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Drug Shortages – Is It Time For The Federal Government To Produce Generic Drugs?
Recently, there has been widespread media coverage of nationwide drug shortages involving a significant number of commonly used pharmaceuticals, ranging from drugs routinely used in the operating room, to medications used to treat bleeding disorders, neurological, and psychological disorders, as well as cancer. As a hematologist/medical oncologist, I have been particularly disturbed by the widespread and prolonged unavailability of commonly used chemotherapy and support drugs.
American Medical News (amed.com/government) recently reported that, according to the American Society of Health-System Pharmacists, there is currently a national shortage of over 200 drugs. Updates on the status of these drugs are available on the following websites: www.ashp.org (The American Society of Health-System Pharmacists) or www.fda.gov (The Food and Drug Administration). These sites provide information about which drugs are in short supply, the reason for the shortage, and, possibly, an estimated release date. Updates are noted; daily updates from the FDA will be provided upon request.
There is no question that a large number of important pharmaceutical agents are in critically short supply. It is also quite clear that many of the drugs that have been difficult to obtain are generic drugs that have been around for years.
On April 18, 2012, the House Energy and Commerce Health Subcommittee began holding hearings on the issue. A major point of discussion during these hearings was the reauthorization of The Prescription Drug User Fee Act (PDUFA), which was a law passed by the United States Congress in 1992 allowing the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. This was discussed as a potential solution to the current, ongoing problem of pharmaceutical drug shortages.
It is my opinion that if the domestic pharmaceutical industry, in cooperation with the FDA, cannot improve the ongoing situation with drug shortages, the federal government should strongly consider manufacturing, distributing, and selling these pharmaceuticals itself. It is also my strong opinion that we should not rely on foreign-produced pharmaceuticals due to concerns regarding drug pedigree, quality control, and drug counterfeiting. The lack of available generic drugs also places a financial strain on our already stressed national health system. In addition, this drug shortage poses a real threat to our national security if we are unable to assure a dependable, safe supply of pharmaceuticals for the United States.
This article was submitted by Dr. Steve Mamus of the Cancer Center of Sarasota-Manatee. Please contact us for more information.