over-the-counter medicines and animal health drugs. In announcing the closure, Novartis noted that combined annual sales of the products made at the facility amount to less than 2 percent of Novartis group sales overall. But the unfolding drama which includes a scathing report issued last summer by FDA inspectors may hurt more than the drugmaker would care to admit. In fact, one Wall Street analyst projects that lost sales could amount to $560 million over the next 12 months. Leerink Swanns Seamus Fernandez calculates in an investor note that the missed opportunity to sell such stand-bys as Excedrin, Bufferin and No-Doz represent about 25 percent of US consumer sales, or about $390 million, not including another $170 million in incremental sales, assuming the shutdown lasts only three months.However, this does not include lost sales of animal health meds, such as the big-selling Interceptor and Sentinel treatments for heartworm, or apparently contract manufacturing. Endo Pharmaceuticals, for instance, reported that prescription painkillers made at the facility wound up in some bottles for other meds, although it remains unclear if these were OTC or prescription.And of course, the shutdown might well last much longer.The drugmaker, he notes, expects to meet with the FDA later this month, giving Novartis execs an opportunity toprovide in time for the next earnings announcement. Nonetheless, he notes that the suspension has the potential to affect up to $1.1 billion in global sales. History suggests that few (manufacturing) challenges resolve quickly, but a partial resumption of (manufacturing) is certainly possible, although a resumption of manufacturing and a full recovery in the recalled brands are likely to take considerably longer to resolve, particularly given the FDAs involvement, he then adds.At this point, whether Novartis can avoid a lengthy shutdown is very unclear. The problems the FDA cited in the inspection report were so disturbing that the agency used capital letters and a bold font to emphasize that a pattern of problems existed. These problems included failures to respond to consumer complaints about bottles containing incorrect tablets, file reports with the FDA or send postage-paid materials to consumers so that further evidence could be examined.The drugmaker did not help it cause by insisting the problems were beyond its control, even though the FDA noted plant personnel failed to properly investigate many complaints and could not present any evidence to justify its conclusion. Moreover, the shutdown and subsequent recall came shortly after the FDA sent a warning letter to Novartis about manufacturing problems at three plants run by its Sandoz generic drug unit. Its hard to avoid the conclusion that the FDA is searching for system issues and still other plants are going to be scrutinized.The worst-case scenario is, in fact, a lengthy shutdown and possibly still more, depending upon how the FDA proceeds. Then there is the prospect of a consent decree. Remember that the FDA has pursued this step recently with Johnson & Johnson and Genzyme, and Wall Street is speculating that Hospira is up next. No one has suggested it may come to this, but the sort of problems that Novartis