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.”
Jan. 27, 2012 – The Digital Advertising Alliance (DAA) last week launched its “Your AdChoices” public education campaign to inform consumers about interest-based advertising and how to take greater control of their online privacy. This campaign follows several years of work by industry association leaders to develop and implement cross-industry best practices and effective solutions for the collection and use of advertising data.
The self-regulatory program and ad campaign respond to the increasing consumer angst about privacy and multiple proposals by Congress, the Federal Trade Commission and the Department of Commerce to limit online tracking and targeting by marketers.
“The Internet is THE marketing tool of our age, but if we don’t respect consumer privacy preferences, consumers and the government will shut us down,” said John Kamp, executive director of the Coalition for Healthcare Communication.
“The self-regulatory program created by the DAA and this ad campaign put us on the right track. However, we must deliver on our promise both by helping consumers fully understand the advantages to them of digital tracking and by respecting their decisions to opt out when they wish,” Kamp commented.
The Coalition opposes mandatory “Do Not Track” provisions introduced in multiple pieces of legislation crafted by the Congress in 2011, but also strongly supports industry self-regulation that enables easy consumer opt-outs of unwanted tracking and marketing. [For more information about the DAA program, go to: http://www.aboutads.info/.]
Currently, more than 400 companies participate in the DAA’s Self-Regulatory Program for Online Behavioral Advertising – including many top-20 global advertisers.
“Because medical data is particularly sensitive, medical marketers must be among the first to adopt the self-regulatory program and show our customers that we can be trusted to deliver useful information while respecting their privacy,” Kamp asserted.
“With widespread industry adoption of the [program] principles, the DAA remains committed to informing consumers about interest-based advertising, online data collection and use, and the simple way they can exercise control over their Web viewing data,” said Peter Kosmala, DAA managing director. “This highly creative public education campaign is an important step in that ongoing process.”
However, the threat of Congressional or federal agency regulation remains real. The advertising industry is expecting a final report on online privacy from the FTC and the White House is putting together its own report on digital privacy during 2012. The DAA’s consumer education campaign may be criticized in these reports for not sufficiently stressing the opt-out function.
Based on extensive consumer research, the campaign videos were created pro bono by MRM of Salt Lake City, part of McCann World Group. The first part of the campaign stresses how online advertising can result in advertising more targeted to individual consumer interests, leading some to object. A Jan. 19 article in The New York Times was critical of the videos because they “fail to mention … that users can opt out of being the target of personalized ads.” Writer Tanzina Vega states in the Times that “far from encouraging users to opt out, the ads emphasize how information that advertisers gather actually can improve the quality of the ads users see online.”
“The Times criticism is not completely fair,” according to Kamp, “but it is indicative of the skepticism out there. We must do this right and well, and the clock is ticking. What we don’t want is an EU-like privacy regulatory scheme which mandates informed consent for use of any cookies on a consumer brouser. That could kill much effective U.S. marketing.”
Jan. 26, 2012 – Avoiding conflict of interest in continuing medical education (CME) may seem like a daunting task, but companies can produce high-quality CME programs that skirt commercial bias if they implement several key strategies, including peer review, according to a recent article in Medical Marketing & Media.
The article describes a newly released video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – which includes the views of prominent CME stakeholders.
In the video, Coalition for Healthcare Communication Executive Director John Kamp states that “Providers of CME are following the rules. And things are getting better all the time in this area because people are essentially educated.”
The video stresses that peer review is an important tool in both resolving conflict of interest and ensuring high-quality content, the MMM article states.
“Resolution of COI is really pretty easy,” Kamp said. “If someone has a conflict on something they’re speaking about, they disclose it. And we make sure, as much as possible, using peer review and other ways, that it’s not a biased review or use or suggestion on those drugs,” he added.
