Wednesday, April 11, 2012

When central planning strikes

Our government caused drug shortage

The Washington Post on the nation's growing drug shortage problem today:

Shortages of prescription drugs have been a growing concern for the past six years. They nearly tripled from 2005 to 2010 and reached record levels in 2011 as manufacturers ceased operations or ran into production problems. ... In some cases, lifesaving treatments have been delayed, sending patients on desperate searches for needed medicines, doctors say. Shortages have also caused injuries from mistakes and at least 15 deaths around the country since mid-2011, according to the Institute for Safe Medication Practices, a nonprofit that tracks medication errors.
Last year, nearly half of hospitals reported experiencing a drug shortage on a daily basis, according to a survey of 820 hospitals by the American Hospital Association. About 82 percent of hospitals said they delayed treatment because of a shortage, and 35 percent of hospitals said patients experienced “adverse outcomes.” The survey did not categorize those outcomes, a spokeswoman said.

So why are these shortages happening? The Post doesn't begin to try and explain why until the 26th paragraph when they report, "A number of complex factors are contributing to the shortage, experts said." But as John Goodman explains at theHealth Affairs Blog, the FDA is the main source of the problem:

The Federal Food and Drug Administration (FDA) has been stepping up its quality enforcement efforts — levying fines and forcing manufacturers to retool their facilities both here and abroad. Not only has this more rigorous regulatory oversight slowed down production, the FDA’s “zero tolerance” regime is forcing manufacturers to abide by rules that are rigid, inflexible and unforgiving. For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

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