Commentary by John Kamp, Coalition Executive Director
Oct. 8, 2012 – Health and election news last week featured Coalition for Healthcare Communication fall meeting speakers Jennifer Duffy, J. D. Kleinke and Dr. Kavita Patel, as Romney breathed new life into his campaign and commentators questioned Obama’s focus and performance in Wednesday’s debate.
While we still have a few solid weeks to go before Election Day, we’re seeing more and more clarity on the future of healthcare changes under both parties. That is: No matter who wins, more Americans will be covered, the system will be delivered by a combination of public and private businesses, and every provider will face competitive and price pressures.
Sept. 30 op-ed piece in The New York Times Sunday Review, J.D. repeated much of the commentary he shared with us at our meeting (to view the op-ed, go to: http://www.nytimes.com/2012/09/30/opinion/sunday/why-obamacare-is-a-conservatives-dream.html?pagewanted=all&_r=0. Among many interesting points, he noted that the Obama health plan incorporated many Republican ideas and that it is not so different from Romneycare in Massachusetts. In the debate, while repeating his intent to repeal Obamacare on his first day as President, Romney himself just as quickly noted that several popular and private business-friendly provisions would be retained. After hearing Romney’s exceptions, few, other than J.D.’s readers and listeners, seem to ask just what WOULD be repealed.
But, much like the agreement of Patel and Kleinke at our meeting, both candidates repeated one clear message: healthcare costs must be squeezed from every provider or the system will bankrupt the federal treasury.
Meanwhile, throughout the week, many media outlets relied on Kavita Patel’s comments for expertise on Obamacare. The Cook Report’s Duffy told me Friday that the Presidential race still is too close to call, but that a different Obama is sure to show up in the next two debates. For more election insight, see the Cook Report article that nearly looks past the Presidential election and focuses on
Jennifer’s analysis of the Senate (http://www.nationaljournal.com/columns/cook-report/the-cook-report-romney-breaks-his-losing-streak-20121004). There, too, Jennifer says the majority is too close to call.
Cutting through all the media chatter, it’s clear that Romney met Charlie Cook’s pre-debate challenge to keep the race competitive and thus prevent the diversion of critical media advertising money from the top of the ticket to the hotly contested Senate and House races (http://www.nationaljournal.com/columns/cook-report/the-cook-report-shades-of-1996-20120927). Romney remains relevant and likely created enough momentum to keep the race interesting, keep the wags wagging and keep the media dollars flowing into the battleground states.
This week, we’ll see post-debate polling data that undoubtedly will mean more to the outcome of the election than the Vice Presidential candidates’ debate performance. Watch most closely the data on the dwindling number of undecided voters in the battleground states, particularly Florida, Nevada, Ohio, Virginia and Wisconsin – where Obama’s lead recently looked formidable.
Commentators clearly agree that Romney won big last Wednesday. To me, using tactics comparable to his favorite game of basketball, Obama was playing for the full season victory, still weeks away, perhaps looking past that night’s game. Romney took several three point shots and many counted. Meanwhile, Obama did not look in control of the ball. If Romney critically shaved Obama’s lead, it will take much more aggressive and effective play on the part of the President to avoid an upset.
While we’re now late in the fourth quarter, this game is far from over. Expect more aggressive shots and sharper offense from both parties – and an avalanche of marketing spin. Still, the most important political fact is that Romney needs several more baskets than the President to win this election.
As always, stay tuned.
2012 — Regardless of the outcome of the upcoming presidential election or the changing state of healthcare reform, “the patient is the trend of the future,” according to Kavita Patel, M.D., managing director, Engelberg Center for H
h Care Reform Fellow, Economic Studies, Brookings Institution. “Understanding the patient better, understanding [care] from a consumer’s perspective, is really important,” she told Coalition for Healthcare Communication members at the Coalition’s fall meeting, held Sept. 19 in Washington, D.C.
Patel, who discussed the goals of the Affordable Care Act (ACA) and identified areas that still need fixing (e.g., reimbursement, care delivery, quality measurement), said that there are several ways pharma and healthcare communicators can better support patients. “Consumer-facing products are a hot, hot, hot trend,” she said. “It doesn’t matter if you are a red state or a blue state. In 2014, health insurance exchanges are going up around the country.” When these exchanges are established, entities that help consumers navigate the uncertainty will be viewed favorably.
“Whoever can emerge as a trusted voice or figure – be it a pharmaceutical company, a hospital, an insurance company or a social media company – that role is going to be not only where the money is, but what sets apart winners and losers in this new era of healthcare,” Patel said.
