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 22, 2013 – Although spending on drug promotion has declined in recent years, 2013 could be a pivotal year for the drug industry and its marketing partners. New legislative authority has spured an already energized FDA drug approval staff to focus on novel drugs. The new program, giving prioity for agents in critical areas, builds on recent progress and could signal “the beginning of a new era in drug approvals,” said Coalition for Healthcare Communication Executive Director John Kamp. “Such new drugs are great for patients and give industry new reason to energize flagging marketing programs.”
Speaking March 19 at the Drug Information Association’s Medical and Scientific Communications 2013 Annual Forum held in Chandler, Ariz., Kamp told attendees that in addition to the new drug approvals program recently adopted by the FDA’s Center for Drug Evaluation and Research (CDER), the FDA Safety and Innovation Act (FDASIA) provides incentives for breakthough products and antibiotics. These augment the biosimilar approval pathway created in the Affordable Care Act.
“It is not surprising that drug promotion rates declined in recent years as approvals slowed down,” Kamp said. “But current upward approval trends — including a recent record of 39 approvals in 2112 — combined with the CDER program to speed the approval of breakthrough products, makes it nearly certain that marketing opportunities will increase in 2013. While most of the new products are speciality products, not the blockbusters of the past, they are new products nonetheless and many will grow into substantial markets.”
But the recent numbers published by PLOS tell a different story over the past several years. The study, “Promotion of Prescription Drugs to Consumers and Providers, 2001-2010,” which was released March 4, states that a number of factors appear to have had an impact on drug promotion, which peaked in 2004 at $36.1 billion and sank to $27.7 billion by 2010. Its authors propose that those factors include a slowdown in new drug introductions, changes in the pharmaceutical pipeline, patent expiry for blockbuster drugs, and a greater number of approved biologics.
Spending on direct-to-consumer (DTC) advertising dropped from nearly $6 billion in 2006 to $4.4 billion in 2010, the study states. “During this period, television accounted for a decreasing proportion of all DTCA, declining from 62% in 2001 to 54% by 2010. Print DTCA increased 84% 2001-2006, but then declined 24% by 2010. In 2010, internet promotion accounted for less than 5% of overall consumer promotion,” according to the study summary.
“Manufacturers of branded pharmaceuticals continue to expend considerable sums on promotion to consumers and providers,” the PLOS study concludes. “However, in the context of marketplace changes, firms are decreasing spending but changing little about how expenditures are allocated across types of promotion.”
Kamp asserted that new drug development and approval initiatives will help reverse the decline in approvals that industry has seen in the past several years. For example, with FDASIA codifying accelerated approvals, innovative drugs have a better chance of being approved in a timely manner. Further, “breakthrough therapies” – those that show extraordinary clinical effectiveness – have access to “hyper fast” development, he said. And, the Generating Antibiotic Incentives Now Act (GAIN Act) provides five additional years of patent protection for qualified agents targeting priority infections.
“Add these to priority treatment for rare disease drug applications and for pediatric drugs, and the numbers surely will go up,” Kamp predicted. He also pointed out that during the past two years, FDA new drug approvals have increased from where they stood in 2010. [Editor’s note: The recent study did not tabulate spending data after 2010.]
Kamp described the new approval system – known as “The Program” – as including the following features:
- Longer review cycles, but faster review times;
- Better meetings, including outside consultants that will report on system
- More late-cycle meetings to avoid “surprises” to drug sponsors;
- Fewer, “less exciting” Advisory Committee meetings; and
- Fewer late-cycle “complete response letters” and demands for new studies.
How all of the new approval system changes will stack up against some of the current market challenges remains to be seen, but, Kamp told DIA Forum attendees, “the greater number of approvals for new drugs that we saw in 2012 – with even more new drug approvals likely in 2013 – is most definitely an encouraging trend.”
March 4, 2013 – A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed drug promotion increases utilization and thus overall drug costs, it also helps to educate consumers, induce physician contact and promote adherence.
