Making Pills The Smart Way
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Despite its high-tech image, the pharmaceutical industry is less adept at manufacturing than you might expect. One recent horror story was Schering-Plough Corp.’s (SGP ) slip-up on asthma inhalers. In 1999 and 2000, the company recalled 59 million units because it couldn’t prove that the inhalers contained the active ingredient. The Food & Drug Administration, meanwhile, has found hundreds of quality violations at other companies. The woes are a symptom of a deeper problem: factory processes so antiquated that companies typically can’t even pinpoint the causes of snafus. “Manufacturing has been the poor stepchild of the pharmaceutical industry,” says Jeffrey T. Macher of Georgetown University’s McDonough School of Business. Now, that stepchild is getting the attention it deserves. Macher and his colleague Jackson A. Nickerson of Washington University’s Olin School of Business are leading an effort to find and correct flaws in drug-manufacturing practices and in FDA regulations. The FDA itself is altering its rules, hoping to foster more innovation in factories. And companies such as Pfizer Inc. (PFE ) and Abbott Laboratories (ABT ) are spending tens of millions a year to install new technology and processes in plants. The potential economic gains of a quality boost are huge: “Everyone has said that costs could decline by up to 50%,” Nickerson says. That would save scores of billions of dollars. The new approach would also make manufacturing more flexible, making it easier for companies to produce the personalized treatments that are expected to become common in the future More : businessweek.com |