On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based company with a stage three compound (pimavanserin) targeting Parkinson’s disease-related psychosis.

A month ago, Acadia met with FDA to discuss the proper design of a new phase III trial intended to confirm the results of a previous, 17-month study that met its primary endpoints. A confirmation trial was needed, Acadia presumed, since the first phase III trial of pimavanserin, conducted in 2009 at half the dose of the successful trial, had failed. Acadia had already begun to enroll patients in the confirmation trial – which represented an $18 million commitment – when it met with FDA in April to get the agency’s blessing.

To Acadia’s surprise, FDA responded that the additional confirmation trial wouldn’t be necessary, based on the pivotal phase III trial already on the books, combined with supportive data from other studies on pimavanserin. As a result, Acadia scrapped plans to do another trial, and began preparing its NDA posthaste. But the company wasn’t hasty enough, and investors dialing in to a call about the FDA meeting balked at the company’s projected filing date – near the end of 2014. Why not file immediately, they wanted to know? Acadia executives’ refrain in response, was, “these things take time.” FDA had reversed the waiting game, making Acadia itself responsible for the delay in review and commercialization of a new product.

This is just one example, of course; it isn’t likely that a big pharma looking to introduce another DPP4 into the market for type 2 diabetes, for example, would be told not to worry about additional trials studying cardiovascular or pancreatic side effects. But the fact remains that FDA approved 39 NDAs in 2012 – the most since 1997 – and the agency launched yet another expedited regulatory pathway – breakthrough therapies – at the beginning of 2013. The breakthrough therapies designation is likely to shorten the timeline from discovery to commercial approval – for those drugs receiving the designation – to between three and five years, according to IMS estimates.

Rachel Sherman, associate director of medical policy and director of the Office of Medical Policy, CDER, FDA

The timeline from discovery to approval could be as short as 26 months, said Rachel Sherman, FDA’s associate director of medical policy at the Center for Drug Evaluation and Research (CDER). Sherman said her office had received – to date – 39 requests for breakthrough therapy status, of which 12 have been granted and 14 denied, with 11 pending and two withdrawn. She said the breakthrough therapies program is already “an enormous success.”

Joseph Herring, CEO at Covance, noted that pharmaceutical companies are often difficult to work with, from his perspective as the head of a CRO. “[Investigators] want a perfect trial that can’t be enrolled.” He wondered about the interplay companies have with FDA regarding trial design discussions. In response, Sherman advised more communication. “If what we say doesn’t make sense, ask us. Argue with us. We’re receptive to it.”

How does a company know whether it’s sufficiently engaged with FDA? “If your lead clinical person is on a first name basis with the [respective] lead reviewer at FDA, you’re in good shape,” said Sherman. “If you’re not, you’re not.” Sherman cited the Clinical Trials Transformation Initiative as another program aimed at “identifying and promoting practices that will increase the quality and efficiency of clinical trials.”

“The point of all our programs is better evidence generation…we lack evidence,” said Sherman. “The most expensive drug is the one given to the wrong patient, or given incorrectly.”

On the subject of biosimilar approvals, Sherman said FDA hasn’t received a single application yet, adding that the phrase “follow-on biologics” is dead. The requirements for biosimilars, according to Sherman, are that a biosimilar be “highly similar” to the original product, with “no clinically meaningful differences.” Sherman said that does not mean “interchangeability,” though, suggesting that a biosimilar could not be substituted for a brand biologic at the pharmacy, without specific doctor’s orders.

Comparing the current activist FDA with the activism the agency demonstrated during the HIV epidemic, Werble said that in addition to the breakthrough therapies designation, FDA has also launched the GAIN ACT, and its anti-infective exclusivity provision; has opened up FDA meetings to rare disease outside consultants, who advise companies on efficient FDA regulatory navigation; and has implemented PDUFA 5’s “patient-focused drug development meetings,” which solicit patient opinions around specific diseases.

Speaking on the “agency-wide impact of management attention and staff commitment” mustered during the HIV crisis 20 years ago, Werble said the pendulum has once again swung back toward FDA activism. “That commitment [to HIV] was infectious 20 years ago, and it’s occurring again,” said Werble. He also noted that a solid one-third of all drug applications submitted to FDA now come from small companies, a rejection of the thesis that only big pharma is properly equipped to navigate FDA’s regulatory structure.

