If you are an Rx regional sales director or a product marketing manager, I have a somewhat provocative question for you:  How exactly are you planning your 2014 Medicaid strategy?

I ask this because as you look over the Medicaid landscape for next year, there is more than a little uncertainty at hand.  With Medicaid about to become the basic health care delivery mechanism of the 2010 Affordable Care Act, otherwise known as Obamacare, you would think this might be a simple matter of reviewing the new federal law for guidance. But if that’s the approach you are taking for your 2014 Medicaid planning, let me be the first to tell you, you are going down the wrong path.

Obamacare is premised on the idea that federal government and state governments will cooperate in the delivery of healthcare to an estimated 40 million new Medicaid patients starting on January 1, 2014, with sign up for these new services scheduled to begin on October 1, 2013.

That is all well and good, so far as a reading of the law goes.  But when you begin to dig into how the states are actually implementing Obamacare, you soon realize the launch of this new law is not going as smoothly as the framers of the measure had hoped.

As of this writing, and according to the Kaiser Family Foundation, there are 26 states that have said absolutely “no” to state exchanges envisioned by Obamacare and are defaulting to a federal exchange; 7 that have said “no” to parts of Obamacare and have negotiated “Partnership Exchanges” with HHS; and only 18 that have declared they will establish state-based exchanges, and cooperate with new law.

If Kaiser is correct in these assessments and given the current US population of about 313 million, this means that approximately 56% (177 million) of Americans live in states that have said effectively said “no” to Obamacare; 10% (32 million) live in states that have rejected parts of Obamacare; and only 33% (104 million) live in states that will have access to Obamacare’s state exchange offerings.

If these statistics startle you, they should.  Thinking about your 2014 “numbers,” how will you manage this situation nationally?  In particular, what will happen in those states that are “defaulting to the federal exchange?”  Here are two key examples you may want to focus on for your answers.

Florida

Florida’s current population is about 19 million.  Right now, 3.3 million Floridians (approx. 17% of the state) are enrolled in FL Medicaid.  It’s estimated that another 1.3 million Medicaid recipients will be added to Florida’s Medicaid rolls once Obamacare is implemented.  This creates a potential situation in which nearly 25% of Florida’s total population is scheduled to be receiving Medicaid Rx care after January 1.  Any Rx sales manager or product marketer who is responsible for the State of Florida has to take notice of these numbers.

So how is the implementation of Obamacare going in Florida?

This past winter, Florida’s governor, Rick Scott, a Republican, publicly broke ranks with his Republican Governor Association colleagues, and announced that he was seeking a “deal” for Florida that would accept the essence of Obamacare, i.e., the federal financial support, while adopting a 100% federal provision of insurance services, all of which sunset and be reviewed after three years.

Seemed like a done deal. But when Gov. Scott took his concept to the Florida legislature, he encountered stubborn resistance from the Florida House of Representatives.  In the end, the governor gave up and the entire Obamacare package was shelved. Florida, it appears, will default to whatever the “federal exchange” may turn out to be.

So, how as a sales & marketing executive with responsibility for Florida do you plan your sales and/or marketing strategy in this huge, heavily Medicaid impacted state?  What drugs will be covered in the “federal exchange?” Will only one drug per category be covered, per the earlier recommendations of the Essential Health Benefits finding put out by HHS? How will you get your drug covered for Florida Medicaid in 2014? How will you get reimbursed? From the state or the feds? And at what rate? Right now, nobody knows the answers to any of these questions.

Let’s look at another important example that is being impacted by Obamacare: Texas.

Texas

Texas is now the number two most populous state in the nation with an estimated 2012 population of over 26 million. It’s also one of the fastest growing states in the nation.  Given all of this, I don’t think it would be an overstatement to suggest that every Rx sales and marketing director in the country wants a piece of Texas.

So let’s consider the impact of Obamacare’s implementation here. Currently, Texas Medicaid beneficiaries number approximately 5 million individuals, or about 20% of the population. An estimated 2.6 million beneficiaries could be added to the Texas Medicaid rolls under Obamacare. That would total 7.6 million people, or about 29% of the State of Texas population.

