Schering-Plough Company

Financial resources for the colloquium were provided by the Academy and supplemented by contributions from a number of industries (American Cyana-mid Company, E. I. DuPont de Nemours Co., Givaudan-Roure Corporation, Merck Co., Monsanto, Rohm and Haas Company, Schering-Plough Research Institute, Sterling-Winthrop Inc., Syntex, Takasago International Corporation, Zeneca Inc.), to which we are much indebted. 

Phase III clinical studies completed NDA submitted February 2006 Company Toyama, Schering-Plough M.W. 426.41 (parent)... 

June 19 Four companies, Johnson Johnson, Pfizer, Merck, and Schering-Plough, agree to a six-month moratorium on advertising of new drugs and to modify payment of celebrities and experts who endorse their products. 

March 9 Merck and Schering-Plough announce a merger, making the combined company one of the largest pharmaceutical companies in the world. Merck pays 41.1 billion for the smaller company. 

If the drug is a new formulation of an existing blockbuster, the company may want to tie the name as much as possible to the predecessor. That s obviously what Schering-Plough was trying when it came out with Clarinex just as Claritin was about to lose its patent protection. 

Figure 2 Sum of annual R D spending by six large pharmaceutical companies in the United States Pfizer, Merck, Eli Lilly, Bristol-Myers Squibb, American Home Products (renamed Wyeth in 2002), and Schering-Plough. These companies are listed in descending order of the total amount of their profit spent on R D. In terms of R D investment in 2000 as of percentage of sales that year, the order of the companies changes to Eli Lilly (19%), Pfizer (15%), Schering-Plough (14%), American Home Products (13%), Bristol-Myers Squibb (11%), and Merck (6%). On average, these companies spent almost 12% of their 2000 sales on R D. Data from Ref. 8.

While the Abbott incident did not directly involve computer systems validation, persistent computer systems validation noncompliance should be regarded just as seriously. Other pharmaceutical manufacturing companies such as Wyeth-Ayerst, Johnson Johnson, and Schering-Plough have found to their detriment that persistent noncompliance can result in a most unpleasant outcome. Initial fines by the FDA on behalf of the U.S. Government have ranged from 30 to 575 million with ultimate costs as high as 1.5 billion (typically 16 to 24% of sales revenue). Senior executives have been identified as individual defendants in U.S. prosecutions. Beware that contempt of the law in the form of GxP practices does not threaten your business ... 

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