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| US drugmakers face the fire over lax manufacturing practices Posted: 30 Jun 2010 10:27 AM PDT
Most recently, Johnson & Johnson‘s McNeil Consumer Healthcare unit has had to cease production at a Pennsylvania plant that supplied a number of brand name over-the-counter medications including Tylenol, Motrin, and Benedryl. As the FDA investigated, McNeil halted manufacturing operations at the location after potential contamination issues came to light and prompted a recall of several children’s liquid medications. A recent update suggests that production at the J&J plant won’t resume until 2011, as a number of process improvements and upgrades are required for the plant to regain compliance. While consumers can readily access alternative products or generic versions of the popular cold remedies, the lack of selection is easily apparent on store shelves. And while prosperous J&J won’t suffer much financially from decreased sales of the products, the company will have to work to re-establish its good old boy reputation with US consumers. Another US drugmaker, biotechnology firm Genzyme, has also experienced contamination troubles at one of its US manufacturing plants in the past year, but in this case the closure of the plant caused a widespread shortage of its hard-to-produce rare disease therapies, wreaking havoc on patients who depend on the drugs and putting a dent in the company’s bottom line. Genzyme is feeling ripple effects from its inability to regain full production, such as shareholder dissent and increased competition from rivals elbowing their way into the company’s near-exclusive market. The FDA appears to be making good on its promise to crack down harder on US drug manufacturers, as well as foreign importers, not only in the area of good manufacturing practices but also in regards to marketing, sales, and research and development tactics pursued by the industry’s players. Hopefully the agency’s actions will cause more companies to take a closer look at their own operations before contamination issues, recalls, and shortages bring ill effects upon the consumer market. ~ Photo by Justin Lai, used under a Creative Commons license. |
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