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. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care Act – known as the “Sunshine Act” – to ensure that the data submitted under the Act are accurate and are placed in the proper context for public understanding, according to the Coalition for Healthcare Communication Sunshine Act Comment submitted to the Department of Health & Human Services (HHS).
“Although the Coalition understands the importance of transparency, there are numerous issues that need to be resolved – and further commented on by all stakeholders – if the rule is to fulfill its intended purpose,” said Coalition Executive Director John Kamp. “To get transparency right, the HHS must do a further notice on accuracy and context,” he asserted.
The Coalition is concerned that the current proposal would have a chilling effect on important collaborations between industry and healthcare providers, lead to unnecessary and significant complexities, increase costs and create public perception issues. These concerns “must be addressed fully before final rules are adopted,” according to the Coalition comment.
“Rubber-stamping the proposal as written would be a huge mistake that, ultimately, would hurt, rather than protect, patients,” Kamp noted, adding that the public perception issues are particularly important.
“It’s time for the press and some politicians to stop treating every reported payment as a newly uncovered scandal,” he said. “The real scandal is the demonization of collaborations between industry, academia and government. Collaboration has enabled the great medical breakthroughs that have added 10 years to the average American life in just a generation.”
In addition to the call for a further notice on accuracy and context, the Coalition’s comments focus on several areas needing additional refinement and review, and make the following recommendations:
- HHS should hone the rules to more accurately reflect the legislative intent and the specific language of the statute, and “narrow its burdens and reach” accordingly. The Coalition cites indirect payments and vital prescriber education as examples of how HHS has expanded its purview under the proposed rule.
- HHS should take a closer look at the costs associated with the proposal, including the significant cost of industry and provider compliance. The Coalition believes that HHS has underestimated the direct compliance costs and largely ignored the indirect “intangible costs of possibly misleading patients, caregivers and professionals regarding the nature and value of these relationships.”
- HHS should clarify explicitly in the final statement of the rule that commercially supported meetings and educational enduring materials are not intended to be covered by the statute and are not subject to any reporting requirement.
Further, because many details of the proposed rule are unknown, the Coalition is concerned that entities involved in the medicines industry will simply avoid many collaborative programs that provide healthcare providers with valuable professional education. Such a result “would harm, not help, patients,” Kamp said. “There is a lot more work to be done.”
Feb. 13, 2012 – Dr. Robert Temple, the unofficial dean of drugs at the FDA, recently addressed one of the most perplexing issues in the post-health reform era – industry’s ability to fully participate in policy and pricing discussions on comparative effectiveness research (CER).
Companies are well aware that false or misleading CER findings can adversely affect their drugs’ prospects and this issue is becoming even more important as the federal government begins to fund more than a billion dollars of CER. However, some companies may believe that challenging CER findings is not allowed under FDA advertising and promotion regulations.
However, according to “The Pink Sheet” Daily, Temple, the Center for Drug Evaluation and Research deputy director for clinical science, said at a Feb. 9 conference that the FDA’s regulations do not preclude companies from challenging CER results that are false or misleading.
“Thank goodness Bob understands the problem and blasted open Pandora’s Box,” said Coalition Executive Director John Kamp. “Bob’s opinion is important, but not the last word, nor is it the opinion of most industry lawyers. The industry needs an official signal from the FDA that its participation in these discussions is appropriate and consistent with FDA marketing regulations.”
Temple said that FDA does not hold a view “that drug companies are condemned to silence about their products outside of formal promotion or perhaps published articles. If there’s something published that seems wrong, is based on poorly designed meta-analysis and so on, I don’t see any impediment to answer that and companies do answer that all the time.”
Temple did also note that companies must ensure that any rebuttal of CER findings are not promotional in nature, and that they should simply offer information and education about a product that is true to the product’s approved labeling.
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.
Feb. 3, 2012 – There are just 10 days left to comment on an FDA draft report that explores the best way to present risk and benefit information in prescription drug ads.
The draft report, “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review,” which was made public at the end of 2011, attempts to provide insight regarding the value of quantitative data, how the presentation of the data influences patients’ and clinicians’ processing and understanding of risks and benefits, and whether a “Drug Facts” box on promotional labeling or print advertising would improve healthcare decisionmaking.