“It’s refreshing to see a balanced study of DTC,” notes John Kamp, Executive Director of the Coalition for Healthcare Communication. “Safe and effective use of drugs is good for patients and, in the long run, can save money,” he said.
The February 2013 NBER study report discusses the role of promotion to both consumers and physicians and whether such promotion is persuasive and/or informational. The study presents empirical evidence that pharmaceutical promotion has both informative and persuasive elements; it states that physician advertising is “primarily persuasive in nature, effectively increasing selective brand demand.” However, “there is no strong indication that either consumer- or provider- directed promotion substantially raised retail-level prices,” according to the study.
Study author Dr. Dhaval Dave, associate professor of economics at Bentley University and research associate for the NBER, told the Coalition that there “may be several potential benefits associated with pharmaceutical advertising.” Specifically, he stated that “advertising directed at consumers can expand the total market for drug treatment by educating consumers with regard to treatment options for their symptoms, by facilitating contact between the patient and the physician,” and by reminding patients who already have prescribed medications to adhere to their drug therapy.
“Thus, in one sense, consumer ads can avert underuse and expand treatment to undertreated/under-diagnosed conditions,” according to Dave.
For the most part, he continued, physician-directed promotion “has been shown to mostly have brand-specific effects rather than expanding the total market for the therapeutic class. Though, at least in the beginning phases of a drug’s launch into the market, provider-directed promotion may have some informational content and may help to educate physicians regarding the availability of newer drug treatments, and their indications and contraindications.”
The study found that toward the buy cialis online later stages in the drug’s life cycle, provider-directed promotion tends to be more persuasive in nature, and aimed at providing samples and reminding physicians to continue prescribing the drug.
“These benefits also need to be balanced against some potential costs relating to possible overtreatment – prescribing the more expensive, advertised drug in lieu of more effective or less-costly unadvertised drugs, and potential misuse from expanding the market such that more marginal patients, who may be at greater risk of contraindications, are being
treated,” Dave asserted.
Read more about this study in Medical Marketing & Media: http://www.mmm-online.com/meta-survey-suggests-favorable-riskbenefit-profile-for-dtc-ads/printarticle/281989/. To view study abstract, go to: http://www.nber.org/papers/w18830.
Dec. 3, 2012 – Several industry advertising experts have weighed in regarding what message drug companies should take from a recent study published in Cancer regarding the impact of direct-to-consumer (DTC) advertising for aromatase inhibitors (AIs). The study, released in November, found that DTC advertising (DTCA) for AIs “was associated with increases in appropriate prescriptions with no significant effect on inappropriate prescriptions,” and noted that DTCA “may actually be beneficial.”
“This study demonstrates that DTC advertising helps get patients the right drugs to treat their conditions,” said Matt Giegerich, Chairman & CEO, Ogilvy CommonHealth Worldwide and Chair-elect of the Coalition for Healthcare Communication (CHC). “Let’s hope that public policy makers read and understand that this peer-reviewed research demonstrates that marketing often leads to more effective patient care.”
Jim Davidson, Executive Director, The Advertising Coalition, told the CHC that the study “seems to recognize what we’ve been saying for years: That DTC advertising is very important to the dialogue between doctors and patients.”
Davidson explained that this study, among others, helps to support the First Amendment argument that making more information – instead of less – available to the public is beneficial. “Any time we try to take information off the table and keep it away from consumers we do them a disservice,” he said. “We all perform better when we are armed with information.”
John Kamp, Executive Director of the CHC, noted that because
the report summarizes peer-reviewed research and is not initiated or supported by industry, “it is strong evidence supporting the value of marketing in
the delivery of appropriate care, blowing away much of the unsupported criticism that marketing leads to inappropriate prescribing. Though critics may well continue their refrain, this study proves it’s out of tune with solid evidence.”
The Cancer study authors state that although “the literature largely demonstrates that DTCA increases demand … it is unclear whether this increase is ultimately beneficial or harmful to patients.” They attribute this ambiguity to the difficulty in defining “appropriate and inappropriate use in an easily measurable way for most medications advertised in this manner.”
