Tuesday, March 20, 2012

Inside America’s Drug Shortage by Alice Park -TIME

Congress has launched several investigations of the drug shortage problem, and last year President Obama issued an executive order directing the FDA to expand its authority to police drug shortages, including requiring all manufacturers to notify the agency of impending shortages; currently the FDA can only compel companies to alert them if they are the sole maker of a drug they plan to discontinue.
The Obama administration also instructed the FDA to report any violations of the government’s price controls on generics, however, which some critics of the problems believe will serve only to inflame the problem, rather than resolve it.
Meanwhile, the nation’s drug supply is growing increasingly unstable, leaving an unprecedented number of patients vulnerable to lapses in care. “There’s little question that it has never been like this, not just with cancer drugs, but with drug shortages in general,” says Dr. Michael Link, president of the American Society of Clinical Oncology. “We have had shortages before, but they have been intermittent, and never anything as extensive both in terms of the breadth of drugs affected and the depths of shortages and how long they lasted.”
So, who’s right — the FDA or the industry? Or neither?

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