Healthcare communications also should focus on value, she advised. “Messaging which conveys a signal about value” is key to showing consumers why certain products are “worth the extra dollars.” Patel recommended that pharma companies reconsider their direct-to-consumer ads, because they may focus on attributes that either are not significant to consumers or are not understood by consumers. For example, she mentioned seeing a television ad that she thought contained details about the percentage of a drug but did not include sufficient background information.
“I was thinking that [the company] has a lot of faith that the average consumer is going to understand that this [percentage] means something and that it’s higher than the standard product that had been offered,” she said. “That’s where people are trying
to experiment with messages that demonstrate value, contrast and why it is worth the extra dollars for a certain product.”
Patel also noted that companies can help to shape the new healthcare lexicon – from accountable care organizations (ACOs) to health insurances exchanges (HIXs) and health information exchanges (HIEs) – which can be confusing. She added that “there is a tremendous need for smart, savvy communications about how we talk about products and how we talk to consumers.”
J.D. Kleinke, medical economist and author, American Enterprise Institute, told the Coalition that the next wave in healthcare communication is “context.”
“We need to have a much richer understanding about how drugs work and who they work for,” moving away from a product focus and toward a better treatment fit and stick rate, Kleinke said.
“When an industry is mature, it needs to move from product innovation to process innovation,” he noted, advising Coalition members to focus on “finding the right patients, helping to ensure that patients fill prescriptions and continue to stay on their medications. This is where you will find better value and margins for drugs.”
Part of this approach includes providing access to consumers about their conditions and available treatments. “The more access people have to data about their condition, the more willing they are to try something,” Kleinke said.
Coalition for Healthcare Communication Executive Director John Kamp told attendees that the onus is on industry to do its part. “The pressure is on us and our clients to reduce costs and minimize marketing sins,” Kamp said. As healthcare changes and challenges increase, “we just have to do our jobs better and more effectively.”
Aug. 21, 2012 – A recent article posted on Pharmalot.com suggests that pharmaceutical company direct-to-consumer (DTC) spending tells a story about the company’s product
For example, the article states that data released by Cegedim Strategic Data – charting DTC spend by the top 10 pharma companies from July 2011 to April 2012 – demonstrate that Pfizer “boosted its [DTC] spending considerably in the weeks leading to the patent expiration for its best-selling Lipitor cholesterol pill and then, overall, curtailed that spending in subsequent months.”
According to the article, the company spending the most money on DTC advertising during this period was Eli Lilly. “This likely reflects, in part, a need to keep its corporate head above water in the competitive diabetes market,” the Pharmalot article states.
“It is important to watch these developments on DTC measured media, but we need to recognize that they are just estimates, and only estimates of some consumer outreach,” remarked Coalition for Healthcare Communication Executive Director John Kamp. “Moreover, they don’t present a full picture of marketing spend and miss many emerging consumer media.”
Mark Tosh, managing editor, BTP Insights, agreed that reported DTC spending totals do represent a way to gauge the broader DTC advertising market across a period of time, but he told the Coalition that “the numbers should not be viewed as the absolute measure of spending by an individual company or brand.”
Tosh noted that print and even broadcast advertising space is discounted from the rate card, and “there really is no way to accurately calculate these discounts or to know which company (or whose media agency) drives the hardest bargain at the negotiating table.”
Also, there is an area of DTC spending – point-of-care marketing – that passes “mostly under the radar,” he
said. This marketing includes an array of materials available at doctors’ offices and pharmacies, and is a growing segment of the market, according to Tosh.
“So, while it’s interesting to get the ‘best guess’ total on the overall DTC sector, the numbers are likely far from the actual spending reality that companies report internally,” he said.
To read the full Pharmalot article, go to: http://www.pharmalot.com/2012/08/which-drugmaker-spends-how-much-on-dtc/
Aug. 20, 2012 – With the politics of healthcare front and center during the final days leading up to the
2012 Presidential election, the Coalition for Healthcare Communication’s Fall Member Meeting, to be held Sept. 18-19 in Washington, D.C., will feature speakers who know which candidates are running ahead and how they might change the Affordable Care
Act and other health policies once they are in office.
Jennifer Duffy, senior editor of the Cook Report, will kick off the meeting with an election preview, and two veteran health policy advisors – J.D. Kleinke from the American Enterprise Institute and Dr. Kavita Patel from the Brookings Institute – will discuss the future of Washington-directed healthcare programs. Highlights from the Coalition’s meeting will be included in future postings on the Coalition Web site.
For more information on how to join the Coalition, please contact Coalition Executive Director John Kamp at firstname.lastname@example.org.
