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Obama pushes FDA and drugmakers to solve shortages

02-Nov-2011
Last updated the 02-Nov-2011 at 14:10 GMT

US President Barack Obama has leaned on the US FDA to ramp up its early warning system for drug shortages and asked manufacturers to do more.

Earlier this week President Obama issued an executive order designed to boost the FDA's ability to report potential drug shortages by providing additional staff and resources that accelerate reviews of manufacturing plants and suppliers.

The order also requires that the FDA gives the Justice Department more information about possible instances of collusion or price gouging.

Congress has been trying since February to do something about this. It has not yet been able to get it done. It is the belief of this administration that ... we can't wait," Obama said after unveiling the plan.

Drug shortages have been a major problem for the US for some time with, according to the latest data, 178 vital medical products being in short supply in 2010.

The leading reasons for the reported shortages were problems at the manufacturing facility (43 per cent), delays in manufacturing or shipping (15 per cent), and active pharmaceutical ingredient shortages (10 per cent).

In light of this analysis the Obama Administration also sent drug manufacturers a letter reminding them of their obligation to report the discontinuation of certain drugs to the FDA and encouraging companies to voluntarily disclose to the agency potential shortages in cases where disclosure is not currently required by law.

FDA commissioner Margaret Hamburg said: “We can make a very real and meaningful difference by expanding our network of early warnings.”

PhRMA (pharmaceutical manufacturers association) CEO John Castellani welcomed the move, but injected a note of caution.

“The implementation of the President’s executive order must effectively strike a balance between addressing a complex set of rare but nevertheless concerning issues in the manufacturing process while promoting a market environment that fosters accessibility for these needed products.”

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