guidance would reduce regulatory risk and support wider industry participation,” he said.
In the wake of ongoing delays from the FDA regarding this guidance, DTC advertisers are left tracking ad hoc agency enforcement actions – Notices of Violation and Warning Letters – to determine what is and is not permissible DTC Internet promotion, a situation that can hinder the positive benefits of DTC promotion.
“While regulation through enforcement may have in terrorem effects that FDA perceives as beneficial, this approach has a correspondingly serious, chilling effect on protected speech, such as DTC communications, that FDA has acknowledged may be of high public health value,” the comments state.
Fair Balance Should Be Determined by ‘Net Impression’
The Advertising Coalition also objects to the FDA’s current enforcement position that hyperlinks are not an appropriate mechanism to provide risk information in online DTC marketing. Arnold I. Friede, Arnold I. Friede & Associates, who authored The Advertising Coalition’s comments, previously told CHC that the FDA’s “categorical rejection” of the use of hyperlinks to provide risk information is “inconsistent with the approach FDA has taken in other analogous contexts.”
Quoting a 2009 FDA guidance, the Coalition’s comments state that the FDA at that time acknowledged the need for contextualizing both risk and benefit information. “This proposition that risk communication be evaluated based on overall ‘net impression’ and what ‘the piece as a whole conveys’ is congruent with the notion that conspicuously hyperlinked risk information, depending on context, is as much part and parcel of an advertising execution as any information that appears on the face of the promotional piece itself,” according to the comments.
The comments also reference a U.S. Supreme Court case (Kordel v. United States) discussion which states that depending on context, one piece of information can accompany another and be deemed labeling without physical attachment between the two.
Additionally, The Advertising Coalition points out in its comments that the FDA should take into account the limitations of using traditional research techniques to better understand multi-faceted and fast-changing media. By the time the research results are available, the comments state, “it is virtually certain that the media being studied will have changed in ways not envisioned in the research.”
June 23, 2011 — In a victory for data gathering companies, the pharmaceutical and biotechnology industries, advertising agencies, medical publishers and other media, the U.S. Supreme Court ruled in Sorrell v. IMS Health Inc. today that Vermont’s ban on marketing use of prescription data “turns on nothing more than a difference of opinion” and that the state’s justifications for imposing “content- and speaker-based burdens on protected expression” do not withstand “heightened scrutiny.”
The Supreme Court’s 6-3 decision in favor of IMS (No. 10-779), followed oral arguments presented April 26, during which the Justices signaled that Vermont’s law was an attempt by the state to manipulate the “marketplace of ideas” on behalf of ideas favored by the state while restricting the rights of pharmaceutical companies to target doctors with truthful messages.
“This is a victory for patients as well as industry,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Although couched in terms of privacy and cost reduction, the Vermont law was a transparent attempt to censor industry speakers while enabling government and others to speak. Enlightened policy makers always knew it was a bad idea. Now, it’s clear that the ban is also a violation of the First Amendment,” he said.
“Patients are not served by censorship. Without good data, no one can make informed decisions, including doctors, patients, policy makers and industry,” Kamp continued. “This and similar state statutes were direct attacks on data gathering, analytics and use. Let’s hope the proponents of these statutes find better ways to advance their policy goals.”
Indeed, the Supreme Court’s opinion states that Vermont “may not burden protected expression in order to tilt public debate in a preferred direction.”
Entities that either joined or supported IMS in this case also are pleased with the outcome. “We have long maintained that Vermont’s prescriber data restriction law – and others like it – violate the U.S. Constitution by restricting speech in two ways: by limiting the transmission of factual and accurate information about prescribing practices; and also by limiting marketing that utilizes that information said Cathy Betz, vice president, Government Affairs, Wolters Kluwer.
“Moreover, these types of laws do nothing to improve healthcare, reduce costs or protect physician/patient privacy as proponents have claimed,” Betz noted. “Today’s ruling is a very important decision for commercial speech in general. The Court invalidated most any attempt to put limits on commercial free speech in advertising and marketing.”
Christopher A. Mohr, an attorney with Meyer, Klipper & Mohr PLLC, and counsel of record for the amicus brief filed in support of IMS by the Coalition, American Business Media, The Consumer Data Industry Association, CoreLogic, The National Association of Professional Background Screeners, and Reed Elsevier Inc. offered the following comment on the Supreme Court’s opinion.