To read the full MMM article, go to http://www.mmm-online.com/video-reflects-struggle-to-keep-bias-out-of-cme/article/224031/
Jan. 20, 2012 – Common sense should tell people that some of celebrity chef Paula Deen’s infamously unhealthy dishes – a burger topped with a fried egg served between two glazed donuts or a “Fat Darrell Sandwich,” which combines chicken fingers, french fries and breaded mozzarella sticks on a large roll – should not be a routine part of anyone’s diet, diabetic or otherwise.
However, this week pharmaceutical company Novo Nordisk has taken some heat over its relationship with newly announced type 2 diabetic Deen, who is known for her decadent, high-fat, high-sugar recipes.
“Bring on the controversy,” says John Kamp, Executive Director of the Coalition for Healthcare Communication. “Who better than a notorious sinner to address the congregation?”
Deen, who recently launched a Web site, http://www.diabetesinanewlight.com, sponsored by Novo Nordisk, has had Type 2 diabetes for three years, but came forward with the information only as the new site went live. She and her sons, Bobby and Jamie Deen, also will be featured in a Novo Nordisk ad campaign which begins Jan. 25.
Many colleagues, media outlets and Deen fans are criticizing her for withholding her status as a diabetic while she continued to promote recipes that do not support a healthy lifestyle. They also appear to find it unseemly that she did not reveal that she was a diabetic until she had become a part of the Novo Nordisk campaign featuring Victoza, which Deen uses to treat her condition.
Some publications also are using this negative feedback as an opportunity to sour the pharmaceutical industry on celebrity endorsements, which is ill-founded, according to Kamp.
“For better or worse, we all listen to celebrities. If Paula Deen helps people recognize the dangers of diabetes, spurs people to pay attention, talk to their doctors and develop better eating habits, then good for her!” Kamp remarked. “As individuals and as a society we need every tool possible to cope with diabetes. Drugs are part of the toolkit, so by all means, let’s talk about it.”
Indeed, as Matthew Herper wrote Jan. 17 on Forbes.com, “it’s just as likely some patients will see Deen as a fellow traveler, different from the doctors and health nuts who are lecturing them about what they eat. Even as the cognoscenti whine about Deen’s cooking, the deal will help Novo-Nordisk sell drugs.”
While Herper contends that the campaign “may cost the drug industry as whole credibility in the long-term,” he also notes that “Novo would not be bothering with Paula Deen if it didn’t think she could help sales. And the fact that the deal went down despite all the naysaying is proof that we haven’t seen the last pharmaceutical ad campaign built around a famous face.”
Camilla Lee, corporate vice president, Diabetes Marketing at Novo Nordisk, said in a statement that the company is “thrilled that Paula, Bobby and Jamie Deen are part of this initiative that helps people embrace diabetes management in a more positive way.”
The American Diabetes Association (ADA) also expects that the company’s ties to the Deens will result in more people seeking treatment for their diabetes. “People may benefit from seeing how others successfully manage type 2 diabetes,” said Geralyn Spollett, MSN, ANP-CS, CDE, president, Health Care & Education of the ADA. “Paula Deen, through her work with ‘Diabetes in a New Light’ is likely to inspire many people living with type 2 diabetes to take a more positive approach to their diabetes care.”
Perhaps in response to the backlash her involvement with the Novo Nordisk campaign, Deen announced Jan. 18 that she is pledging a portion of her earnings from the Novo Nordisk endorsement deal to the ADA.
Bottom line, whether the celebrity is Paula Deen for Victoza or Joan Lunden for Claritin, celebrity endorsements can shed light on common health problems, raise awareness of serious health conditions and lead to more people seeking treatment and looking for lifestyle changes – such as putting a healthier spin on favorite Southern recipes – that can improve patients’ daily lives and long-term prognosis.
“Celebrities are controversial and focus our attention. Let’s hope this controversy helps focus attention on the dangers of diabetes, spurs better doctor/patient conversations, and maybe even sends some of us to the gym,” Kamp said. “Meanwhile, please point me to that healthy french fry recipe. I’m getting hungry.”