Unlike Florida, however, Texas has been a steadfast “no” in cooperating with the federal government on the implementation of Obamacare from the start. Therefore, Texas had no debate about setting up a state exchange for new Medicaid patients. Instead, like Florida, a new federal exchange is supposed to be put into operation for nearly 8 million Texans by January 1, 2014.  How this will be accomplished in Austin is unclear at this time.

Again, as regional sales directors or product managers for Texas, how do you plan on “making your numbers” in this huge market for 2014?

Planning Elements for Medicaid Sales & Marketing in 2014

I could go on from here with the specifics of each “no” state, but I think you get the picture.  Just Florida and Texas, alone, both among America’s most populous states, account for nearly 10% of the estimated 40 million total Medicaid expansion this new law is supposed drive come January 1, 2014.  These two states by themselves stand to generate massive Rx sales that will impact anyone’s national sales or product marketing plan.  However, both are essentially blank pages today in terms of how your products will be included on a formulary, what the reimbursement rates will be, who will pay you for their dispensing, and all the rest that goes into making money in a state Medicaid Rx program.

And the same is true for the other 24 “no” states. Nobody has answers. Overall, you are essentially in the dark as to how to plan for about 22 million new beneficiaries with drug coverage.

So how do you to manage your sales and marketing for Medicaid Rx patients in this 2014 environment?

First, you are going to need much better intelligence on what every state has decided to do with its Medicaid Rx program than you have ever had before.  Given 40 million new potential, paying customers, you would be foolish not to demand the best, most complete information available on each state.  If you don’t have that deep info, frankly, how can you establish sales and marketing goals for 2014?

Second, you will need to figure out how each state will actually administer Obamacare. Will it be by default to the federal exchange; the negotiated “partnership exchanges;” or through separate state exchanges? And depending on which policy the state has chosen to follow, what will that mean to you? Every state will do it differently based on their medical culture, the state’s finances, and the level of cooperation medical providers offer in each state. Understanding all of these factors will be imperative.

Third, I would suggest this situation is anything but static (some states may quickly walk away from Obamacare after it starts; others may decide to join; still more could come up with entirely unexpected solutions for their populations).  You will want onsite staff in many of the major state capitols just to keep track of all of this. That could be expensive, but how else are you going to stay on top of all of these developments?

In short, sales and marketing execs are going to have to think way outside of the box in 2014 if they believe their Rx company will enjoy the financial benefits of Obamacare’s new Rx coverage.  And this is certainly not to say that the prospects for monetary gain don’t exist. They clearly do, but only if you can figure out how to convert on this Obamacare opportunity in each state.

All of this said, I believe this particular reimbursement opportunity will be unlike any other the US drug industry has ever faced. The reimbursement uncertainly, intrusive politics, and the shear market chaos that is likely to result will be challenging. But it’s also equally clear that if you stand around, waiting to see “how things develop” under Obamacare, you run the risk of substantial Rx sales and marketing losses for 2014, and beyond.

The choice is clear. You have to engage, come what may. So, what’s your Medicaid Sales and Marketing plan look like for 2014?

Tom Norton is principal at NHD Smart Communications. He can be reached at tnorton@nhdcomm.com

At the beginning of the Reboot Camp – held at New York City’s Alexandria Center on April 12 – Intouch Solutions’ CEO Faruk Capan declared the days of Don Draper effectively over. The route to patients’ hearts and minds isn’t Old Fashioned cocktails and intuition; it’s solutions based on patient, provider and payer needs, and making disparate data streams pool around brand objectives.

Katherine Patterson, global marketing communications manager, growth initiatives, GE Healthcare

Katherine Patterson, global marketing communications manager, growth initiatives, at GE Healthcare, gave the keynote address, which focused on clarity of mission in marketing execution, and the importance of marrying science and emotion for consumers. Marketers too obsessed with social media, or the newest digital platform, might impress only themselves. “It’s like peeing down your leg…hot to you, but nobody else,” said Patterson. In Japan, for example, GE Healthcare’s medical device customers “are moving back toward print” as a preferred marketing channel, although growth markets “want digital,” and they want it on their mobile devices, she said.

