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In a tight market, pharma companies are asking themselves: "How can we get more from scarce resources?" As a result, R&D and sales/marketing expenditures are under increased scrutiny-and they should be. Both areas consume significant resources (about 25 percent of revenues combined) have experienced rapid growth, and their results have been difficult to quantify. But to make the most of both human and non-human assets, management must first understand how those assets are currently allocated, how to make them more productive, and if there are better ways to deploy them. That substantial task will be further exacerbated as the industry

The main challenge for pharma companies this year will be to address public concerns about drug prices and access. Although recent bioterrorism fears raised demands for life-saving medicines, the public focus has shifted to the rise in pharmaceutical expenditures and its effect on healthcare costs and on efforts by insurers and government health agencies to limit pharmaceutical coverage.

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New Accord

For once, health activists and the pharma industry both welcomed a World Trade Organization declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and public health, but there is little doubt that it opens the way to further compulsory licensing and parallel imports.

State Action

MICHIGAN-In an aggressive move to squeeze price discounts from the industry, Michigan recently released a list of pharmaceuticals, mostly generic and lower-priced,

Washington, DC-With no signs that FDA plans to significantly limit direct-to-consumer advertising of prescription medicines, state governments across the country are proposing their own curbs. During the past year, legislators considered some 60 bills or resolutions concerning pharma marketing or advertising, and efforts are likely to increase as state policy makers link DTC advertising to rising drug expenditures.

No one can pinpoint the precise instant it happened, but the dull cloud of our universe suddenly cleared. About a half-billion years had gone by since the Big Bang, finally giving the condensing proto-stars and quasars enough time to sweep a veil of dust from the young cosmos. Their light then penetrated the darkness and, along with that of countless other spawning suns, has traveled the skies ever since.

When Disaster Strikes

Despite the near paralysis resulting from the events of September 11, many businesses that had operated from New York's World Trade Center needed to be up and running the next day.

Geneva, Switzerland-A Medecins sans Frontieres (Doctors without Borders) report claiming there is virtually no research into diseases that predominantly affect the poor is distorted and politically motivated, says Dr. Harvey Bale, director-general of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). He claims that medicines do exist to treat most of the more dangerous diseases affecting poor people, but in many cases they do not reach patients for reasons that are beyond control of the pharmaceutical industry.

Johannesburg, South Africa-GlaxoSmithKline announced in October that it had licensed Aspen Pharmacare to manufacture three AIDS products: Retrovir-AZT (zidovudine), Epivir-3TC (lamivudine), and Combivir (zidovudine/lamivudine). The products can be distributed only to the public, including the government, non-governmental organizations (NGOs), and charitable bodies accredited by the World Health Organization (WHO).

Washington, DC-More countries are hosting pharma's R&D efforts, creating a research environment ripe for abuses of patient safety because FDA cannot ensure the same protection in foreign trials as in domestic ones. A recent study by the US Health and Human Service's office of the inspector general (OIG) found that regions with less research experience-including Eastern Europe, Latin America, and East Asia-have become more desirable locations for US-based companies and contract research organizations' clinical trials. In fact, the number of countries producing data for FDA submissions jumped from 28 to 79 between 1989 and 1999. And that trend shows no

Tokyo, Japan-European pharma industry leaders have called for the opening of the Japanese market through measures to promote greater innovation there. The demand followed a European Federation of Pharmaceutical Industries and Associations' visit to Japan led by EFPIA president Jean-Frany}ois Dehecq, chairman and CEO of Sanofi-Synthelabo.

Washington, DC-Pharma companies suffered a significant setback last month when developing countries at the World Trade Organization meeting pushed through a declaration allowing nations to override patent laws to cope with health crises. Although industry officials insisted that the agreement would have little impact on profits, the language sets the stage for more competition from cheap generic products in much of the world.

Brussels, Belgium-Pfizer believes the dual pricing system it introduced in Spain complies with Spanish and European Union competition laws, but the European Commission isn't so sure. Competition policy commissioner Mario Monti says the EC will scrutinize Pfizer's pricing policy, which is intended to prevent parallel trade out of low-cost Spain.

London, UK-Insurance companies will be unable to use genetic test results to approve or deny claims for at least the next five years, following a new agreement between the British government and the Association of British Insurers. The move ensures that people can still get insurance coverage whether or not they have had a test.

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Precious Plasma

Transfusion centers used to throw plasma away as though it were extraneous liquid, keeping only the red blood cells. During World War II, researchers discovered that the fluid left over after the red cells had been spun free contained vital proteins, and biochemist Edwin Joseph Cohn developed a method for their large scale extraction. Over the years, the scrutiny of plasma produced many new proteins that could be processed and used as life-saving medical treatments for rare blood diseases like hemophilia. Plasma fractionation is now a $6.5-billion-a-year business and more than a million people receive plasma therapeutics annually.

Washington, DC-To improve FDA's ability to respond to terrorist attacks, acting commissioner Bernard Schwetz tapped Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), to establish a formal crisis management program for the agency. Woodcock moved to the commissioner's office in November to develop a program to better track and coordinate FDA responses to terrorism.

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The computing power of today's PC enables marketers to conduct analyses that were unthinkable just a few years ago, creating exciting new ways to approach and track promotion response. This article describes a novel approach that models promotion response at the individual physician level.

The Office of Inspector General for the United States Health and Human Services Administration plans to evaluate the extent of pharmaceutical sales representative gift-giving in 2002, according to its recently released "Fiscal Year 2002 Work Plan."

In response to recent anthrax attacks on the media and the U.S. Senate, U.S. Health and Human Services and West Haven, CT-based Bayer Corp. have reached an agreement for a significant new federal purchase of the antibiotic Cipro™ (ciprofloxacin) at a substantially lowered price. The antibiotic is expected to be available by the end of 2001 and would be used to supplement existing emergency stockpiles for use in the event of a bioterrorist attack.

The Internet has become a new meeting place for drug companies and doctors, according to the Physician Meeting and Event Audit from Newtown, PA-based Scott-Levin. From February through April 2001, Scott-Levin surveyed its PMEA panel every month to determine the extent of "e-event" activity. More than 3,100 physicians participated in the study; 39% indicated that they had been invited to at least one pharmaceutical company-sponsored event conducted via the Internet.

New medicines in the pipeline for Alzheimer's disease, osteoporosis, arthritis and Parkinson's disease are among the many promising treatments in development for diseases of aging, according to a new survey released by the Washington-based Pharmaceutical Research and Manufacturers of America.

Relatively small numbers of American physicians are using electronic records or prescribing, and the United States lags behind other English-speaking countries in this regard, according to a survey of physicians conducted by Rochester, NY-based Harris Interactive for the Harvard School of Public Health and the Commonwealth Fund's International Health Care Symposium in 2000. The survey found that the use of electronic systems is much more advanced in Britain, New Zealand and Australia than in the United States. The numbers for Canadian usage were low, however, similar to those in the United States.