The researchers chose to study the effects of DTCA for AIs, a class of oral breast cancer therapies that reduce the risk of cancer recurrence in postmenopausal women – an appropriate use – because the drug also has a corresponding inappropriate use in the premenopausal population. As such, patient age could be used as “strong proxy for menopausal status” and as a “surrogate marker of appropriateness.”
The hypothesis for the study, which tracked prescription data from October 2005 to September 2007, was that there would be a significant increase in AI use associated with DTCA in all age groups, “both for older women, for whom this treatment is appropriate, as well as for younger, presumably premenopausal women for whom such treatment is inappropriate.”
However, the researchers found “that increases in DTCA for the AIs prompted prescriptions only in the patient population for whom they were appropriate,” which they state is due either to “perfectly successful targeted marketing” or, more likely, to physicians selectively blocking “the effect of advertising-induced interest in these agents among patients for whom they would be medically inappropriate.”
If the latter is the case, DTCA might be having a negative effect on the time management of physicians who have to spend time with patients explaining why a specific medication is not right for them, the authors state. However, Davidson suggested that for both patients and doctors, “the single most valuable resource is time, and it takes a lot less time to explain a condition and treatment options when a patient is knowledgeable.”
He added that the study also underscores the role of a doctor as a learned intermediary. “Doctors clearly are fulfilling this role as it was anticipated,” he said. “And most doctors would rather have an educated patient, even if they have to explain a condition further and redirect a patient” to a medicine that better suits his or her condition.
The study authors do speak to these benefits, stating that “DTCA may also have positive effects in addition to the increased demand for appropriate medication use that we found, such as increases in high-priority diagnoses, fostering medication compliance and encouraging patients to communicate with their physicians.” However, these benefits “are not well-characterized and merit further study,” they note.
The researchers conclude that their data suggest “that this controversial form of medical communication may not be harmful for certain classes of drugs such as cancer medicines.”
Oct. 10, 2012 – Coalition for Healthcare Communication Executive Director was quoted in an article in Beyond the Pill that discusses the Pharmaceutical Care Management Association’s recent
proposal to ban the
DTC tax deduction “as one step in a plan that ‘leverages’ pharmacy benefit management tools as a way to save more than $100 billion in Rx drug costs over 10 years.”
“Marketing costs, like heat, lights, water and employee costs, are part of the ordinary and necessary cost of any business,” including those who dispense drugs as well as those who innovate and make them, according to Kamp. “PCMA should look elsewhere for savings to avoid the fiscal cliff, lest they take their members and us over a different cliff at least as dangerous as the one they seek to avoid.”
Read more at: http://beyondthepill.medivo.com/2012/10/pbm-group-proposes-again-ban-on-dtc-tax-deduction/
June 21, 2012 – The Food and Drug Administration (FDA) announced yesterday that it intends to study whether providing disease awareness information in branded full product advertisements affects consumer perceptions of the product.
In a June 20 Federal Register notice, the agency stated that although some research has shown that disease awareness advertising “is viewed by consumers as more informative and containing less persuasive intent than full product advertising,” when that information is included in branded product ads, “a full description of the medical condition may include information about specific health outcomes that are not part of a drug’s approved indication.”
“Although the FDA can investigate these matters, it might be better to study the behavioral response to both disease awareness and product advertising, as well as the value of ads to educate and better inform,” said Coalition for Healthcare Communication Executive Director John Kamp.
Arnie Friede, former Senior Corporate Counsel at Pfizer, Inc., and a former Associate Chief Counsel in the FDA Chief Counsel’s Office, told the Coalition that “there is an important opportunity here to stake out a position on the utility from a public health standpoint of advertising that couples disease awareness information and product promotion and to argue that FDA should revisit its enforcement policy on the matter even as it undertakes and evaluates the consumer survey,” he said. “This is also consistent with Commissioner Hamburg’s position that industry ought to consider doing more disease awareness advertising.”
The agency is concerned
that “consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement.” The FDA notes that if consumers have difficulty distinguishing between disease awareness information and branded drug product claims, consumers “may be misled.”