Citing Eric Topol, currently director of the Scripps Translational Science Institute, Ben Chodor, CEO at Happtique, said we’re not too far away from a time when physicians prescribe more apps than pharmaceutical drugs. Chodor is betting on Topol’s prediction; Happtique, a mobile health application store, will “curate” mobile apps for docs through a private, customized dashboard of Happtique-certified health apps. The company’s patent-pending software would allow physicians to electronically prescribe apps to patients. Chodor says he’s lobbying the SEC to reimburse medical apps, noting that some private plans already do.

Happtique doesn’t make apps itself, but Chodor appeared before the US House of Representatives’ Energy and Commerce Subcommittee on Communications and Technology in March to support FDA’s regulation and definition of mobile medical apps. “It’s relatively simple to take an app through FDA” [for a medical device designation], and it only costs between $10,000 and $20,000, he said, noting that 75 mobile devices/apps have already been approved. Chodor said the Affordable Care Act’s medical device excise tax – “the absolute worst tax ever” – should not be levied on smartphones or apps.

Asaf Evenhaim, co-founder and CEO of Crossix, reminded Reboot Camp attendees about the unfathomable amount of individual consumer or patient data that exists for marketers, while insisting on the importance of privacy and HIPAA regulations. His company collects this data to create “propensity scores,” which serve as the basis for highly specific predictive models. The models can then be used to predict healthcare purchase decisions.

Where does all that data come from? Some of it is volunteered, some is collected invisibly through cookies, Facebook and other online aggregators, and some of it – but not Crossix’s data – is gleaned from trolling social media channels and blogs. Passive data collection, said Intouch Solutions’ senior vice president David Windhausen, is revolutionizing pharma marketing and health itself. Windhausen said he looks at his Nike FuelBand in the evening, and if he hasn’t been active enough, it’s time to exercise.

Windhausen’s talk lovingly described the Sanofi mobile app “GoMeals,” an app for diabetics specifically, but also for anyone who wants on-the-go nutritional facts about nearby restaurants (among other things). An attendee representing Sanofi – which is an Intouch client – let slip that GoMeals, and possibly the iBGStar glucose meter, would start to integrate passive data from wearable tracker gadgets like Fitbit or the FuelBand as early as this year.

Capping off the Reboot meeting was Augustin Fou, founder and chief digital strategist, Marketing Science Consulting Group. Fou emphasized the importance of recognizing how patients’ habits, expectations, and actions – in the context of healthcare – have changed, and how they continue to change. He referenced a Capgemini Consulting report on “digital maturity” that placed pharma at the very bottom of the list.

Despite regulatory hurdles and because of an explosion in mobile technology, data capture, and the influence patient’s have on the delivery of healthcare, pharma marketers could use a reboot. But they’ll need to back-up some of the dusty old tropes of yesteryear, even those that precede Don Draper. As GE Healthcare’s Patterson noted, Aristotelian rhetoric, comprised of ethos, pathos and logos – in equal measure – works as well in a sales detail as it did in symposia. The occasional Old Fashioned might be okay, too.

Conducted across 46 states and with a group of 400 respondents, the sample was representative of just how many nurse practitioners, physician’s assistants, clinical nurse specialists and certified nurse midwives there are in the US. The demand for NPPs is leading to higher pay and an increased respect within the payer community. Aetna now considers nurse practitioners, for example, to be primary care providers and reimburses them for their services thusly.

When considering what influenced their behavior as prescribers the most, the survey found that NPPs tend to consider efficacy, their experiences with the drug, and price, in that order. As 82% of the respondents indicated they had no restrictions when dealing with sales representatives (17% had certain restrictions, and 11% said they were completely restricted), and that most respondents were open to support from them, why have sales reps and pharma by and large neglected to address this demographic?

Brenda Rizzo, author of the report and an advanced practice nurse herself, says sales reps make calls “based upon prescribing behaviors, and on that basis alone, NPPs are pretty much invisible.” Misconceptions about NPPs abound, according to the report, including that they prescribe based on a protocol set by their physician practice partners, that if they have the ability to prescribe, they rarely do, or that they are simply refilling prescriptions that have already been decided on by a physician. Pharma “doesn’t realize that this is an audience that makes independent prescribing decisions, and that having the right information to make those decisions is incumbent on pharma companies; to provide it to non-physician prescribers is equally important as it is to provide that information to physicians,” emphasizes Rizzo.