The Rutgers Business School Annual Healthcare Symposium, convened on April 30, was presided over by Mahmud Hassan, director of the Blanche and Irwin Lerner Center of the Study of Pharmaceutical Management Issues, at Rutgers. John Castellani, president and CEO of PhRMA, and Seyed Mortazavi, president of IMS Health US operations, also gave presentations.

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.

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.

FDA is immovable on the requirement that a drug be “effective” as a prerequisite to approval, said Russel Katz, director, division of neurology products at FDA, on a panel at the Prix Galien Forum last Tuesday. Once that requirement is met, insisted Katz, the agency is flexible in other areas, including the consideration of alternative clinical trial design for drugs targeting Alzheimer’s disease, like adaptive trial design, and “seamless phase II/III” trials, which can be used to speed up the regulatory process.

With respect to biomarkers and surrogate endpoints as measures of a product’s effectiveness, Katz said it’s “understood that there’s an allowance for uncertainty…more so than in other [therapeutic areas].” The standard for product evaluation, Katz said, is whether or not it’s “reasonably likely” that “an effect on surrogate endpoints or biomarkers predicts efficacy” in patients.

Katz also made a pitch for combination therapies as a would-be-welcomed approach to Alzheimer’s disease. Unlike other therapeutic areas, “there is a tremendous reluctance to test combination therapies” for Alzheimer’s disease, he said. Disease modifying drugs for Alzheimer’s – as opposed to products like Namenda or Aricept that help patients manage side effects or certain aspects of the disease – aren’t likely to hit the market in the near term, even though panelists predicted that caring for Alzheimer’s disease patients would top $1 trillion annually by 2020 in the absence of a significantly efficacious new therapy.

One of the problems, according to panelist William Thies, chief medical and scientific officer at the Alzheimer’s Association, is that there “isn’t true agreement on biomarkers that predict clinical benefit,” but “in the next 12 to 18 months, there will be.” If the beta amyloid target, for example, could be validated beyond dispute, it would embolden pharmaceutical companies to “go forward more often with potential drug candidates,” said moderator Michael Rosenblatt, EVP and chief medical officer, at Merck.

Despite mixed reactions to the phase 3 EXPEDITION trial data, and slightly more positive reactions to the data remix performed by the Alzheimer’s Disease Cooperative Study, an independent national research consortium, Lilly’s solanezumab trials have helped to further “establish some biomarkers and endpoints,” said panelist Dennis Selko, Harvard Medical School professor and co-director, Center of Neurologic Diseases, at Brigham and Women’s Hospital.

Aside from the fact that Alzheimer’s disease affects “the most complicated functions of the most complicated organ,” per Thies, two other key blockages exist on the pathway toward new therapies: the first is a lack of sufficient funding for basic research. Four hundred and fifty million dollars is spent annually on basic research into Alzheimer’s, compared with $6 billion in cancer, and between $4 and $5 billion in heart disease, said Thies. Proper funding for basic research in Alzheimer’s would be around $2 billion annually, he said.  The second barrier to progress is the sluggish nature of clinical trials in this space. There’s not a ready-made population to participate, so it often takes “two years to recruit your cohort, and two years to conduct the trial,” and often longer, said Theis.

Meryl Comer, president of the Geoffrey Beene Foundation’s Alzheimer’s Initiative, noted that the average Alzheimer’s caregiver – often a patient’s son or daughter – is on average 47.5 years old, and still very much in need of a full time job, and often supporting children of his or her own. Comer found out that she is predisposed for Alzheimer’s disease herself, after reading the results of a genome scan on national television. Comer said the reason she agreed to reveal her genetic information on ABC’s Nightline was to “make a public statement.” Instead of fretting over anecdotal evidence related to inheritance and instances of the disease among family members, it’s better to get tested, and find out definitively, early on, she said. As a result, “I will go into early-stage or preventative trials,” to help move the science forward, said Comer. The decision to have her genome sequenced was personal, too. “I don’t want my son to have to care for me…I don’t want to be remembered that way,” she said.

The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly, but they are – at least Big Pharma is – spending more on so-called inbound social media software and analytics, which lets them listen to what is being said online about brands and unmet needs and match that up marketing strategies.

A new report from IDC Health Insights, titled “Worldwide Pharmaceutical Social Media Analytics 2012 Vendor Assessment,” found that pharma marketing departments are “starving for new ways to measure market sentiment, competitive analysis and promotional effectiveness” in areas that were previously difficult to gauge, according to Eric Newmark, program director, life sciences, IDC Health Insights and author of the report. “Companies are trying to answer questions like, ‘What are the sentiments being shared by our highest targeted physicians about brands in popular online communities,’ or ‘What is the biggest unmet need among our highest targeted physicians?’”

