By John Kamp, Executive Director, Coalition for Healthcare Communication
June 28, 2012 – In a 5-4 decision, the U.S. Supreme Court today upheld the mandate in the Affordable Care Act (ACA) that nearly all individuals purchase health insurance
or face penalties. However, the Court restricted the federal government from withdrawing all Medicaid funds to states that do not comply with the Act’s new coverage requirements.
With the exception of the Medicaid provisions, virtually all major provisions of the ACA stand, including the drug discount and other provisions supported by PhRMA, the pathway for approval of follow-on biologics, the Sunshine Act (which creates the national registry of payments to physicians), and the extension of care and medicine to as many as 30 million additional U.S. citizens.
This decision, much discussed by news pundits, may conclude this particular case, but it will not end the debate over health care in this country during the Presidential election and beyond.
For the medical agency and publishing industries, the decision means that efforts to prepare for the implementation of the ACA provisions will continue, but that close attention must be paid to possible legislative changes and the adoption of new rules to implement its most relevant provisions.
Meanwhile, the most significant facts facing the biopharmaceutical and device industries will be the continued pressure by the government and all payers to reduce prices, as well as continued criticism by some policy makers of company
relationships with industry and of professional communication and consumer marketing.
June 26, 2012 – The FDA’s Risk Communication Advisory Committee is meeting Friday, June 29, to discuss recent research on communicating and understanding uncertainty, as well as
risk perception in low-income populations with multiple risks.
According to discussion topics for the meeting issued by the agency, the RCAC would like to get answers to the following questions:
The RCAC meeting will be held at FDA’s White Oak Campus (10903 New Hampshire Avenue., Bldg. 31, Conference Center Room 1503, Silver Spring, MD), from 8 a.m. to 3:30 p.m. The meeting also can be viewed remotely by logging on to: https://collaboration.fda.gov/rcac/.
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/
June 15, 2012 – The Coalition for Healthcare Communication joined other major marketing trade groups asking the Senate Committee on Appropriations to “delete” a directive from the Financial Services
and General Government Subcommittee which would mandate that the Federal Communications Commission (FCC) and the Federal Trade Commission (FTC) issue consumer best practices for protecting personal information over wireless networks, among other privacy action steps.
“Hats off to the leading industry lobbyists who discovered this ‘stealth’ piece of legislative language and enabled industry to interpose a timely objection,” said Coalition Executive Director John Kamp. The letter was signed by several organizations in addition to the Coalition, including the American Association of Advertising Agencies, the Direct Marketing Association, the Association of National Advertisers and the Interactive Advertising Bureau.
In a June 14 letter to Appropriations Chairman Daniel Inouye (D-Hawaii) and Appropriations Vice Chairman Thad Cochran (R-Miss.), the groups state that this directive, which was passed for inclusion in the FY 2013 general appropriations bill by the Subcommittee “without input from the committees with jurisdiction over the FTC and FCC, … is unnecessary and could have significant and negative impacts on the affected industries and American commerce generally.”
“At least two Senators have already noted the industry letter in subsequent debates and we are optimistic the language will be omitted,” Kamp noted. “Although we recognize that privacy is a critical issue for both
consumers and industry, such regulation must be carefully drafted to enable a vigorous Internet marketplace and to enable citizens to protect legitimate privacy interests,” he said.
Specifically, the signatories to the letter assert that the Subcommittee is trying to enact legislation through the “back door” of an appropriations bill, that the committees of jurisdiction have not held hearings or approved legislation in this area, and that any new legislation regarding the complex issue of consumer privacy should be fully deliberated by Congress. Allowing the provision to be included would not give industry and consumer stakeholders any opportunity to provide their views, the letter states.
The groups also argue that consumer privacy already is protected by existing consumer protection laws and industry self-regulation, and that federal initiatives – from both the White House and the FTC – have proposed other methods for addressing mobile privacy.
