The code, which is open for public comment until June 30^th, states that “no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe” a drug. Additionally, “gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) also are not [to] be offered or provided,” the code states.

However, some concessions are made for continuing medical education (CME). For example, pharma companies may provide monetary assistance covering “actual travel expenses, meals, refreshments, accommodation and registration fees” for physicians, but the events and expenses “have to be organized in India only…and incurred only for the events held in India.” Assistance funds are not to be extended to “spouses or other accompanying persons” hoping to travel to CME events, and companies are barred from organizing meetings that “coincide with sporting, entertainment or other leisure events or activities.”

On his MedCom Strategies blog, Dr. Neelesh Bhandari, a New Delhi-based medical communications consultant, took issue with the rule about meetings coinciding with other events. “This is a totally uncalled for limitation. Why shouldn’t healthcare professionals attend meetings because of the IPL [Indian Premier League] being held at the same time?” wrote Bhandari. The IPL is a professional cricket league.

Other proposed rules in the code limit drug sampling “to prescribed dosages for three patients,” and sample packs “shall not be larger than the smallest pack presented in the market.” Providing samples of “anti-depressant, hypnotic, sedative or tranquillizer” drugs in any amount or packaging unit is disallowed, under the proposed code.

Regarding textual and audio-visual promotional material, marketers are prohibited from using the “names or photographs of healthcare professionals.” Marketers are also asked to avoid “extremes of format, size or cost of promotional material.” On his blog, Bhandari wondered if that rule would “limit the size and costs in pharma marketing projects.” Audio-visual material “must be accompanied by all appropriate printed material” as well, prompting Bhandari to suggest that “this could kill digital pharma marketing in India.”

The full document and code is available here. The regulations are voluntary for now, but “its implementation will be reviewed after a period of six months form the date of its coming into force, and if it is found that it has not been implemented effectively…the government would consider making it a statutory code,” the document says. The Department of Pharmaceuticals is a division of India’s Ministry of Chemicals and Fertilizers.

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end.

Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.”??Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

Walter Armstrong

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I was at the 2nd European DigiPharm conference in London last week. I didn’t manage the whole two days, but what I did see left me a little concerned that pharma is still struggling with digital marketing.

This is not a criticism of DigiPharm organizers. Intermitent Wifi woes notwithstanding, the  event was executed with surgical precision. It’s not a criticism of the presenters I saw, they delivered their messages with style and offered good solid advice. And it’s certainly not a criticism of the enthusiastic audience: DigiPharm was packed, row after row of eager marketing execs, laptops, iPads and smartphones at the ready, eagerly tweeting nuggets out to those less fortunate and unable to attend.

My concern centres on the obvious disconnect between the conference speakers, the people in the room and their bosses, or maybe their bosses’ bosses. Some of the questions and comments from the floor were from people genuinely nervous of breaking out of the digital marketing 101 mindset. My least favorite one-liner of the day was this: “If you’re not in digital marketing within five years you’ll not be in marketing.” It strikes me that this was true in other commercial sectors five years ago. So what, all the analog marketers moved to pharma?

There are great digital marketing initiatives and great digital marketing people out there in Pharmaland. But whether its lack of regulation, fast-moving technology, big-company bureaucracy, risk aversion, whatever, the excuses are running out.

I came away feeling sorry for attendees who got all fired up at this conference, only to go back to the digital desert of their home offices. My big takeaway from Digipham 2010? Never mind engaging with patients and HCPs, pharma CEOs need to start engaging with their own marketing people, listening to their strategies and their concerns, and give them the support they need to execute innovative digital campaigns and ongoing social media programs.

I’m not saying it will be easy, but for an industry that’s headline objective is to cure cancer, it shouldn’t be impossible.

The survey incorporated responses from more than 4,000 physicians worldwide. Reps were rated on a number of criteria such as objective and ethical behavior, quality of medical information, and professional relationship. Physicians were asked to rank the leading three companies by the above criteria, according to their experience and perception.

In India, when physicians were queried about “quality of professional relationship”, domestic companies received better ratings, with Mankind, Cipla, Lilly and Lupin topping the rankings; in China, doctors rated domestic player Yangtze River well when it came to objective and ethical behavior, but also gave high marks for western companies like GlaxoSmithKline, Merck, and Pfizer.

In Brazil, Eurofarma, GlaxoSmithKline and Bayer scored best among secondary care specialists, while in Japan, when asked about quality of information provided, primary care doctors gave Tsumura, GlaxoSmithKline, AstraZeneca, Takeda and Shionogi the highest ratings.

“[T]he companies that have risen to the top have honed their ability and skills in terms of what doctors want,” Christopher Wooden, Cegedim Strategic Data’s director of global sales and marketing told Pharmaceutical Executive. “In the emerging markets they are taking their experience with them.”

For further survey results, click here.