July 23, 2012 –Michael Sauers, team leader (DTC1) at the FDA’s Office of Prescription Drug Promotion (OPDP), held a workshop at the DIA 2012 Annual Meeting that walked attendees through actual examples of where promotional materials for pharmaceutical products fell short of meeting FDA requirements.
During this interactive DIA workshop, “Prescription Drug Marketing Regulatory Primer,” held June 27 in Philadelphia, Sauers provided some basic tenets of prescription drug promotion regulation and then led the audience through a sampling of promotional pieces that the agency found to have violated the regulations.
For example, in describing omission of risk information – a violation commonly cited in OPDP Warning Letters and Untitled Letters – Sauers showed DIA session attendees a promotional flyer for ISTA Pharmaceuticals’ BROMDAY, which was cited in a July 13, 2011, Warning Letter. Although the flyer making claims regarding the use of Bromday in cataract surgery discloses the most common adverse reactions associated with that use, it does not reveal any of the warnings and precautions for the drug.
Promotional materials that make product claims must also provide risk information, according to Sauers, who noted that this risk information should include contraindications, warnings, precautions and pertinent adverse events. Further,
even though the Bromday flyer included the statement, “Please see full prescribing information on reverse,” that reference does not fulfill regulatory requirements, Sauers explained.
In discussing problems with the presentation of risk information, he presented a stall cling for GELNIQUE – cited in a Nov. 30, 2010, Untitled Letter to Watson Pharmaceuticals Inc. – to demonstrate that formatting factors, including the shape, size and general layout of presentations in a piece, are important in achieving adequate risk presentation. The Untitled Letter cited the company for relegating the risk information “to the bottom of the piece and written in white text on a purple background in an extremely small font size and in single-spaced paragraph format, making this information very difficult to read.” In describing how risk information should be adequately conveyed, Sauers also indicated that framing and sequence are important.
Sauers made it clear in his presentation that oral statements not made in response to a request for such information from a physician can be problematic if they discuss unapproved uses. For example, he cited oral statements made by a physician on behalf of Merck & Co. Inc. regarding the company’s SAPHRIS at a lunch presentation. Saphris is approved for schizophrenia and bipolar disorder, but the speaker stated that he prescribes the drug as an adjunctive treatment for major depressive disorder (MDD) and that it works just as well.
Promotional materials should not suggest that a drug is safe and effective for conditions or patient populations that it is not approved to treat, according to Sauers, nor should they suggest that a drug treats outcomes or consequences of a disease if the drug has not demonstrated such an effect on those outcomes or consequences. He added that claims of superiority generally must be supported by adequate and well-controlled head-to-head comparative studies.
Further, claims about efficacy and safety in promotional materials must be consistent with the PI and be supported by substantial evidence derived from adequate and well-controlled studies, Sauers asserted. To illustrate the substantial evidence requirement, Sauers showed attendees a Noven Pharmaceuticals Inc. flash card for PEXEVA.
This marketing piece, cited in a May 24, 2011, Untitled Letter, misleadingly implies that Pexeva is effective in treating patients with co-morbid MDD and generalized anxiety disorder (GAD), when this has not been demonstrated by substantial evidence or substantial clinical experience, the Untitled Letter states: “While Pexeva is indicated to treat MDD and GAD individually, no clinical studies demonstrated efficacy
of Pexeva in treating patients experiencing these two conditions concurrently.”
Overstatement of efficacy – often conveyed through testimonials or imagery – also is a violation that is commonly cited by OPDP. Sauers’ presentation made it clear that patient testimonials and individual case studies may be an accurate reflection of one patient’s experience, but that alone does not constitute substantial evidence.
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 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
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.
Dec. 14, 2011 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be presenting a Webinar next week to review the enforcement actions it took during this quarter. The Enforcement Webinar – the third the agency has hosted this year – will be held on Dec. 19, 2011, from 2:30 p.m. to 3:00 p.m. (ET). Viewers can begin submitting questions 30 minutes prior to the Webinar start time.
These Webinars are offered under a pilot program “in which OPDP will give our stakeholders a chance to directly communicate with the Agency on clarifications or questions about the Warning Letters and Untitled Letters issued by OPDP in a given quarter.” The Dec. 19 Webinar will cover Warning Letters and Untitled Letters issued from September 2011 to December 2011.
The Webinars are part of a pilot program that is intended to “support OPDP’s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
Meeting details provided by the agency are listed below:
To join the meeting:
Conference Number(s): 301-796-2700
Participant Code: 252580
If you have never attended a Connect Pro meeting before:
Test your connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
Get a quick overview: http://www.adobe.com/go/connectpro_overview