Pharmaceutical Executive-09-01-2007

"India, as a manufacturing hub, offers safe, effective, quality medicines, at the very best prices. Now, we are on our way to become a R&D hub." For Dilip Shah, General Secretary of the Indian Pharmaceutical Alliance (IPA), India is currently on its way to undertake one of the greatest transformations ever experienced within the pharmaceutical industry, although the excitement has been over 30 years in the making.

From pamphlets to posters to informational magazines, doctors' offices are teeming with direct-to-patient promotions, and patients are starting to overlook them. To cut through the clutter, one healthcare-technology company created a device that replaces the common intake clipboard with a digital pad that collects patient information and responds with branded information.

A study of doctors uncovers the hard facts behind what professional sales strategies work

Ever since Jeffrey Kindler rocked our world last December with the news that Pfizer was cutting its sales force by 10,000, we've been waiting for all the other behemoths' shoes to drop. While no precise domino effect has occurred, downsizing, particularly on the sales side, is very much pharma's strategy du jour.

The history of prescription drug laws is a complex mix of evolution and politics-in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills-the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)-would both continue existing programs and create new regulatory burdens.

This piece has nothing to do with the Blackstone Group or its CEO, Stephen A. Schwarzman. Well, maybe just a little.

For the sixth year in a row, Pharm Exec invites Professor Bill Trombetta of St. Joseph’s University to analyze the pharma industry's financial performance with a battery of business metrics, old and new. The highlights: Genentech pulls ahead of its longtime rival, Amgen. Forest delivers another strong performance, despite dropping revenue. Schering-Plough is building enterprise value. Biogen Idec racks up a stellar profit margin. And Merck? Well, Merck is back, baby. And the winner is…

The Association of the British Pharmaceutical Industry is challenging the UK government over the financial incentives being offered by the Department of Health (DH) to encourage doctors to switch patients from on-patent medicines to specific generic alternatives. ABPI believes the way the incentives are structured contravenes EU law-if pharma companies were to offer similar payments, they would be in serious trouble.

Many see Vioxx and Avandia as clear signs that the drug safety system has failed. As soon as reports of these drugs' adverse events began to flood the media, consumers-and Congress-demanded to know: "Why didn't we know sooner?"

Is the American Medical Association's (AMA) Prescribing Data Restriction Program (PDRP) the answer to physicians' privacy concerns, or will it just hamper the relationship between rep and doc? Observant LLC recently gauged reactions to the PDRP and doctors' expectancies of how this initiative affects physicians' practices and their relationships with pharmaceutical representatives. The findings suggest that the initiative may have paradoxical negative implications for physicians.

It's certainly not headline news that these are tough days for the pharmaceutical industry. More than $60 billion in revenue from blockbuster drugs will evaporate as these products go generic over the next five years, while the productivity of clinical development has hit a particularly rough patch. Even in the companies with relatively strong pipelines, many of the new treatments are biotech products acquired out of house. The expected authorization of biogenerics will squeeze profits only further.

Much has been said about the need and imperative for life science companies to comply with the various laws and regulations that govern our industry. More recently, state-level marketing laws have proliferated, adding new rules of the road and resulting in thousands of hours and millions of dollars for training, tracking, reporting, consulting, analysis, and support systems.

As expected, must-pass legislation to reauthorize the Prescription Drug User Fee Act (PDUFA IV) has provided a vehicle to renew numerous programs and to establish new policies to ensure the safe use of medications. The measure implements a user-fee agreement issued in January 2007 as well as a similar user-fee plan for medical devices. It also continues incentives for sponsors to study pediatric uses of drugs and devices and gives FDA authority to require postapproval studies. Manufacturers will have to disclose more information about ongoing clinical trials and research results and must revise product labels within a set time frame. There is more funding for FDA oversight of postmarket drug use and for agency information systems. And manufacturers of more risky medications will have to adopt a range of pharmacovigilance activities to ensure appropriate product use.

There is probably not a senior executive on the planet who, at one time or another, hasn't raised an eyebrow or two to express exasperation over "people problems." But just try to run the modern business corporation without them. Forget the Internet chatter about the peopleless workplace. There’s no substitute for the contribution people make to the bottom line.

For pharma marketers, understanding the on-demand opportunity starts with recognizing that customers are, in many ways, ahead of the industry

In this issue, a longtime contributor to this magazine, former FDA official, and generally thoughtful, knowledgeable person concludes his excellent three-part series on drug safety with a look at how risk is communicated to patients and doctors. It's a fine, detailed, subtle piece of work, and I recommend it to you. (See "Failure to Communicate".)

That was the collective vow sworn by Big Pharma last December following Pfizer's $1 billion–down–the–tubes withdrawal of the cholesterol compound they had touted as the most important drug of the decade. The question is, What's the right organizational construct to support innovation-or at least to stop Phase III failures?

here's a solid case to be made for choosing A. The market for deals has been robust through the first half of 2007. A Cowen research report counted 10 public deals done by July 2007, compared with 14 for all of 2006. Another data source, Irving Levin Associates, cites 455 public and private healthcare deals in the first six months of 2007, a 12 percent decrease from the same period last year-but an 18 percent rise in deal value.

It's testimony to the high anxiety-and hectic activity-in the industry that the merger of German chemicals-to-pharmaceuticals firm Merck KGaA and Swiss biotech Serono elicited only faint fanfare. Both family-owned drugmakers boast an illustrious heritage, but their union garnered none of the pomp and circumstance befitting a marriage of European royalty.

If it looks too good to be true.... The price is unbeatable, the Web site proudly displays an accreditation seal of approval, medicines are advertised as "generics" of the branded versions (implying bioequivalence with respect to safety and efficacy), and patients never have to leave their homes. Marcia Bergeron, a 57-year-old Canadian resident likely had these things in mind when she purchased antianxiety and sedative medication from an online pharmacy. The pills she received from the Web site, however, caused hair loss and vision problems, and ultimately resulted in her death. The coroner's toxicology report showed that the pills she purchased online were laced with traces of dangerous metals, including uranium, strontium, selenium, aluminum, and arsenic. Bergeron, like many others around the world, was a victim of the counterfeit-medicine business, an industry that the US-based Center for Medicine in the Public Interest (CMPI) predicts will reach $75 billion in sales globally by 2010.