In the last two years, FDA has twice cited Baxter for similar violations. In April 2009, it sent the company a warning letter indicating that select promotional materials created in support of Tisseel (a fibrin sealant) were false or misleading. In July 2008, the Agency’s Office of Compliance and Biologics Quality (OCBQ) issued an untitled letter to the company over claims about its anti-inhibitor coagulant complex, Feiba VH. The letters are not legally binding, but FDA can follow them up with litigation if they are ignored.

FDA told Baxter in the latest letter that it is “very concerned by your continued violative promotion of your products.” The agency requested that Baxter cease dissemination of the Araplast brochure and respond in writing about how it intends to bring its promotional material in line with the Federal Food, Drug, and Cosmetic Act.

Baxter reports that it has since sent a letter of response to FDA and put its promotional material for Araplast on hold. In a statement issued Aug. 31, the company said it “has confidence in the strength of its promotional review policies and procedures and a history of collaborating with FDA. [Baxter] will continue to work with FDA to ensure the company is in compliance with all relevant rules and regulations.”

ACCESS TO MEDICINE INDEX 2010

GlaxoSmithKline ranked number one in a study of pharmaceutical companies offering access to medicines to emerging and developing nations, proving that the UK drug giant has a far stronger grasp on new markets than its US and Japanese counterparts.

The study ranks 20 companies based on significant criteria including pricing, patents and intellectual properties, capacity enhancement, marketing, lobbying tactics, competition, and philanthropy.The study was the brainchild of Wim Leereveld, founder and chairman of the NGO, Access to Medicine Foundation, in partnership with research firm Risk Metrics.

This is the second index that the foundation has published. The first, released in 2008, featured data submitted from only nine companies. This year, 19 of the 20 pharma firms were open and transparent with their information.

High Marks All Around
So what separates GSK from the competition?

“GSK has integrated access to medicine into its core business model, so it’s not philanthropy, it’s really part of the way they do business and part of their understanding of the importance of emerging markets,” said Afshin Mehrpouya of Risk Metrics. “As a result, they are heavily engaged in research for neglected diseases. At the same time [they are] able to sell their drugs in the emerging markets, they help with the development of the infrastructure.”

Companies at the middle or the bottom of the list treat access to medicine as a tactical issue rather than including access to medicines as a major part of their business, Mehrpoua explained.

The biggest mover among Big Pharma companies was Pfizer, which ranked 17 in 2008, but moved up to number nine this year.

“Pfizer is now seen as a player,” Leereveld said. “The company has changed dramatically. All the people [in that division] are gone and there is a new team that see [access to medicine] as a very relevant matter to perform in developing countries and they did their utmost to get their data together.”

European companies, in general, have has a longer history operating in emerging markets, giving them a lead on Japanese and American firms that relied for many years on local markets for sales.

“Given the saturation of the Western market, the decline of the blockbuster drugs, and the fast growth of the emerging markets, companies like Pfizer are moving faster to catch up with their European counterparts,” Mehrpouya said.

The stated aim is to assist FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) in its efforts to deter promotional activities. DDMAC examines promotional pieces submitted to the agency, scans ads and TV commercials informally, and monitors drug company exhibits and programs at medical meetings. An important source of information is all the complaints the division receives are from industry competitors who see another company getting away with off-label promotion or unfair comparisons. It’s impossible for DDMAC to catch everything, and certainly not what’s said in meetings between doctors and sales reps or at sponsored dinner programs.

To kick off the Bad Ad program, which was announced last month, DDMAC staffers will give talks and distribute educational materials to providers at medical conventions and society meetings. A brochure advises doctors on how to recognize misleading promos: omitting risks, overstating effectiveness, promoting off-label uses, or making misleading comparative claims. FDA is making it easy for doctors to squeal about objectionable messages by establishing a special call-in number and email address.

It’s not yet clear if the campaign will generate a lot of finger-pointing—or if it does, how DDMAC will deal reports that are vague and undocumented (anonymous calls are okay). Marketers fear that doctors will file complaints based on misunderstandings and personal prejudices. Supporters of the program anticipate that marketers and sales reps will modify their pitches if they think that their audience is taking a much closer look at what they say. But free-speech advocates like the Washington Legal Foundation fear it will chill open exchange of health information, which can be useful.

The Bad Ad campaign fits FDA’s effort to step up enforcement, as Commissioner Margaret Hamburg promised a year ago. The agency has issued 186 warning letters so far this year, putting it on track to meet last year’s record of 570 enforcement missives, according to BNet Pharma. And more of those are coming from DDMAC, which doubled its warning-letter rate to 41 in 2009, vs. 21 the year before. Many recent letters challenge Internet marketing, an activity that remains on FDA’s radar screen. In April, DDMAC sent a long warning letter to Novartis challenging the company’s use of Web sites to promote unapproved uses and to make unsubstantiated claims for Gleevec. FDA plans to develop guidelines on Internet promotion and use of social media by drug marketers, but it’s proving to be a complicated business.

