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.
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.
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.
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 email@example.com 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
Jan. 6, 2011 – As the pharmaceutical industry begins 2012, the FDA’s Office of Prescription Drug Promotion (OPDP) recommends that companies focus their efforts on many of the common problem areas faced by their competitors in the last quarter of 2011, according to OPDP Regulatory Counsel Julie Chronis.
When asked by the Coalition for Healthcare Communication what advice OPDP might have for industry in the new year, Chronis, speaking at a Dec. 19, 2011, OPDP Webinar on Q4 enforcement actions, said: “I’ve got two words for you: Voluntary Compliance.”
“We are not off on a witch hunt, but are looking for companies to do the right thing,” she said, while suggesting that companies should both “look at our enforcement actions, guidance and regulations, which are “resources companies can use to assist them in their voluntary compliance,” and submit materials for advisory comments.
The OPDP issued eight Untitled Letters and no Warning Letters during this time period. The Untitled Letters cited a variety of alleged violations, as follows:
- Omitting or minimizing risk information
- Making unsubstantiated claims, including unsubstantiated superiority claims
- Overstating the efficacy of the products
- Omitting material facts
- Failing to communicate the indication in an adequate manner
- Promoting unapproved uses
- Inappropriate reminder labeling
- Presenting misleading claims
- Inadequate presentation of the established name
Although there were no particular trends noted in these enforcement actions, OPDP Regulatory Counsel Bryant Godfrey stated that OPDP “consistently sees the same types of violations, including omission of risk information, failure to communicate the indication, overstatement of efficacy and omission of material fact. These are some of the violations we see time and time again.”
Indeed, a number of questions posed to the speakers centered on when and how to provide risk information. An Oct. 25, 2011, Untitled Letter to Lantheus Medical Imaging for its TECHNELITE product states that an exhibit panel “makes several efficacy claims for Technelite, but omits material risk information for the drug” and in so doing, “misleadingly suggests that Technelite is safer that has been demonstrated by substantial evidence or substantial clinical experience.”
One Webinar participant asked why it was necessary to include all of the risk information mentioned in the enforcement action when the exhibit panel had so few claims. “The type of risk information is going to be very specific to that drug and the drugs in that class,” explained Chronis. “We are always going to want to see the most serious risks, along with the most commonly occurring risks. So, we refer you to the draft guidance that’s available on our Web site to give you more information on which risks we are going to want to see,” she said.
Another participant inquired why the firm including the phrase, “Please see a representative in this booth for full Prescribing Information,” was not a sufficient way of providing safety and risk information.
“There are a variety of reasons,” Chronis stated. “One, it’s entirely possible that the sales rep would leave the booth and not be available to talk to the people who stop by. Also, there are people who walk by and do not have the time or opportunity to speak to that rep,” she continued. “We would like to see risk information more accessible than just being available through one person in one specific place.”
When asked about the general success of the Bad Ad program in leading to enforcement actions, Voyard said that “doctors really seem to understand what we consider a violation and give us some very pointed complaints and accounts of what they’ve seen. In my view, I think it’s been working.” Chronis remarked that OPDP will continue to promote the Bad Ad program in 2012, and will begin holding CME events “to further educate health care professionals about the program and the work we do.”
The Webinar’s moderator, Sangeeta Vaswani-Chatterjee, OPDP regulatory counsel team leader, indicated that the agency has received positive feedback on the quarterly enforcement Webinars and plans to continue holding them in the future.
Jan. 2, 2012 – In the waning days of 2011, the FDA released a significant draft guidance on company responses to unsolicited requests for off-label information by healthcare professionals and consumers. Although the FDA explicitly recognized the value of company-provided information, the draft guidance adhered to its traditional policy stance strickly limiting such answers to the individual making the request and precluding public dissemination.
In effect, the FDA banned all public responses to off-label questions in traditional and Internet-based media where the company has any control of content.
“The FDA guidance is clear and authoritative, so will enable more and better communication with professionals and patients. Indeed, it may clear the way for many companies to more confidently provide data to doctors and patients. It’s required New Year reading for agencies, publishers and media intent on helping companies provide better access to life-saving data. ” said John Kamp, Executive Director of the Coalition for Healthcare Communication.
“It’s a small step forward that enables companies to more aggressively inform doctors and patients, but much still needs to be done. The draft guidance simply does not go far enough to foster optimum information dissemination or to address the significant First Amendment issues highlighted by last year’s Supreme Court decision in IMS v. Sorrell,” Kamp said.
“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,” he continued. “The Coalition is coordinating with industry partners to respond to this draft guidance and other comments to encourage FDA to enable improved improved information dissemination to healthcare professionals and the public.”
Draft Guidance Basics
The FDA’s Draft Guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” was issued Dec. 27, 2011. The draft begins by describing FDA’s legal framework for restrictioning off-label speech, but quicly acknowledges that “these off-label uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care.”
In light of the growth of the Internet as a significant source of information for patients and healthcare professionals, the FDA’s draft guidance was developed for firms “wishing to respond to unsolicited requests for off-label information, including both requests made directly and privately to firms and requests made in public forums, including through emerging electronic media.”
In the draft guidance, the FDA describes the difference between unsolicited and solicited requests for information and breaks down its recommendations into two sections – one for non-public unsolicited requests and one for public unsolicited requests.
Unsolicited Non-public Requests
In the non-public request section, the agency makes seven recommendations about responding to unsolicited requests:
(1) The response should be provided only to the individual making the request “as a private, one-on-one communication.”
(2) Response information should “be tailored to answer only the specific question(s) asked.” The agency states that if the request is broad, it is the company’s responsibility to “appropriately narrow the question.”
(3) Response information should “be truthful, non-misleading, accurate, and balanced.”
(4) Response information should “be scientific in nature” and not be “promotional in tone or presentation” or be distributed along with any promotional material or information.
(5) Response information should be generated “by medical or scientific personnel independent from sales or marketing departments.” The agency further recommends that sales and marketing personnel have “no input on the content of responses to unsolicited questions or requests for off-label information.”
(6) Response information should be accompanied by a copy of FDA-required labeling, a prominent statement notifying the response recipient that that FDA has not approved or cleared the product for the off-label use(s), a prominent statement disclosing the approved or cleared indications for the product, a prominent statement providing all safety information and any boxed warnings, and a complete list of references for all of the information disseminated in the response.
(7) Firms are directed to maintain records regarding the nature of the information requests (e.g., name, address and affiliation of requestor), the information provided to the requestor and any follow-up inquiries or questions from the requestor.
Unsolicited Public Requests
Responding to unsolicited public requests for off-label information calls for a different approach, according to the agency, which has concerns that “firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information … to individuals who have not requested such information.” Additionally, the FDA has concerns “about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated.”
Accordingly the agency recommends that firms respond only when the request pertains specifically to its own named product, that the response be limited to providing the firm’s contact information and not include any off-label information, that representatives who provide public responses clearly disclose their involvement with a particular firm, and that public responses not be promotional in nature or tone.
Firms also are advised in the draft guidance to include a mechanism for providing current FDA-required labeling, to not include any promotional material or links to any other information, such as product Web sites, product promotional Web sites, firm Web sites or third-party Web sites, and that the Web address where viewers are directed to obtain product labeling information itself not be promotional (e.g., www.bestcancercure.com).
The agency states that if a company follows the recommendations in the draft guidance for responding to unsolicited requests, “FDA does not intend to use such responses as evidence of the firm’s intent that the product be used for an unapproved or uncleared use.” The FDA further states that alternative approaches outside of these recommendations “would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use.”
Comments and suggestion on the draft guidance should be submitted within 90 days of the guidance issue date.