So what kind of information do non-physician prescribers want? As a group shown to be active attendees of national conferences and maintaining exchange of advice among colleagues and fellow professionals, first and foremost the information should be sharable and accurate to provide trustworthy resources that can further facilitate dialogue and be spread easily. Secondly, NPPs listed printed education materials from pharmaceutical companies as one of their top-rated tools when looking to improve patient compliance. More specifically, 61.3% of respondents, when asked about what kind of support they’d expect from pharma companies, said “Education about the pharmaceutical drug or medical device directed to the NPP for the patient,” 54.5% responded “Disease state information to educate the patient.” and 51.5% said “Assessment tools to help identify problems that can be addressed.”

NPPs, as this study shows, not only want to engage, but expect valuable engagement tools from pharma to help make their jobs easier. With primary care taking on a new definition that includes long-term, patient-focused care, the physician’s ability to orchestrate outcomes is increasingly being diluted and in need of help from nurse practitioners, physician’s assistants and other NPPs. As such, pharma needs to keep a keen eye on these providers: payers, private practices, and health care facilities have already gotten the memo.

To read the March cover story in the PharmExec digital edition, click here.

The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – from disease and drug-mechanism education to efficacy, safety and lifestyle claims – dovetail across the traditional physician-patient separation.

“We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions,” wrote Janet Woodcock, director of the Center for Drug Evaluation and Research, in an email on the changes. “The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising.”

Before it got upgraded to a “Super Office” in 2011, OPDP was fondly (or sometimes not so fondly) called DDMAC (dee dee mac), which stood for the Division of Drug Marketing, Advertising and Communications. When DDMAC turned into OPDP, the office was split into two divisions: the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion. As OPDP, the steady stream of warning and untitled letters continued unabated, mostly chastising pharma marketers for misbranding, off-label, overstating the efficacy or minimizing the risks of a product, or the misuse of a color scheme, in one famous educational piece created for Novartis.

With today’s announcement, ODPD, pending final review, will rename its two primary divisions. They will now be called the Division of Advertising and Promotion Review I, and the Division of Advertising and Promotion Review II. Review of promotional materials will be separated and organized by therapeutic class, not by professional or consumer. “ODPP concluded that a structure that integrates the review of health care professional-directed and consumer directed promotion across the two divisions” would meet the stated goals of increasing efficiency, improving work distribution, and eliminating redundancy, wrote Woodcock.

“Our ODPD reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers,” she wrote.

Tom Abrams remains head of ODPD. For a list of the new review groups categorized by therapeutic area, click here.

If a patient or physician encounters pharma-created content that doesn’t pop with relevance or utility, it doesn’t matter how multitudinous the channels are that carry it. There is no patience online for bad content.

Pharma has the resources to create, or hire someone to create, great content. But the problem is that great content lies in the eye of the content beholder. Complicating matters further, that single set of eyes may find certain content relevant or useful in one channel on one day, but may have different needs or expectations in another channel, next week. Digital marketers hope the answer to the problem of effective mass personalization – a term that reads like an oxymoron – is big data and better analytical tools for parsing it. If enough data is compiled about a given patient, for example, it follows that sophisticated, real-time analytics will be able to predictably advise brand managers on precisely what information a patient needs at any stage of her journey, in whichever channel she prefers.

Needless to say, that level of sophistication hasn’t yet occurred in the healthcare industry. Speakers at the ePharma Summit in New York this week appear hopeful that it will happen soon, but many acknowledged the organizational changes that need to happen first.

Continuous questing for new data streams can be a quixotic endeavor, leading to “analysis paralysis,” said Nancy Phelan, VP, customer strategy and operations at Bristol-Myers Squibb. Internally, pharma needs to “think differently about the talent and skill set” needed on the commercial side, and organizations must liberate digital marketing from fixed events like budget cycles and calendar-based points of action (POAs). Companies should institute “real-time processes and decision-making” for digital marketing execution, said Phelan.