The study that the FDA is proposing to conduct will explore perceptions that result from including both disease information and promotional information about a specific drug in the same advertising piece. Two variables will be examined in the study: (1) the type of disease information (possible disease outcomes, versus non-outcome information, versus no information); and (2) the format of the information (integrated with drug information versus separated).
Although a comment sent in
response to an Aug. 16, 2011, notice for public comment requested that any survey questions related to behavioral intention be deleted, the FDA states in the notice that its Risk Communication Advisory Committee (RCAC) has recommended that behavioral intention is an important variable to measure in research studies on promotion. [Editor's
note: The RCAC is slated to meet again on June 29 from 8 a.m. to 3 p.m.]
“What is most important now is developing public policies that enable optimal use of life enhancing and life saving medicines,” Kamp said. “It’s time to focus on more effective ads, leading to safe, effective use and better adherence, rather than just focusing on problems with ads.”
Comments regarding the proposed study are due to the FDA by July 20.
June 20, 2012 – First quarter 2012 data from Nielsen show that direct-to-consumer (DTC) ad spending fell 14 percent, continuing a downward trend that started
several years ago, according to a June 19 article in Beyond the Pill. The article, “Marketers Continue Trimming DTC Advertising Spending in First Quarter,” highlights the big brands that continue to spend heavily on DTC promotion and concludes that “many of the smaller brands are opting out of the big DTC campaigns in favor of better targeting that should produce a better return on investment.”
“It’s not that
medical marketers are retreating from DTC, they are just being smarter about its use,” remarked Coalition for Healthcare Communication Executive Director John Kamp. “This industry is changing before our very eyes – mostly for the better – because companies and their agencies are using data and intelligence to promote the most effective messages in the most effective media directed at the most important audiences,” Kamp said.
For the full article, go to: http://beyondthepill.medivo.com/2012/06/marketers-continue-trimming-dtc-advertising-in-first-quarter/
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.
March 5, 2012 – In a case that highlights First Amendment limits to FDA regulation of marketing, the U.S. District Court for the District of Columbia granted a motion for summary judgment Feb. 29 in favor of five tobacco companies who called unconstitutional an FDA rule requiring that new, mandatory graphic images be added to specific textual warnings included on cigarette packaging.
“The Court concludes that these mandatory graphic images violate the First Amendment by unconstitutionally compelling speech,” U.S. District Judge Richard J. Leon wrote in the court’s opinion (Civil Case No. 11-1482 (RJL)).
“If courts refuse to allow this sort of regulation of tobacco products, which cannot be used safely, it’s fair to assume that many other FDA regulations governing speech are at risk. The court’s decision reminds us that the bar for restricting speech is high,” said John Kamp, Executive Director, Coalition for Healthcare Communication.
“While the tobacco regulations were unprecedented, if the FDA can’t get tobacco restrictions past the courts, how can it possibly continue to restrict medicine companies from telling the truth about the off-label uses of their products?” Kamp continued.
The tobacco companies successfully argued that the congressionally mandated graphic warnings unconstitutionally compel speech, “and that such speech does not fit within the ‘commercial speech’ exception” allowing certain types of government-mandated, informational disclosures. In legal terms, the court decided that these mandated warnings had to be analyzed under the “strict scrutiny” test of First Amendment law and that the rules failed that standard.
Stating that the FDA rule’s graphic-image requirements are not the type of purely factual disclosures that are reviewable under a less-stringent standard, the court found that the FDA failed to satisfy the burden of demonstrating that its rule is narrowly tailored to achieve a compelling government interest and, thus, violated the First Amendment.
“While the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for Government advocacy can be frustratingly blurry, here the line seems quite clear,” the opinion states.
In light of the court’s decision, “it’s fair to ask how the increasingly intrusive ‘fair balance’ disclosures would fare under the ‘compelled speech’ theory applied in this case,” Kamp said. “Even more importantly, it’s time for the industry to ask whether the compelled disclosures do more harm than good to the public health.”