Insights gleaned from listening in to social media conversations aren’t being widely integrated at an enterprise level just yet, but pharma is “becoming increasingly interested in integrating this information back into the broader spectrum of CRM and sales and marketing intelligence, so they can start to relate what they’re seeing online back with the actual customer profiles and CRM systems…that gives them something closer to a 360-degree view of what physicians are saying online, and actually tying that back to a [physician] profile,” says Newmark.

Some companies continue to use third party service providers as a kind of regulatory buffer, in the belief that keeping a social media wiretap at arm’s length protects them from having to report adverse event discussions – discussions which may or may not meet FDA’s criteria for reporting – but source validation, relevancy, and weighting one online conversation against another, is becoming a strong area of focus and attention for pharma, says Newmark. “You don’t want to be misinterpreting what’s out there.”

So who are the top vendors, according to Newmark’s six months of research and discussions with pharma? The leaders, in no particular order, include Indegene, Cognizant, ListenLogic, Genpact and Semantelli. On the next rung down – major players – Visible Technologies, Genpact and Radian6 made the cut; all have experience working with top pharmas.

Companies have misjudged the market in the past – Newmark gives an example of a pharma company focusing on the “fast-acting” capabilities of a product, when, come to find out, patients aren’t as concerned about fast-acting as they are about specific side effects – which makes listening software, or monthly reports from service providers, a valuable tool in the marketing arsenal.

Minister David Willetts

Public payer groups at the local level are calling national policy mandates too expensive for implementation, and have responded by disobeying them directly, or by simply dragging their feet, to see what will happen. Sound familiar?

Disputes between national and local healthcare institutions aren’t unique to the United States, and the access gap among certain PCTs in England will be addressed directly – in the form of monetary penalties – beginning in 2013, according to comments made by David Willetts, Minister of Universities and Science, at the BIO conference last month in Boston. The new strategy for UK life sciences, according to Willetts, will include “budgetary penalties where innovation in the NHS is not being used…and that will kick in next year,” he said.

The basis for levying budgetary penalties on NHS rests on the fact that once the National Institute for Health and Clinical Excellence (NICE) endorses the use of a new innovative drug – an accomplishment remarkable enough in its own right, from industry’s perspective – then NHS is obligated to make that drug available through its various channels, including the local PCTs. That doesn’t always happen, however. “Recent research has shown that probably one in four [PCTs] blacklist drugs that have been approved by NICE,” says Claire Gillis, CEO at the WG Group, a UK-based consulting firm. “PCTs are saying, these drugs may be approved by NICE at a national level, but actually for us, in the localities, they’re too expensive or they’re not effective in our view.”

Faced with a potential funding penalty, NHS may indeed expedite adoption of new drugs and technologies in some localities – Gillis says she expects metrics to be put in place during the fourth quarter – but in the meantime, NICE chairman Sir Michael Rawlins has publicly advised patients to file a lawsuit if they can’t get access to an approved treatment they need. Speaking with the Financial Times earlier this year, Rawlins said: “I just wish a patient organization would take a [PCT] to court for failing to comply.”

That solution is perhaps a manageable one for the courts in England, since litigation losers – those who file a lawsuit and lose – must pay the defendant’s legal fees, a strong disincentive for frivolous suits. Neither solution, however, tackles the issue of where additional funds will come from to make new drugs available faster. If PCTs can’t afford to pay for new drugs in the first place, it isn’t clear how the situation be improved by penalties in the form of budget cuts.

The problem is a critical one. As new drugs for conditions like Alzheimer’s or autoimmune diseases emerge, patients forced to wait – for years in some cases, if the system doesn’t change – will miss their window of opportunity for effective treatment. As these patients’ conditions worsen, they only get more expensive to treat.

Big pharma talks a lot about the changing business model and placing a new emphasis on patients, but the fact remains that quantity of medicines sold, not quality of care provided, is how to get paid (and how to keep investors happy). Despite its egalitarian trappings, the healthcare “ecosystem” is still dominated by the most skillful hunters, those who capture the most prey. However, new provisions inserted into corporate integrity agreements (CIAs) between government and pharma – GSK is the latest victim – could force companies to actually change their model, or pay the price.