On a mobile health panel, Sharon DeBacco, senior director, customer communications and operations at Ironwood Pharmaceuticals (and formerly an AstraZeneca consumer marketing leader and brand director on Nexium and Crestor), said “mobile is a marketer’s dream,” but it’s stuck on the fringes of healthcare, in wellness and fitness apps on the one hand, and in sensors and devices for critical care on the other. Missing is the middle ground patient and his chronic condition. From a content management standpoint, mobile can be “challenging and confusing,” acknowledged Scott Wolf, EVP, sales, at Everyday Health. DeBacco said the challenge for mobile is how to combine the many transactional activities phones and tablets are typically used for, to develop first a greater understanding and then a unified program for consumers.

With regard to the future of professional promotion, “pharma needs to find its way back into doctors’ lives,” said Jordan Safirstein, an interventional cardiologist. “Taking a doctor out to eat and giving them journal articles is antiquated…it doesn’t work.” Sales reps are less effective today because “physicians have no say anymore in what drugs are on the formulary,” said Kecia Gaither, vice chairman, department of Ob/Gyn, director of maternal fetal medicine, at Brooklyn’s Brookdale University Hospital and Medical Center. “That decision comes from the chief financial officer,” and to a lesser extent, the head of pharmacy, she said.

Asked about what pharma can provide to physicians, Safirstein said embedding reference texts within EMRs is one opportunity. “The most common thing I see [in the hospital] is a resident walking down the hall, staring at a screen. Pharma must take advantage of this.” What about copay cards? “I’ve never heard a patient say, ‘Thank God you gave me that coupon card,’” said Safirstein, adding that the biggest innovation to the healthcare system in recent years was the launch of generic versions of Lipitor and Plavix.

Despite ongoing challenges in digital promotion on the consumer and professional side, 72% of the healthcare companies surveyed for a recent Best Practices report said they planned to increase their digital marketing budgets by more than 10% in the next two years. Even with additional resources, will pharma be able to craft relevant and useful messages for individual patients and physicians, and deliver them successfully? The best way to find out what questions a specific customer wants answered, right now, is to ask. The best way to meet that need is to provide an answer, fast. Whether big data, new technology and analytics can help pharma provide that kind of mass personalization – at an acceptable scale and in the context of strict regulatory controls – remains to be seen.

Speaking at the CBI Pharmaceutical Compliance Congress in Washington DC this week, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER), said that the government is not seeking further review of the Caronia decision, largely because the decision “does not find a conflict between the Act’s misbranding provisions and the First Amendment.”

In fact, the Court of Appeals decision didn’t challenge FDA’s contention that promoting a drug for unapproved uses may be evidence of misbranding. Thus, the Second Circuit ruling – which involved a divided panel, Abrams emphasized – “does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act.” After delivering his remarks on the Caronia case, Abrams told the audience that he would not take any questions on the subject. Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, noted during a separate CBI panel that shortly after Caronia, an off-label Amgen settlement went through the Second Circuit, the same court that found in favor of Caronia, without all of the First Amendment fanfare.

Here’s Abrams’ full statement:

The government has determined not to seek further review of the Second Circuit’s decision in United States v. Caronia, No. 09-5006-cr (2d Cir.).  FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&C Act).

In 2009, Alfred Caronia was convicted of conspiring to distribute a misbranded drug in violation of the FD&C Act.  A divided panel of the Second Circuit held that the jury instructions erroneously permitted, and that the government’s argument encouraged, the jury to treat speech promoting unapproved (off-label) uses of an FDA-approved drug as a criminal offense in and of itself.  The court of appeals did not address the constitutionality of the theory of liability on which the government had defended the conviction:  namely, that the promotion of a drug for an unapproved use may be relied on as evidence that the unapproved use is an intended one, and a drug that lacks adequate directions for its intended uses is misbranded.

Because the court did not address the constitutionality of a prosecution resting on that theory, and because the court also acknowledged that the First Amendment does not preclude an enforcement action based on speech regarding unapproved uses that is false or misleading, the Second Circuit’s decision does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act, including through criminal prosecution where appropriate, in cases involving off-label promotion.  More generally, the decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.

