"At this time last year, we were on a pace of about one new shortage per day. Thanks to FDA's hard work, that pace is cut in half for this first part of 2012, when we have counted 27 new shortages" in nearly two months, Fox said.
The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.
In addition, consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity. That means when one manufacturer suddenly stops production, the small number of others making a drug can't quickly pick up slack.
The inability to get crucial medicines has disrupted not only carefully timed chemotherapy regimens, but surgery and care for patients with infections, pain and other serious conditions.
Meanwhile, some unscrupulous smaller distributors, dubbed "gray marketers," have been exacerbating shortages by charging hospitals many times the normal price for drugs that can't be acquired through normal suppliers. Several bills in Congress are pending that would establish penalties for drugmakers that don't give notice of impending shortages, or by setting penalties for price gouging on prescription drugs.
Of late, the cancer drug shortages have attracted the most attention, partly because missing multiple treatments can sharply reduce the chances of curing the disease. In the case of methotrexate, its use as part of the treatment for acute lymphoblastic lymphoma results in nearly 90 percent of children being cured, so parents and doctors were particularly upset at the prospect of it not being available.
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma
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