Thursday, June 14, 2012

Shortages of Generic Sterile Injectable Drugs: Diagnosis and Solutions

According to the U.S. Food and Drug Administration, the number of times that sterile injectable drugs were in short supply almost tripled from 61 in 2005 to 178 in 2010. The figure reached more than 250 in 2011.

Although the problem is complex, the possible causes can be categorized as supply-side or demand-side. But which dominates?

Supply-side factors include physical constraints due to remarkably high standards in the chain of production and in the distribution of these potentially very dangerous products. Similar constraints apply to the acquisition of the drugs’ active ingredients. Another key supply-side factor is an unproductive FDA, which has increased its regulatory burden on current suppliers and made it very difficult to get approval for new generic medicines and manufacturing facilities.

Potential demand-side factors would include government-dictated rebates or discounts for programs such as Medicare, Medicaid, and the 340B program for safety-net hospitals and clinics.

Currently proposed solutions are unlikely to address the crisis satisfactorily. Congress appears ready to give more power to the FDA - but the real solutions lie in giving more choice to patients and physicians.

Read the entire study, published by the Mackinac Center, at this link.

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