Further, “the White House and the FTC have specifically recognized the merits of industry self-regulation for addressing consumer privacy concerns in rapidly evolving markets and technologies,” the letter states. Such self-regulation efforts to protect consumers’ privacy online include the Digital Advertising Alliance’s Self-regulatory Program for Online Behavioral Advertising and its “Your Ad Choices” public education advertising campaign. For more information, see http://www.cohealthcom.org/2012/03/28/ftc-to-industry-adopt-consumer-privacy-best-practices-now/
“Self-regulation can address privacy concerns without interfering with innovation, which benefits consumers by delivering paychecks, savings, and exciting products and services,” according to the letter. “In contrast, new regulatory restrictions could stop innovation, slow economic growth, reduce benefits for consumers, and result in job losses.”
As such, the groups ask that the directive be removed from the legislation and that “no funds appropriated in the bill … be used by the FCC or FTC to draft new privacy guidelines that have no statutory foundation and could harm American companies and consumers.”
June 13, 2012 – In a recent blog entry on Drugwonks.com, Center for Medicine in the Public Interest President and Co-founder Peter Pitts provides a link to his article on government detailing in a recent issue of the Drug Information Journal (http://media.drugwonks.com/media/attachments/4fd748c92017a87e7400000c.pdf?1339508937).
In the article, Pitts states that this so-called “academic” detailing
is important to understand because “significant government funding has been provided to develop and roll out academic detailing programs.” This matters, he states, because the federal government “is spending tens of millions of tax dollars to tell American physicians how to practice medicine based on comparative effectiveness studies that are commissioned without any public input or transparency.”
To view the Drugwonks.com blog entry, go to: http://drugwonks.com/blog/government-detailing-by-number
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.”
June 4, 2012 – In recent comments to the FDA regarding a draft guidance that would call for prior review of six categories of direct-to-consumer (DTC) television ads, the Pharmaceutical Research and Manufacturers of America (PhRMA) stated that it is “concerned” that the FDA’s proposal infringes on the drug industry’s First Amendment rights.
Coalition for Healthcare Communication Executive John Kamp predicted back in April that a First Amendment challenge to the draft guidance – which describes the full array of DTC TV ads the FDA intends to make subject to a pre-dissemination ad review provision mandated by the Food and Drug Administration Amendments Act of 2007
– was possible. See http://www.cohealthcom.org/2012/04/09/fda-draft-guidance-on-dtc-tv-ads-raises-important-questions/
“I suspect the draft guidance will spark some interesting comments,” Kamp said in an April 9 column on the Coalition Web site. “Indeed, the guidance may be challenged under a provision in the FDA statute limiting pre-reviews, or perhaps even more dramatically as a violation of the ‘prior restraint’ limit on speech under the First Amendment.”
According to PhRMA, the draft guidance is, “in important respects, overbroad, unduly burdensome and lacking in narrow, objective, and definitive standards” and should be withdrawn, with any new proposal implemented “by means of notice and comment rulemaking in a tailored, risk-based approach that conforms with the Supreme Court’s directive [in Central Hudson] that ‘the First Amendment mandates that speech restrictions be narrowly drawn.’”
To support its position that pharmaceutical marketing is a form of speech protected by the First Amendment, PhRMA cites the June 2011 U.S. Supreme Court decision in Sorrell v. IMS Health and states that “DTC promotion – like other forms of advertising and promotion – is commercial speech that is protected by the First Amendment.” Later in the comment, PhRMA states that it is “concerned that FDA’s proposed pre-dissemination review of DTC television advertisements raises significant First Amendment concerns.”
PhRMA and industry commenters on the draft guidance also take issue with the FDA’s proposal that companies submit final recorded versions of TV ads before they are disseminated. “The requirement to submit a final recorded version of a TV advertisement will place a substantial financial burden on submitting companies,” because any FDA comments could force a company to “rework material that has already been fully produced at a significant cost,” PhRMA’s comment states.
This sentiment is echoed in other comments which assert that annotated storyboards of proposed TV ads should suffice for pre-dissemination review.
“The costs of submitting final broadcast ads and then re-shooting them because the FDA takes issue with a few aspects of the ads would most certainly be prohibitive,” Kamp said. “If this provision remains, it would be a huge blow both to industry and to the consumers who seek information about promising treatments.”
The comment period on the draft guidance closed May 14. “FDA’s next steps should be very interesting,” Kamp noted.