Greg Demske

Two summers ago, GlaxoSmithKline (GSK) made a lot of noise about the fact that it was eliminating sales-based compensation and bonuses for US-based sales reps. Instead of rewarding the biggest sellers, a sales rep’s bonus would, beginning in 2011, be determined in part by “customer feedback, and by a sales professional’s adherence to the company values of transparency, integrity, respect and patient focus,” according to a press release dated July 26, 2010.

In the release, Deirdre Connelly, GSK’s president, North America pharmaceuticals, said “physicians have been telling us they want to see fewer sales professionals, and those they do see need to provide greater value in helping improve patient health. In response, we are changing the way we sell our medicines and vaccines in order to deliver the value our customers demand, in a transparent way, with integrity and respect for the patient.”

The story got a lot of play in the media, and has been used as a congratulatory example of how one of the major industry players is taking real steps toward changing the pharma business model from one based on sheer volume selling, to one focused on patient health outcomes. GSK’s “Patient First program” may indeed have been created in response to physician feedback, as Connelly described, but it was also created in response to the Office of the Inspector General and the Justice Department.

GSK “developed the [Patient First program] in response to the investigation and the information brought to them by the government,” said Greg Demske, Chief Counsel to the Inspector General, in an exclusive interview with PharmExec. That investigation was concluded on July 2, when the Justice Department announced that GSK would pay $3 billion – the largest settlement ever – to close the book on alleged off-label marketing practices in support of Paxil and Wellbutrin, two anti-depressant drugs; for allegedly hiding safety data related to Avandia, a diabetes drug; and for allegedly false price reporting practices.

While the dollar amount itself is significant, it wasn’t a surprise; in January 2011, GSK announced that it had stashed away $3.4 billion to cover the costs of an inevitable settlement with government. The leftover $400 million may come in handy as GSK begins to think about meeting the compliance requirements of its new 122-page CIA, which begins in 2013 and includes provisions never before seen in a pharma CIA, including the one GSK signed in 2003 as part of a $88 million settlement that ended False Claims litigation related to Paxil and Flonase. CIAs are five-year agreements, so the old one expired in time for the new one to take effect, and GSK joins a large and growing crowd of CIA signees. Of the top 10 pharma companies (as identified by this year’s PharmExec 50), only Roche is not currently bound by a CIA.

“The GSK CIA is very significant because it does address the issue of financial incentives for individuals within [GSK], in a way that we have not done in the past,” says Demske. “There are two major ways that we do that: one is compensation for sales people; GSK’s current system breaks the tie between sales person compensation and the volume of business that they’re generating, and the second part is the claw-back provision.” The claw-back provision, also known as the “executive financial recoupment program,” mandates that GSK establish a program that “puts at risk of forfeiture and recoupment an amount equivalent to up to three years of annual performance pay (i.e., annual bonus, plus long term incentives) for an executive who is discovered to have been involved in any significant misconduct,” according to the text of the CIA. In other words, GSK execs have real skin in the game. The cost of doing business just got a little bit pricier.

“The idea is to try to change the financial equation for people at the sales level and the executive level, so the executive isn’t just thinking, ‘Well, the more profits that are generated, the more bonus I get,’ but also thinking, ‘If I cross the line, I may have some of my money on the line, and I may lose that bonus, and maybe even more than that,’” says Demske.

There are other new provisions in Glaxo’s CIA, too. Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General, points to an expansion of the famous “Dear Doctor” program that requires a pharma company working under a CIA to send out a letter notifying physicians about the settlement. “This CIA goes one step further…there’s also a requirement that [GSK] send a letter to payers, government and other payers with which the company has rebate agreements, to notify the payers about the settlement,” says Riordan. “Part of the purpose of that provision is to really focus the company’s attention on the relationship that GSK has with government payers.” The “Dear Payer” letter is “not something we have required before,” says Riordan.

In addition to the provisions cited above, other CIA requirements “reflect what GSK was already doing,” like restrictions on the way funding is provided to third party medical education organizations, and which organizations are eligible. Another example, unique to GSK’s CIA, requires that a physician – if requesting off-label information from a rep – sign a form stating that the request was unsolicited. This is an example of a program already instituted by GSK, but reinforced by the mandate of a CIA. “That provision is part of a broader section [III.B.3] that talks about policies and procedures that the company has to maintain,” says Riordan. “We were sort of memorializing and binding GSK to abide by those policies and procedures during the course of the CIA,” which lasts through 2017.

