Pharmaceutical Economics and Policy

--- ...since its publication in 1997, for during the interval we've had (among other developments): (1) The Food and Drug Administration Modernization Act (FDAMA '97), (2) The promulgation of the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals (2002), and (3) The federal Department of Health and Human Services (DHHS) formally weighing in with their final "anti-kickback" guidance from the Office of their Inspector General (OIG), incidentally shutting the door between pharmaceuticals marketing and the drug manufacturers' "support" of continuing medical education (CME) on April 28, 2003. (4) New concerns regarding drug safety issues (both pre- and post-marketing) have been raised by way of the COX-2 NSAID crisis, particularly by Merck's defalcations in the suppression of adverse events data in the 2000 publication of their VIGOR trial results (see Waxman's editorial in *The New England Journal of Medicine*, June 23, 2005;352[25]:2576-2578), and have invoked structural and procedural changes in the FDA's Office of New Drugs (OND) the end of which is not yet in sight. (5) Medicare Part "D" has gone into effect, with NICE long-term implications for future impact upon the pharmaceutical industry in these United States. Things have *changed,* folks. There's ten years' worth of critically important regulatory and pharmacoeconomic changes that neither the author nor the rest of the industry could have taken into consideration back when the galleys of this book were returned to the publisher. To the best of my knowledge, there is still no other source of information on the subject as ambitious (and as competently written) as is Dr. Schweitzer's work. Both author and publisher must certainly be aware of the fact that there is a need (and a definite market) for a new edition. ---

I believe the book is useful for everyone in The Pharmaceutical Industry. It will be useful for reps, higher management, physicians, technicians, scientists, product and regulatory affairs managers and just about anyone who wants to "think outside the box" of their specific role within the industry. Despite its broad range the book is succinct, never vague, and contains a plethora of useful information. I came across this book without never having heard about the author and with the sole purpose of finding specific economic data. I found that and much more. What an astonishing surprise the book was. The book presents the most comprehensive and intelligently condensed information about the overall pharmaceutical market forces, that I saw recently. specific to the industry. For instance, the short Chapter (2) on marketing Pharmaceuticals offers more important data and contextual information than most books entirely dedicated to Pharmaceutical marketing. In a little more than 20 pages the author manages to provide useful information about sales forces management and economic analysis, including joint marketing, along with definitions about all types of promotional materials and relevant organizations for promotion of Pharmaceuticals, including Continuing Medical Education and the FDA's Division of Marketing. In the even shorter chapter on pricing, the author starts by cleverly laying out the fundamentals of supply and demand for Pharmaceuticals and goes on to quantitatively and contextually explain the worldwide differences. Overall the book has information just about any Pharmaceutical market topic; from all of the non-life sciences issues associated with pre-clinical development of drugs to the structure and future trends of the industry. All this information is easy to find because the book is simply organized in internal analysis (the industry) versus external analysis (consumer, market, public and private influential institutions). I'm truly impressed with the depth and range of knowledge displayed in this book, so much so that if I wasn't working for The Pharmaceutical Industry already I would approach Professor Schweitzer for a postdoctoral research.