Three key literature review findings in the report – issued by RTI International on behalf of the FDA – are:
- Numeric presentation of risk/benefit information appears to have had a positive impact on several outcomes relative to non-numeric presentation of risk/benefit information.
- No specific, single format, structure or graphical approach emerged as consistently superior.
- Numeracy and health literacy are variables that deserve more empirical attention, because results may vary for different people depending on their numeracy and literacy levels.
RTI notes in the report that there are important gaps in the current literature, such as a predominant focus in the literature on risk information alone versus studies of both risk and benefit information. However, the report states that evidence suggests “that using relatively simple presentations of numeric and non-numeric information appears to be important to prevent overwhelming viewers, regardless of the specific approach employed.”
The agency is accepting both electronic and written comments referencing on the literature review report (referencing Docket No. 2011-N-0813) by Feb. 13. The Coalition for Healthcare Communication is seeking input from the community to inform its comments, and also encourages industry entities to comment to the agency directly. To share your perspectives with the Coalition, please contact Coalition Executive Director John Kamp at jkamp@cohealthcom.org.
Feb. 2, 2012 – More than four hours of testimony before the House Energy and Commerce Committee’s Subcommittee on Health — and members’ follow-up – nearly exhausted the issues related to the Prescription Drug User Fee Act V (PDUFA V) legislation yesterday, but just one question focused on drug marketing.
“It has taken hard work so far to keep direct-to-consumer [DTC] and other marketing on the back burner in PDUFA V,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “But I’m still worried. Consumer and other groups pressed FDA at several points last year in the FDA phase. I don’t think they are going to give up now, so we’re watching carefully and remain prepared for a challenge.”
During the Feb. 1 hearing, medical marketing was raised just briefly. “Do you actually have any resources for DTC advertising monitoring to ensure that consumers do have a balanced understanding of the drugs and the risks advertised to them and the accuracy of those?” Rep. Jan Schakowsky (D-Ill.) asked Commissioner of Food and Drugs Margaret Hamburg, M.D. “Where are we with monitoring these DTC drug ads?” she queried.
“We do have a group that is charged with working on the oversight of DTC advertising and there is a process that involves the screening of the DTC advertisements,” Hamburg said, adding that “we don’t have fees associated with that.” Hamburg explained that although advertising was considered in previous PDUFA negotiations, “it is not part of PDUFA V.”
Hamburg said she gathered “that in the last PDUFA negotiation this had been identified as a possible area of focus, but actually including it was moved away from for a number of reasons that I think may have included the willingness to … include budget authority.”
“Hamburg’s response is right and appropriate,” Kamp said. “May it be the last word. However, we’re not betting the farm,” he added.
Indeed, although the exchange between Schakowsky and Hamburg was the only mention of drug advertising during this comprehensive hearing, it is unlikely to be the last, especially considering Schakowsky’s ending remark: “Given the prevalence of those ads on television, I would think that should be a major focus and I hope we can work together to make that happen,” she concluded.
Recent efforts by other entities to push for drug marketing restrictions or greater regulation of DTC ads as a part of PDUFA V are worth noting. An Aug. 31, 2011, letter from the Pharmaceutical Care Management Association (PCMA) to the Joint Select Committee on Deficit Reduction called suppressing the use of branded drugs and eliminating the tax deduction for DTC advertising “debt-reducing solutions” that it claims, combined with other prescription drug measures, could save the federal government $100 billion over 10 years.
In highlighting the PCMA recommendation to ban the DTC advertising tax deduction, the letter states that “while the First Amendment allows for such advertising, it does not require tax payers to subsidize promoting the most expensive drug treatments.”
Further, a last-minute plea from a coalition of consumer groups to Department of Health & Human Services Secretary Kathleen Sebelius asked that more marketing rules – including expanded capacity for monitoring of DTC advertising – be added to PDUFA V language.
In tandem, these proposals forward the view that further discussion of marketing in the context of PDUFA reauthorization legislation is likely to rear its head again.
“Once groups like PCMA and Consumers Union take a position, they seldom give up easily,” said Kamp. “It would be naïve to think that our fight is over.”
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