Drugs: Costs and ControlsDrug shortages, drug costs, the questionable quality of over-the-counter medicines: myriad issues have developed in pharmaceuticals in an era of enhanced regulatory efforts, rising healthcare costs and a global economy in which drug components are manufactured around the world. The new war on drugs is a policymaking battle in the legislative arena not over illicit back-alley dealing, but over cost, control and accessibility of the pills populating Americans' medicine cabinets.
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There seems to be a surprisingly pervasive belief that drug companies aren't working on cures for disease because it's far more profitable to chronically maintain patients on medication.
Drug companies -- at least every one that I've worked with -- would like to develop important new medicines that improve health and save lives. That's what gets every industry researcher I know up in the morning, and what keeps them going through the many highs and lows that characterize the scientific process.
Poorly manufactured and fraudulent medicines kill thousands of people around the world each year. For infectious diseases like malaria and HIV, shoddy medicines also accelerate drug resistance and dramatically alter the course of epidemics. With few new drugs under development, recent progress against these major killers in the poorest countries is precarious.
India's Supreme Court rejected a patent for Glivec, Novartis's blockbuster leukemia drug, putting an end to a seven-year legal battle. This decision threatens the health of patients in both India and the US.
AstraZeneca's revitalization strategy, announced this week, follows the same playbook used by so many in the industry, employing approaches vividly familiar from my consulting days: cut headcount, externalize R&D, focus on select therapeutic areas, push biologics, and explore an interesting flyer.
The announcement last night that Affymax (NASDAQ: AFFY) is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward.
According to the US Food and Drug Administration, pharmaceutical companies in developing countries such as India are increasingly falsifying data about the quality of their medicines. One solution to this quality control dilemma is to enact sanctions against companies that fail to provide quality products.