By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication
Jan. 17, 2012 – The Affordable Care Act (ACA), passed to improve America’s healthcare system and reduce its costs, included the “Sunshine” provision to create a national registry of payments and transfers of other items of value from healthcare manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals. Recently, the Centers for Medicare & Medicaid Services (CMS) released a Sunshine Act Proposed Rule to implement the provisions and is soliciting public comments to be considered before final rules are published later this year.
The Coalition supports the purpose behind the Sunshine provision of the ACA – the transparency of relationships between industry and health care providers – but is very concerned that the current plan for implementation by CMS will create unnecessary compliance burdens and defeat the purposes of cutting healthcare costs and improving patient care. The Coalition also is worried that the burdens imposed by the proposed regulations will dissuade healthcare providers from participating in continuing medical education (CME) and other important relationships with industry
After reviewing the proposed rule, the Coalition is troubled that the endpoint of the proposed rule may be a sea of granular information that could cost billions of dollars over the next 10 years. The taxpayers will bear both the direct costs of the government administration of the program and the indirect costs of compliance by the medicines industry. There is little evidence to suggest that the program will improve the healthcare system or control costs.
CMS Proposed Rule
CMS’ proposal to implement the law enacted by Congress is incredibly complex and detailed, illustrating the complexity of this transparency initiative. This complexity and the attendant costs of compliance should cause rational people to step back and question whether these rules really contribute to better healthcare or simply are another government mandate that is likely to create several unintended consequences that may end up harming patients.
The 120-page CMS document deals largely with the administrative aspects of implementing the regulation. Compliance will cost the companies, the government and, ultimately, patients and taxpayers, millions of dollars per year. In short, the intended policy is simple, but its implementation is wildly complex.
CMS Estimates of the Cost of Compliance
As required by law, the government must estimate the impact of new regulations. Some examples of the impact this regulation will have on healthcare entities are below. Understand that these are CMS estimates, not those of industry, so they may well underestimate the actual costs of compliance. According to CMS, the Sunshine proposed rule will:
- Cost manufacturers collectively $195 million in the first year and $148 million each year thereafter.
- Cost physicians $24,000 per year to monitor and review the required reports in the first year, and $13,000 each year thereafter.
- Cost the federal government, on average, $183 million per year to administer the program. (There is no estimate provided for cost of possible additional state disclosure requirements allowed under the provision.)
- Potentially add to CMS coffers funds from civil monetary penalties (CMPs) derived from prosecuting those who do not follow the fine print of the regulation. However, CMS provides no estimate on the expected revenue from CMPs.
Practical Impact
There also are a number of practical implications that will result from the proposed rule, including:
- In certified CME programs, CMS would required providers of education supported by industry to report the value of the education provided for each attendee. Under current CME accreditation rules, company sponsors do not know who the attendees are and do not compute an economic value of the program for attendees.
- For all other education and research activities sponsored by medicine companies, the industry will now be required to value and report on each event. This will undoubtedly have a chilling effect on the number of physicians willing to participate in any sort of company-sponsored information exchange. While this may be the objective of many of the rule’s supporters, it could well wind up hurting patients.
- For the communications industry, there is the potential of significant additional burdens, many of which are unforeseen at this point.
Although the overall cost of this regulation is just a drop in the bucket in relation to the entire cost of delivering healthcare in the United States, this rule stands out like a sore thumb. While Congress is attempting to reduce costs, this new program adds costs without demonstrating value.
Coalition Interest
Aside from the Coalition’s general concern as good citizens about government regulation strangling our country’s progress, the Coalition is primarily concerned that the Sunshine program will drive a wedge between the medicines industry and healthcare providers. Companies have both a right and a responsibility to enable providers to have the best available information on medicines. If providers avoid industry-provided education, it will inhibit this sharing of information.
In summary, the Coalition supports transparency and will support efforts to achieve it. But we believe that the regulations should be clear, reasonable, and no more complicated than necessary.