By design, CIAs are forward-looking; they exist as a way to help protect government programs from fraud, waste and abuse. But can CIAs help push industry into the new business model they seem ready to embrace, if only the financial models could be changed? “I would say that the we are constantly looking at the CIAs that we have, and what we’re receiving under the reports from those CIAs, and constantly assessing what we think is effective, and what should be in future CIAs, and other things that we should not use in the future,” says Demske, adding that the Office of Inspector General conducted a round-table with pharmaceutical companies to get feedback on which provisions – from an industry perspective – are most effective in promoting compliance. A report based on the round-table findings was published, and classic CIA requirements like sales rep ride-alongs, physician payment disclosures, best practices for working with Independent Review Organizations, and of course, changing business models, are weighed and discussed.

Regarding industry compliance, “we have very few instances of non-compliance with CIAs with these major pharmaceutical companies,” says Demske. “In our experience they put a lot of resources into insuring that they are in compliance…I think it’s fair to say the pharmaceutical industry has had a good record of compliance under CIAs.” Understandably so, given that monetary penalties and exclusion from government programs are the two primary dangers of non-compliance. If pharma could comply with the law to begin with, perhaps the OIG and Justice Department wouldn’t have to come up with new provisions to prevent law-breaking in the future. Or maybe the old business model perpetuates overselling and excess utilization, and government CIAs will be one of the tools that finally helps push industry into selling quality instead of quantity. Either way, expect the CIAs of the future to be much more comprehensive than the CIAs of the past.

There are many differences between the two bills, but most are expected to be resolved fairly easily. Both bills reauthorize user fees for drugs and biologics and medical devices and establish new fee programs for generic drugs and biosimilars. The measures contain similar provisions for expediting the development and approval of critical new therapies and treatments for rare diseases. And they drop the long-time requirement that FDA inspect drug manufacturers every two years, permitting a risk-based approach instead.

Although the two bills propose to enhance pharmaceutical supply chain security, there are notable differences in the specifics for registering drug establishments, deterring counterfeit drugs, halting illegal imports, and addressing drug shortages. The bills also vary in how they provide incentives for the development of new anti-infective drugs and loosen conflict-of-interest rules governing advisory committees.

A notable difference in the Senate bill (S. 3187) is a “place holder” for establishing a drug track-and-trace system. Other unique provisions encourage third-party drug inspections, require reports on the inclusion of subgroups in clinical trials, and prevent innovator firms from blocking generic drug maker access to drugs covered by postmarket limited distribution programs. The Senate measure also strengthens protections for FDA whistleblowers and requirements governing public registration of clinical trials. And there’s sure to be debate over a late provision that stiffens controls on hydrocodone-containing pain meds.

The House bill (H.R. 5657), in turn, makes it easier for sponsors to modify REMS (risk evaluation and mitigation strategies) and for FDA to block and destroy adulterated and counterfeit products. It enhances access to generic drugs by speeding up FDA review of petitions and providing for forfeiture of 180-day exclusivity under certain conditions. These provisions are important because more generics translates into reduced federal outlays for medicines, which makes the legislation a money-saver that meets federal deficit reduction requirements.

Among other things, the conferees will have to agree on what to call the bill—the FDA Safety and Innovation Act (FDASIA), as proposed by the Senate, or the FDA Reform Act (FDARA), as in the House. Backers of the legislation aim to send a final bill to the White House by the end of June—and avoid getting tangled up in new health reform proposals sure to erupt from the Supreme Court decision on the Affordable Care Act.

“Traditional market research about advertising is often wrong,” said Yadav, noting that his experience as an ethnographer put the fundamental tool of social science – self-reporting – into question. “I’d spend a lot of time with someone, and then give them a survey, and [on the survey] they were not the same person,” said Yadav. “People don’t have the ability to express emotion…if I ask how you feel, the response is how you think you feel.”

To bypass the speech/articulation process, Australia-based Neuro Insight uses steady-state topography (SST), which records electrical impulses in the scalp via a sensor-bedecked visor worn by test subjects. Put in front of a television and shown advertisements, subjects’ brain waves register their levels of “approach” or “withdrawal” from a given ad, which lets marketers predict the ad’s effectiveness, or adjust the content to prevent a dive into withdrawal. Neuro Insight has pharma clients – GSK is listed on the company website – but the case studies were limited to consumer brands, an unfortunate but familiar trend at digital pharma gatherings.