Abrams said that pharmaceutical promotional materials are “improving,” and that strong voluntary compliance by industry is critical for OPDP to be able to oversee some 80,000 promotional pieces a year. In general, pharma ads appear to be less violative, and of a higher quality, though some materials still present cause for concern, said Abrams. OPDP has “zero tolerance for misleading promotion,” he said. In response to a question from the audience on whether OPDP would tread lightly on a company if it voluntarily reported a promotional misstep or mistake, Abrams reiterated the need for voluntary compliance, and said OPDP would hardly ever take an action if a mistake is self-reported, and also corrected. Given the number of promotional materials OPDP is tasked with reviewing each year, the agency must set priorities, said Abrams. Those priorities include ads for newly approved products, drugs with significant risks and products subject to past violations and complaints.

With respect to policy and guidance documents for industry, Abrams once again stated that social media guidelines are among the agency’s “top priorities,” in addition to other areas of interest, including the use of health economic information in making formulary decisions, and the addition of comparative effectiveness claims in a drug’s label.

Additional reporting contributed by Ben Comer.

In the 12 month period to June 2012, Russia’s promotional spend increased 42% in comparison with the year before, followed by China with a 30% increase and Brazil with 22%. Commenting on the rising tide, Christopher Wooden, VP of Global Sales at Cegedim says, “In the last 18 months or so, these markets have leapfrogged some of the more conservative markets in Europe such as Spain and France in their use of digital.” This quick embrace of internet, mobile phones and even social media by physicians,  Wooden reports, is the result of laxer regulatory environments in emerging markets; by comparison, slower adopters in Europe are often simply suspicious of these platforms.

Nevertheless, markets across the board will see rises in digital spend, as digital channels are less costly in times where budgets are tight.  As Wooden points out, “the next generation of doctors just starting to practice are much more open to digital channels, because they’ve been exposed to it early on.” This trend, however, depends on how well drug companies adopt these technologies and integrate them into existing functions and organizational structures.  It remains a challenge to design and implement the tools in a seamless way.

The survey also points out that while digital spend is seeing an increase; companies are not necessarily scaling back on the more traditional methods of drug promotion. Sales representatives have a well-established share of the budget because physicians, who in a sense act as savvy consumers, want face-to-face interaction when weighing the decision to prescribe a new medicine. Spending has been diverted from more traditional channels not because they are less effective, but as a result of emergent technologies. So, in essence, pharma is still figuring out the perfect mix of channels, new and old, best suited to getting that brand noticed, in front of physicians.

As the New York Times’ Gardiner Harris has adeptly reported, newly-minted physicians emerging from their final rounds of a med school residency are much more likely to join up with an integrated delivery network (IDN) or chain of privately-owned clinics, than join or start a private practice. The reasons for this are numerous – private practices, for financial reasons, are being sold into aggregated networks, so basic job availability is one part of it – but importantly, lifestyle changes like the need to balance family responsibilities evenly between partners have made the prospect of working 60 or 80 hours a week to build up a private practice untenable, or at least undesirable, for many new doctors.

As a result, new cancer specialists (and many veteran oncologists) find themselves practicing medicine under the auspices of an authority higher than themselves, one with productivity measures and process requirements, in addition to policies around sales rep access. Even though 60% of oncologists say they prefer in-person visits with sales reps – 80% of community oncologists and 60% of academic oncologists say they continue to see reps on a daily or weekly basis – access is likely to continue getting squeezed, due to corporate policy or institutional mandate, according to The Complete Oncologist, a new report from MDLinx, an M3 company.

Physicians don’t like to be told how to practice medicine, and even if access to sales reps specifically isn’t what spurs a rebellion, “I think we are going to see these institution-based doctors begin to push back against the institution’s profit mandate,” says David Deutsch, global head of syndicated products at M3 Global Research. “One of the reasons [institutions] are restricting reps, in our estimation, is that it’s a time issue.” Managers at private clinics or institutions may feel that a physician ought to be seeing a patient instead of listening to a sales rep, says Deutsch. “It’s all about productivity measures in the larger IDNs, and particularly those practices that are owned by large chains that are not hospital-based, but are ‘industrial practices,’ as it were.”

