General Articles

This letter concerns the FDA press release dated January 18, 2006, entitled "FDA Announces New Prescription Drug Information Format to Improve Patient Safety." The information contained is considered false and misleading, and lacking in fair balance.

The headline states that this new label format will improve patient safety. In addition, a quote from HHS Secretary Mike Leavitt says the new format "will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare." We are unaware of any substantial evidence that measures use of drugs or drug outcomes related to the new format.

Pharma companies need to better manage their marketing and sales spend directed at healthcare professionals. Five states have already mandated that drug companies track, control, and report this data, and many more states have legislation pending with distinct requirements. These new reporting mandates will hold companies accountable for documenting their interactions with healthcare professionals. Companies that don't track this data will see the repercussions—from fines of up to $10,000 or injunctions on their products. While companies should start to change their methods of reporting, many are ill prepared for state-by-state compliance mandates. This article discusses how pharmaceutical companies can address these laws by collecting better and cleaner data from their reps.

Streamline Data Collection

For years, educational institutions have enjoyed their own Internet domain: .edu. US governmental agencies have .gov, and non-profits have been able to set themselves apart from the crowd with .org in their e-mail and Web addresses. Thanks to changes made to the Internet's Domain Name System (DNS) in 2001, subject-specific vertical segments have been able to flee the .com world for newly established domains, such as .travel, .jobs, .museum, and .info.

Subject-specific domain names have many advantages. Internet addresses are proliferating: Domain registration in the .com and .net domains topped 50 million in 2005, according to Zooknic, a project that tracks use

Doctors don't respond well to the traditional sales and marketing push. But, they do respond well to each other. In fact, there are doctors who wield tremendous power of persuasion over their peers. These doctors have earned the respect and attention of other prescribers and have been recognized for their expertise and knowledge of innovative, emerging therapies. But more important, they are likely to try, adopt, and advocate for new products.

Jerry Maynor

Dtc ads often don't teach consumers how to tackle their health issues. They may disseminate information, but they don't tell consumers how to act on that information. Jill Balderson, vice president of strategic marketing services at HealthEd, says consumers deserve more education and less promotion from pharma marketers. "Sometimes the most valuable and useful information—such as how to use the product—gets muddled in a promotional message," she says. "Education means giving patients information they need to know in order to see a positive outcome." She says that traditional patient materials lack the clarity and specificity that consumers need to learn about a disease or illness, let alone follow the medication's directions. But, Balderson believes times are changing. "Marketers are starting to realize that consumers need information they can not only understand but use," she says.

Before a pharmaceutical company dispatches a sales rep to a medical practice, the marketing department learns some basic facts about the physician: how many new prescriptions she's written, how many refills, and how much upside prescribing growth she might generate. What the rep usually doesn't know: who else—nurse practitioners and physician assistants—prescribes medications in the office, at a nearby clinic, or sometimes in a separate practice just down the hall. The rep could make another sales call, but for a variety of reasons he usually does not. Physician assistants and nurse practitioners remain poorly recognized, and therefore rarely courted by pharma. One barrier to marketing to these clinicians is simple lack of prescribing data. Information offered for sale by the big data providers frequently excludes nurse practitioners and physician assistants. And in the pharmaceutical industry, where there is no data, there is no marketing.

After almost two decades of blockbuster-driven prosperity, the model for success in pharmaceuticals has broken down. Growth and profitability have declined across the board. In fact, the sector as a whole has created no value in the past five years. The sources of this stagnation are many: higher development costs, declining R&D productivity, increased competition for in-licensing, higher marketing costs, generics, pricing pressure, and increased political and regulatory scrutiny. The path forward, once clear, is no longer obvious.

Segmenting Disease Areas

You never listen to me." "The workload around here isn't equal." "You made that decision without consulting me." "We never really deal with our conflicts." "You're not taking my needs into consideration." Those comments sound like complaints from people in a troubled marriage, but the partners in this relationship are companies, and it's their corporate alliance that is failing. With strategic alliances becoming the US pharma industry's "mode of operation"-the number grew from 121 in 1986 to 712 in 1998-it is critical that companies learn good partnership skills. This article describes methods developed by Procter & Gamble Pharmaceuticals (P&GP) that can help companies assess the health of their corporate relationships and avoid becoming another corporate divorce statistic.

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When President Bush commissioned the biotechnology industry to step up its biological warfare defense efforts, few could have predicted the level of commitment that would follow. n Since the September 11 terrorist attacks o­n New York and Washington, D.C., the number of companies enlisted in the fight against bioterrorism has grown exponentially, with pharmaceutical companies offering federal agencies a range of services from drug donations and broad-based technical expertise to cutting-edge products that show promise in eradicating emerging public health threats. n "The biotechnology industry is doing a great deal to battle [bioterrorism], and is very committed to promoting and protecting public health and national security," says Brent Erickson, a spokesman for the Biotechnology Industry Organization, Washington.

By Helicia Herman WHO WORLD HEALTH REPORT 2004 The WHO (World Health Organisation) World Health Report 2004 focuses exclusively o­n HIV/AIDS and is subtitled “Changing History.” It argues that the fight against AIDS has reached a critical moment and that the possibility now exists, with the help of drugs, to alter the course of the epidemic. WHO General Director Jong Wook Lee commented: “This is a historic opportunity, and we cannot let it pass us by. Future generations will judge our era in large measure by how we reacted to the AIDS epidemic.”

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