Pharmaceutical Executive-12-01-2001

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.

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.

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.

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.

Calls for change reflect that generic products are a therapeutic mainstay and that patients and providers want earlier access to inexpensive medicines.