Moving from brain waves to search results, Steve Rotter, VP marketing at Brightcove, a web video hosting and service provider, cited data from Forrester proclaiming that “videos are 53 times more likely than text pages to appear on the first page of search results.” But the written word isn’t completely dead; Rotter said adding a transcript of a video to a webpage dramatically improves SEO and helps visitors find what they’re looking for more quickly. Brightcove has clients including AstraZeneca, Abbott, Genzyme, Roche and GSK, and is currently working on a platform for videos that senses which specific device is being used by the target consumer or patient, and optimizes or renders the video based on that device, said Rotter.

Doug Seifert, president and CEO at Syandus, an “experiential learning” company, demoed a COPD simulation game targeted to physicians. Created for Pfizer and Boehringer Ingelheim (the companies co-market the blockbuster COPD drug Spiriva), the demo was one of the most impressive displays at the conference. The game allows physicians to adjust variables and see how patients with different levels of severity or disease-state would respond. A doctor can make a patient smoke cigarettes and climb stairs, and then watch what happens in the body, for example. Seifert said simulations work because “humans are pattern recognition machines,” and “pattern recognition creates behavior change.” Besides, “endorphins are released” when people play games, a word Seifert defined as “a series of interesting choices.”

The conference ended on a somewhat hypocritical note, in that Facebook – “a distribution platform that promotes authentic sharing” – struck all sharing of its presentation from the record. Conference emcee Ritesh Patel, Chandler Chicco’s digital and social media lead, asked that all remarks from Facebook’s John Patten be kept within the walls of the Alexandria Center’s conference room, given the company’s upcoming IPO. As a result, the tweeters in the room (conference tweets can be found at #CCCDigital) were silenced for the duration.

I’ve been doing this digital thing for some time now. I’ve been part of and witnessed many changes in our digital world. However, I have never seen such a swift pace of change and digital adoption of late. It’s stunning how quickly things spread and how fast things scale and get adopted.

Look at the gathering known as South by South West, or SXSW this year. A record number of people attended with the largest turnout of startups. SXSW has now become the place for the next new startup to make it. Last year was all about location based services, with Foursquare being the favorite, this year was the year of Ambient Social with companies like Highlight, and Glancee creating a buzz.

I never imagined that people would be lining up to buy that new iPhone or iPad, overnight in some cases. The speed of adoption of a new Apple product and the global reach of the company has been interesting to watch. They have created massive new markets and completely changed our view of technology and our habits and expectations.
And now we have the social networking phenomena? Five years ago people never shared any private information with anyone unless they were their closest friends. It was unthinkable to go up to a total stranger and tell them what you had for lunch or broadcast to them what you are doing during your day. However, millions of people, and in the case of Facebook, 850 million of you, do it as a matter of habit and don’t think about it. The likes of Facebook, Twitter, LinkedIn and YouTube have forever changed how we live, work and share our lives with our friends and colleagues.

In the healthcare industry, a highly-regulated, predictable and conservative environment, this change is unnerving and potentially harmful.

Do you remember in 2009/2010 how our industry was struggling to figure out what do to about social networks and their impact on our business? Many thought the answer would appear magically after the infamous FDA hearings were over in November of 2009. Alas it was not to be. So while we have mostly understood what can and cannot be done on social networks, a lot of people are erring to “cannot”… but the change goes on.

In 2011, we saw a maturation of understanding of social media within many major pharmaceutical companies. Even with this understanding, engagement was nonexistent.

As we continued to try to keep up, we completely underestimated the growth of mobile and in particular the impact that new thing called the iPad would have on our business. I suspect that e-detailing laptop/tablet that corporate IT issues to the sales rep days are numbered. The pace of adoption of the iPad and iPhone both by us and also by HCPs and patients is forcing us to rethink our business. A recent study suggests that by 2014, access via a mobile device will finally outpace access via a desktop PC.

So what’s in store for 2012? I predict it will be more of the same. Ambient Social will be the buzz word of the year. Frictionless sharing is another phenomenon that Facebook will force upon us. Video will become very big and finally, with the advent of the Electronic Health Record, Big Data will become part of our daily vernacular.
How does one keep up with all this?

Well, we thought we would do our part and help by creating a one-day forum called Pioneers in Digital Health. We thought we would bring together folks who are doing incredible things in digital marketing and communications that we could learn from and hopefully stay informed and potentially stay ahead of the curve a bit.

Try to attend if you can. I promise it will be a day well spent.