LYCOS RETRIEVER 
Claritin: Schering-Plough
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The action against Schering-Plough, maker of Claritin and one of the nation's top 10 pharmaceutical companies, is unusual in its size but consistent with the FDA's growing concerns over questionable manufacturing practices. Since the FDA won the authority in 1999 to go after the profits of companies that do not comply with federal good-manufacturing rules, the agency has reached similar though smaller settlements with several other companies.
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The biggest drag on the sector is Schering-Plough, which last year lost patent protection for Claritin, the allergy medicine, and faces increased competition for its hepatitis C treatment. Recently, the Kenilworth drug maker announced a restructuring.
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Claritin is dead as a major driver of sales growth for Schering-Plough. But now the Kenilworth, N.J.-based drugmaker says it will try to conserve a fraction of Claritin sales by switching the drug to over-the-counter status itself--perhaps getting another three years of marketing exclusivity in the process.
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In April 2002, the European Medicines Evaluation Agency (EMEA) announced it was conducting a safety review of the drug after receiving an alarming number of reports from Sweden of birth defects in children born to mothers who used Claritin while pregnant. A spokesperson for the agency said an investigation would likely last several months. Officials with Schering-Plough say the cases simply "constitute random events".
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With prescription drug costs rising quickly, one insurer is already pressing regulators to ... make a successor of Claritin available over the counter. Wellpoint, the large California insurer that prompted the Food and Drug Administration's evaluation of Claritin, has also asked the agency to make Clarinex, Schering-Plough's newest allergy drug, available over the counter. Insurance companies typically do not cover the cost of nonprescription drugs.
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