One infamous result of such oversight problems occurred in 2008, when Chinese manufacturers substituted a fake ingredient for the main one in a supply of the blood thinner heparin. The contaminated drug killed 81 people in the United States and sickened hundreds of others. The FDA never inspected the plants that manufactured the main ingredient.
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Hoping to prevent similar situations from happening again, Mylan Pharmaceuticals is helping to negotiate an agreement between the FDA and generic drug makers that would provide $299 million a year for inspections. That sum would come from fees paid by the manufacturers themselves.
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