While total sales rep headcounts across all therapeutic areas have slipped to around 70,000 or 75,000 – less than half of the roughly 150,000 reps working full time during the 2000 to 2005 heyday of professional sales – “fully 10 to 15%” of the current rep population represents oncology reps, a 50% increase over the last five years, says Deutsch. Pharma companies “believe they need to have more oncology reps to get more time with those doctors that they are still seeing,” says Deutsch.

When oncologists do go online, it’s probably not for a digital detail, and it’s almost definitely not for social media. According to findings in the report, 50% of the oncologists surveyed said they never use social media, and only 21% of community oncologists (and 10% of academic oncologists) said they visit online peer networks when seeking information about clinical decisions. Online, professional journals were the destination of choice for both community and academic oncologists, and communication with colleagues, in person, or by phone or email, was also cited as an important channel for clinical decision-making.

The Complete Oncologist is the result of surveys conducted with 385 oncologists. Almost half of them said they never visit pharma corporate or brand websites, and all of them see at least 100 patients per month, according to the report.

If a drug’s label is not the final word on what is true – or untrue – about a product, then who decides what can and cannot be said during a sales detail?

[To listen to the full oral arguments given at the 2^nd US Circuit Court of Appeals on December 2, 2010, which presaged the court's decision discussed below, click here.]

For as long as most of us can recall, without consulting the internet, the FDA has served as industry’s head arbiter of truth with respect to what can and cannot be said about a prescription drug’s safety and efficacy, at least in the US.

For pharmaceutical manufacturers selling products in the world’s largest drug market, if it’s not on the FDA-sanctioned drug label, it’s patently false or misleading, ipso facto. The 2^nd US Circuit Court of Appeals, in its decision on US v. Caronia, calls FDA’s authority to regulate “truthful” commercial speech into question under the First Amendment.

While the Food, Drug and Cosmetic Act (FDCA) does not expressly prohibit off-label promotion, “government has treated [off-label] promotional speech as more than merely evidence of a drug’s intended use – it has construed the FDCA to prohibit [off-label] promotional speech as misbranding itself,” wrote US Circuit Judge Denny Chin, a President Obama appointee to the appeals court, in the majority opinion.

Beyond discussing off-label drug uses with colleagues, physicians can prescribe any medication for any medical condition they choose, regardless of what the drug’s label says. Academics, patients, and essentially anyone who isn’t a salaried employee of a pharmaceutical company, are also free to discuss off-label uses, to publish about them, and in the case of patients, to inject or ingest products off-label. In US v. Caronia, the appeals court found it unjust – under the First Amendment – that pharma marketers be left out of the conversation, so long as the information they’re sharing is true, and not false or misleading.

“One of the things this decision does is to switch the burden of proof,” says Alan Bennett, partner at the law firm Ropes & Gray, and a former attorney in FDA’s Office of the General Counsel. “It’s very easy to say something is off-label. This decision certainly maintains, as it should, that FDA has the authority to go after false or misleading speech. But I think it switches the burden of proof, so that FDA has to show that something is false or misleading rather than simply off-label.”

In the case of Alfred Caronia, a sales rep working for Orphan Medical (now Jazz Pharmaceuticals) and promoting Xyrem – a drug with gamma-hydroxybutryate (GHB) as its active ingredient, which is federally classified as the “date rape drug” – Caronia was caught on tape having discussions with physicians about a litany of off-label uses, including the suggestion that Xyrem might be used to treat fibromyalgia, periodic leg movement, restless leg and other muscle disorders, chronic pain, Parkinson’s disease and potentially multiple sclerosis. Xyrem’s label at the time contained only two indications: for patients with narcolepsy who experience cataplexy, and narcolepsy patients with excessive daytime sleepiness.

Whether or not Caronia’s off-label statements were “true” at the time of the speech, in 2005, or if they are true today for that matter, was not considered and did not have any bearing on the appellate court’s decision. The statements were assumed to be true, or true enough, and thus protected under the commercial speech doctrine and the First Amendment. Caronia was prosecuted under the strict language of the FDCA, which prohibits “introducing a misbranded drug into interstate commerce.”