Our magazine is called Pharmaceutical Executive—indicating a focus on the c-suite. But we know many of our readers aren’t executives (yet), and may not have quite the same in-depth knowledge as their bosses. So, for those who hear the term “SaaS” bandied about in conversations and fake their way through discussions about it despite not quite understanding what, exactly, it is, we present: A Beginner’s Guide to SaaS. (Those who do know are hereby dismissed.)

Software-as-a-Service (SaaS) is sort of a misleading term, as it’s not software in a traditional sense. It uses a web-based system and off-site computers—run by another company and operating in a “cloud” that is basically the internet—to collect and sort data and turn it into actionable intelligence. In pharma’s case, this would be the basis for sales force automation (SFA). Sales reps input call notes and set up calls and look at their doctors’ latest prescribing habits through this program. Line and bar graphs, sorted lists with prescribing percentages and past performance not only give reps a leg up, but let their managers keep an eye on them.

The advantages of SaaS are pretty clear: Your company doesn’t have to maintain a huge server farm and large IT department, and the company providing the service is the one that worries about fixing bugs and automatically upgrading the software. Matt Wallach, EVP and general manager of SaaS provider Veeva Systems, says it’s the difference between owning a condo or townhouse, in which you pay fees associated with homeownership and have to mow your own lawn and salt your own sidewalk, and renting an apartment, wherein you’re not responsible for any of those things. Furthermore, customization is a breeze, as customers can suggest features of their own or turn others on and off, with very little turnaround time.

Ed Gemo, Pfizer’s senior director of global SFE/marketing solution center, said switching from the “Excel and paper” model to SaaS can reduce costs per rep $3,000 or more, and Wallach said companies can expect total initial savings of $100K, plus $20K each subsequent year.

And it’s not just a way to cut costs—sales effectiveness can see a big boost from something as simple as a better-prepped rep. As Gemo said: “We’ve always had this data, but we’ve never had a good way of using it until now. Instead of listening to a customer’s needs, we just kept repeating old messages. We just screamed louder.”

SaaS may seem like a “duh” concept, especially since other industries have been using it for 12 years or more. But the far stricter regulations placed on pharma’s sales forces, and the industry’s special breed of mistrust, made SaaS adoption supremely unattractive.

Then technology advanced enough to allow for rapid deployment of new features in response to regulation and policy changes, and pharma saw the risk decrease. At least 90 percent of companies’ customer relationship management teams are using SaaS now due to this marriage of tech and trust.

Still, the SaaS world has remained divided into segments: a company would use one provider for SFA, another for closed loop marketing, yet another for sample accountability and distribution, and so on. Veeva Systems announced this week it’s developed an application network—Veeva Web—integrating its original-flavor system with ones from Exploria, QPharma, and TerrAlign in an attempt to create the Holy Grail of life-sciences SaaS. “We’re looking to eliminate the cost of system integration,” Wallach said.

That pharma mistrust hasn’t completely abated, though, and many companies are waiting to see if this is, in fact the Holy Grail, or if it’ll be another case of dashed hopes.

As the life sciences industry continues to grow in complexity, its commercial model is changing too. The traditional ’single message to many’ approach to delivering your product information has been re-focused to building and maintaining relationships to achieve lasting share of mind. Given the imperative to ‘do more with less’ your commercial organization may be re-evaluating the effectiveness of your Customer Relationship Management (CRM) system. What are the questions that you should be asking yourself and your vendor when considering a CRM investment? Please join us for a free live webcast, featuring a panel of industry experts who will share practical insights to help you define your organization?s current and future needs and determine what CRM capabilities are best suited meet them.

Register Free at http://pharmexec.com/yourcrm

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SK&A released the results of its latest physician survey, and it turns out that most docs are happy to meet with sales reps as long as they make an appointment in advance.

In fact, 98 percent of offices that allow sales reps to make office calls see 20 reps per week.

“That’s how many reps step through the door,” said Jack Schember, director of marketing, SK&A. “And by that we mean reps that were allowed in to drop off promotional materials, drug samples for signature, attempt to see the physician, or have an appointment for a meeting.”

Schember admits that SK&A has no benchmark to compare the data against, as this is the first time that company has asked the question as part of its Physician Access Survey, which surveyed more than 200,000 medical offices.

There is no data on how many of these sales calls are repeat visits from the same rep, or what companies they represent.

Of the physicians interviewed, 49.6 percent said that they require an appointment to meet with a rep. That’s up from 38.5 percent in 2008. Doctors in smaller practices appear to be the most likely to demand appointments, but they are also more likely to meet with reps, because they own the practice.

On the other hand, “doctors in larger practices are requiring appointments because their policies are governed by corporate owners, such as medical groups and health systems,” Schember said. “In some cases, pharma reps have to apply through the corporate owner for clearance to visit a single office.”

Physicians in specialties such as diagnostic radiology, pathology, and neuroradiology are the most likely to deny all access to reps, while diabetes specialists are the most likely to meet with a rep. Just make sure to schedule an appointment ahead of time.