Action
As we have said many times, government is not a spectator sport. Federal law requires CMS and other agencies to provide opportunity for citizens to comment on proposed rules. Individuals and organizations wishing to comment on this regulation must do so by Feb. 17, 2012. The Coalition will be commenting and welcomes your suggestions on the specific topics that should be addressed. Members should also feel free to comment directly to CMS. If you need assistance, we will be delighted to provide it.
[Editor's note: Jack Angel can be reached at jeangel@cohealthcom.org or (203) 661-3314.]
Jan. 6, 2012 — This article, written by Coalition for Healthcare Communication Executive Director John Kamp, was featured in the Jan. 3, 2012, issue of Medical Marketing & Media.
Industry must step up and lead on off-label, online communications
by John Kamp
FDA ended 2011 by initiating two major public dockets on off-label marketing that may provide much of the regulatory clarity the industry has needed to engage responsibly and more aggressively in the age of the Internet. The first is a
draft guidance on company responses to unsolicited questions regarding the off-label uses of medicines. The second
responds to the Citizen Petition by several industry companies that seeks more clarity on several off-label matters. In it, FDA asks the public to respond to over a dozen questions on how best to regulate in this area.
Those expecting the Ten Commandments of off-label and social media will be severely disappointed. But these are important and useful documents. Every medical communications professional should immediately study the draft guidance and work with clients to put it to work to better inform doctors and patients. Consider, too, participating in the comments to the FDA by the Coalition for Healthcare Communication on both documents.
The draft guidance on responses to unsolicited requests for off-label information requires the most immediate attention because it clearly and definitely sets out the long-standing informal policies of the FDA on how to respond to off-label questions. But, while clear, the new guidance is anything but permissive. Peter Pitts provides a quick review of the most important details of the draft, plus offers ten “lessons” to be learned from the draft.
Without stating why, the FDA draft guidance instructs companies to only respond to unsolicited questions and then only in private to the individual making the request. In effect, the FDA draft guidance would ban all company responses to off-label questions in traditional and Internet-based public media. The guidance clearly delineates the difference between a solicited and an unsolicited request, and provides plenty of examples on how and how not to respond.
Because the guidance is clear and authoritative, it may enable many companies to more confidently provide data to doctors and patients. But, it’s a small step forward and much more still needs to be done. The draft guidance simply does not go far enough to foster optimum information dissemination by companies nor does it address the significant First Amendment issues highlighted by last year’s Supreme Court decision in IMS v. Sorrell.
The challenge for industry in 2012 will be to use this guidance aggressively and responsibly while working with the FDA to support much larger steps forward to advance the public health through improved communications. Indeed, as the FDA explicitly recognizes in the draft guidance, drug sponsors often have data and information critical to patient care that is available nowhere else. As Congress and the public increasingly look to government to provide better, more efficient care to America’s patients, FDA must encourage companies to make these data more freely available. For example, if one-to-one conversations are appropriate, why are public conversations banned? The Coalition is coordinating with industry partners to address these and other matters and to encourage FDA to enable increased information dissemination.
But, marketers must recognize that great, innovative marketing that improves health outcomes is mostly up to us. Government regulates ; industry innovates and educates. We must be responsible and bold to reassure our most important customers — doctors and patients — that we are critical partners in patient care. Indeed, FDA needs our leadership to give it the confidence and political cover it requires to reform its most restrictive policies.
That’s why the Coalition for Healthcare Communication is working closely with the leaders of the Digital Health Coalition to create online good practice principles that will enable communication to support patient care while complying with FDA regulations. That’s why both coalitions look to companies and their marketing partners to continue to provide innovative and effective communication. And, that’s why we seek your input to our comments to FDA.
I’m optimistic that these two FDA announcements are just the beginning of a new, more proactive FDA in this area in 2012. An active FDA combined with aggressive leadership by regulated companies, agencies and media could mark 2012 as the year patients and doctors have better access to information that improves patient care.
Let’s all work together to make it happen. Doing so will require hard work, creativity, coordination and leadership, both in the marketplace and at FDA.
John Kamp is executive director of the Coalition for Healthcare Communication
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