In a recent letter to the House Committee on Oversight and Government Reform, the FDA responded to a June report in which the committee claimed FDA regulatory and enforcement actions have been largely to blame for some drug shortages.
The FDA says just the opposite: that it’s doing all it can to curb shortages.
“By working closely with manufacturers experiencing problems, as well as potential alternative manufacturers, and by exercising regulatory flexibility to help mitigate shortages, FDA has had a substantial positive impact on the shortage situation,” the FDA writes in its letter.
The House committee report FDA’s Contribution to the Drug Shortage Crisis found that FDA prodding forced companies producing generic injectable drugs to take manufacturing off-line. The report concluded that facilities at four top American pharmaceutical companies are operating at 30 percent less capacity because of FDA regulation.
As of February 2012, more than 200 drugs, including 26 oncology drugs, appeared on the American Society of Health System Pharmacists’ drug shortage list.
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