“Today, the Court re-affirmed several basic First Amendment principles and their application to the database industry. First, it rejected any suggestion that the aggregation of information into a database renders it a commodity or ‘beef jerky.’ Databases (and the publication of the information within them) are unequivocally protected by the First Amendment,” Mohr said.
“Second, the case makes clear that the government cannot prevent the dissemination of accurate information (as it tried to in this case) by discriminating against particular speakers speaking on particular subjects. This case involved pharmaceutical information, but its implications reached far broader than that. The opinion not only protects the rights of information publishers to make information available on a variety of subjects without government interference, but also ensures that the public may receive relevant information to make better business, economic and political decisions,” he said.
The Coalition will continue to offer ongoing analysis of this decision.
June 16, 2011 – The Food and Drug Administration (FDA) should not mandate comparative effectiveness trials as part of the drug approval process, according to Scott Gottleib, a resident fellow with the American Enterprise Institute for Public Policy Research (AEI).
Gottleib, a former FDA policy head, writes in AEI’s June issue of Health Policy Outlook that the FDA should not bow to the pressure of consumer groups that are calling for across-the-board comparative effectiveness trials be added to the drug approval process, noting that these trials already are being conducted in important cases. Requiring these trials for all drugs would significantly slow down drug approval reviews, he asserts in the article. Read the full AEI Guest Column.
June 14, 2011 — The FDA proclaimed success for the first year of the “Bad Ad” program, through which healthcare professionals are asked to report suspected untruthful or misleading drug promotion to the Division of Drug Marketing, Advertising, and Communications (DDMAC). The program is so successful, says DDMAC leaders, it will be expanded, “based on the overwhelmingly positive feedback and response from the medical community.”
However, some industry lawyers are not so sure. For example, Arnold Friede, who has experience both in the FDA General Counsel’s office and at Pfizer, and who is now in private practice, said this on an industry blog: “I think the news here isn’t so much about what FDA has heard from doctors or about how many letters FDA has sent, but about the in terrorem impact of the Bad Ad program. This program gives companies yet another reason to monitor their promotional behavior,” Friede said. “The FDA is deputizing doctors to become informants. It’s like the old ‘Deputy Dawg’ show, except it’s ‘Deputy Doc.’”
Interestingly, the agency states in the report that the sheer volume of reports is not how it will measure the success of the program. Instead, “FDA’s most important measure of success for this program is the heightened sense of awareness of misleading promotion among HCPs throughout the health care community and the likely useful deterrent this awareness has on drug promoters who might run afoul of regulation absent such messaging.”
Program Expansion Plans
In an annual report released yesterday, entitled “Bad Ad Program: 2010-11 Year End Report,” the FDA states that it “expects to continue and expand its Bad Ad efforts in the coming years.” Expansion activities will include the development of a Web-based continuing education program, a focus on students and early-career health care professionals and the active pursuit of opportunities to collaborate with the nation’s medical, pharmacy and nursing schools to enhance student education, according to the report.
Healthcare marketers also should be aware that DDMAC representatives will continue to attend industry events, including this roster of trade shows:
- American Academy of Physician Assistants
- American Academy of Nurse Practitioners
- American Academy of Family Physicians
- American Academy of Pediatrics
- American College of Gastroenterology
- American Society of Health System Pharmacists
At an FDA Webinar in April, Catherine Gray, DDMAC management advisor, said that although DDMAC is charged with regulating print, broadcast and oral communications made by or on behalf of prescription drug companies, it cannot possibly “be in every discussion with every sales rep,” so it is asking healthcare providers to use the agency’s “Bad Ad” initiative to report any marketing activities that could potentially be in violation of FDA marketing rules.
Year One Results
During its first year, the Bad Ad program yielded 328 reports of questionable marketing. Of those, 188 were sent in by healthcare professionals, 116 were sent in by consumers and 24 were submitted by industry competitors; only 4 percent of reports were submitted anonymously. Five Warning Letters were issued by the FDA as a result of these reports.
June 9, 2011 — A new White Paper by the law firm Reed Smith demonstrates that the perils of social media go well beyond waiting for guidance from the FDA. The guide, free to employees of 4As agencies and other supporters of the Coalition for Healthcare Communication, can be downloaded using the link below.