The decision does not prevent government regulators from prosecuting other types of misbranding, such as the failure to present fair and balanced information in advertisements, for example, but if the decision stands – and Bennett says it’s too early to tell how this decision will shake out – it puts an end to the “blanket rule that says: off-label speech is a violation and by itself creates misbranding.”

For the sake of argument, let’s assume that the decision does stand, and drug labels lose their status as preeminent deciders of what in fact is true in relation to a prescribed medicine. How might regulators – and pharmaceutical companies – agree on what constitutes the truth?

“My guess is, the safest way for the FDA to assess truth would be to begin using the Federal Trade Commission (FTC) standard,” says John Kamp, executive director of the Coalition for Healthcare Communication, and a First Amendment advocate. “It’s safe, because it has been litigated under the First Amendment for 40 years.”

The FTC’s jurisdiction extends to over-the-counter (OTC) products, and the test it applies to assess whether speech is misleading is “quite a strict one,” says Lee Peeler, president and CEO of the National Advertising Review Council, and the FTC’s former deputy director of the Bureau of Consumer Protection. “If you conduct a test and find that [commercial speech] is misleading to 20 percent or more of the [targeted] consumers, then that has been held to be actionable under the FTC Act.”

Further, under the FTC Act, “speech is, per se, misleading if you don’t have competent, reliable scientific evidence supporting the claims that you’re making,” says Peeler. “You can’t go out and say things in advertisements – for laundry detergent, diapers, OTC drugs, whatever – unless you have good strong viable data showing that the claim as the consumer perceives it, is true.”

It’s not hard to imagine that regulators and pharmaceutical manufacturers, when it comes to marketing drugs to physicians, might disagree on what constitutes legitimate, or at least reliable, scientific data. Peeler says FTC “has a multi-pronged test that it uses to evaluate” the veracity of scientific data. “One of the key pieces of the test is that the data be of a quality and type that experts in the field would consider to be reliable,” says Peeler. “In a number of recent cases in the food and dietary supplement area, FTC has required two well-controlled clinical studies for any claims about the effectiveness of a product on the structure and function of the human body.”

Asked what does or should constitute – or better yet define – truthful versus misleading or false speech in the context of off-label discussions, PhRMA’s EVP and general counsel Mit Spears issued the following statement: “Federal jurisprudence provides a rich body of precedent, drawn from cases arising under the Lanham Act, FTC Act and a host of other statutory and regulatory regimes, that balances the rights of companies to engage in commercial speech with the consumer’s right to receive accurate and truthful information. As always, PhRMA stands ready to work with FDA to make sure that both patients and health care professionals receive timely and accurate information about medicines, which will improve health outcomes and protect patients.”

FDA and industry will need to come to an understanding on what exactly is needed to substantiate a product claim, if US v. Caronia holds up and product labeling isn’t the be-all and end-all conduit for truthfulness. The decision “should lead, I hope, to a thoughtful reassessment about the way the regulatory system [for pharmaceuticals] works,” says Bennett. “I do think there’s some information out there that’s outside of the technical four corners of the label that would be useful for physicians to have, and companies have the means to disseminate that information, as long as it’s truthful and not misleading.”

Indeed, under the “existing rules of the FDA, using comparative effectiveness research (CER) in marketing materials is most often illegal for companies,” says Kamp, due to the fact that CER is compiled after a drug and its label hit the market. “But it is not illegal for anyone else to use economic studies against companies.”

Bennett offers the example of treatment guidelines, which are “developed independently of companies, sometimes by government…and to say that everybody else can talk about that information, and that it’s good information, but that the company itself can’t talk about it, that doesn’t seem like a great system.”

In off-label conversations, though, it’s usually the pharmaceutical rep that has more skin in the game, financially speaking. Based on recent Supreme Court decisions, including Sorrell v. IMS Health – which is referenced and relied upon heavily in the US v. Caronia majority opinion – the contemporary system of American jurisprudence seems willing to overlook the financial motives which often lead to speech, and any questions of inherent bias therein, so long as the content of the speech in question meets muster. In the age of big data, it will be interesting to see how regulators and industry collaborate to produce an acceptable truth for everyone else.