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FDA disputes report alleging role in drug shortages
Modern Healthcare

The Food and Drug Administration is taking issue with a House committee report released in June that attributed the cause of drug shortages to the agency’s regulatory and enforcement actions. In a July 23 letter, the FDA said it is not the “root cause” of drug shortages. Instead, the agency said that manufacturing and production problems, such as quality-related issues and delays, business decisions to discontinue some products, increased demand, loss of manufacturing sites, and difficulty obtaining raw materials have caused the shortages.