“Okay, so it may be more than you ever wanted to know,” said Coalition Executive Director John Kamp. “Download it anyway, scan it, and keep it handy when the inevitable questions arise. If you don’t have a company policy, use this White Paper to help you create one now to avoid trouble for you and your clients.”
“Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon” does not focus on FDA regulation but on the broader array of legal matters that might arise with advertising and marketing; commercial litigation; data privacy and security; employment practices; government contracts and investigations; insurance recovery, litigation, evidence and privilege; product liability; securities; and trademarks.
The White Paper’s introduction warns that what used to be discussed or communicated in private now is often public, with “All of it memorialized in discoverable form. All of it available to millions with the simple press of ‘post.’”
In the advertising and marketing chapter, Reed Smith authors note that while there are many benefits to social media communications, “it’s critical to understand and navigate the legal minefields that are both dynamic and evolving as the media evolves.” Topics in this section include brand awareness (branded pages, promotions and contests) and brand interaction (bloggers, customer service/feedback, user-generated content), as well as talent compensation.
In this chapter’s “Bottom Line—What You Need to Do” sidebar, the authors state that regardless of the level of a company’s social media participation, all companies should have policies in place and that every employee should understand them. Among other uses, the policy should enable companies and their clients to “be prepared to respond to negative comments made about the company and/or its brands.”
Download the full Social Media Legal Guide here.
June 1, 2011 — Ongoing attacks on direct-to-consumer (DTC) advertising for new prescription drugs may be deflected by a recent report from the Congressional Budget Office (CBO), which states that a two year moratorium on DTC advertising “could worsen – rather than enhance – public health.”
“The CBO report recognizes the multiple factors in medical marketing and communication public policy and avoids the too prevalent negative bias of many DTC studies,” said Coalition for Healthcare Communication Executive Director John Kamp. “The report recognizes that a ban would limit the adoption of new drug options, clearly harming many patients and public health,” he said. “The CBO report helps us change the terms of the DTC debate on Capitol Hill, benefiting patients as well as sellers of new medicines.”
In its May 2011 Economic and Budget Issue Brief: “Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescription Drugs,” the CBO said a DTC moratorium would:
- Likely cause sellers to just shift marketing spend from DTC advertising to physician advertising;
- Decrease prescriptions for some new drugs; but
- Not likely change drug prices.
Addressing questions on costs and spending, the CBO found that banning DTC advertising of new drugs might have a “substantial impact on sales and use of individual drugs,” but it noted that the number of new drugs approved each year is so low that it would not have a significant impact on overall sales and use of prescription drugs. It also recognized that, despite their cost, new drugs often decrease overall spending for patient care.
Also, the CBO acknowledges that “distinguishing cause and effect between marketing and sales is difficult,” because manufacturers tend to use DTC marketing for common conditions that affect a large population. Further, drug companies subject to any ban on DTC marketing likely would shift their marketing efforts to focus more on physicians through detailing, professional meetings and journal ads.
Further, the CBO makes the point that the public benefits from DTC ads that drive individuals to their doctors for treatment, and that doctors and insurance companies play a pivotal role in determining which drugs will be used to treat those patients. In other words, DTC advertising may increase overall drug spending because it gets patients into doctors’ offices, but patients often may not be prescribed the advertised drug.
The report also includes findings regarding drug safety concerns relating to broader use of a drug following approval, including the perception that “the newest drugs on the market tend to be among the most heavily promoted, raising the risk that more people will be adversely affected before steps can be taken to identify and address such safety problems.” The CBO asserts that this same rapid uptake rate decreases the time needed to identify and address safety factors not recognized in initial clinical trials.
Accordingly, the CBO concluded that a two-year moratorium on DTC advertising for new drugs could actually “postpone the realization of a drug’s true risks – if, for example, the number of people taking the drug was reduced enough by a moratorium that the full risks were not discovered as quickly.”
A DTC drug ban also could have a negative effect on drug development, according to the CBO. “Without the possibility of DTC advertising, pharmaceutical manufacturers may see their opportunity to create a market for a first-in-class drug and to benefit from its monopoly status delayed or diminished,” the CBO stated. “That outcome could, in turn, reduce their incentive to research and develop new breakthrough therapies.”
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