Information About Drug Shortages
It is FDA's policy to help prevent or alleviate shortages of medically necessary drug products. A
drug shortage may involve either an actual or a potential shortage of a drug product. Drug
shortages occur for a variety of reasons including manufacturing difficulties, bulk supplier
problems, corporate decisions to discontinue drugs, and FDA enforcement actions. These drug
shortages can have significant public health consequences. More...
When A Drug Is In Short Supply
Potential drug shortages are a top agency priority, according to Mark Lynch, a branch chief in FDA's division of drug manufacturing and product quality. "Shortages call for rapid communication among the key people within FDA," he says. "Those involved have to drop what they're doing and react rapidly to the crisis."
But a reduction in the drug supply doesn't always warrant this emergency status. To be defined as a high-priority drug shortage, the drug must be found to be "medically necessary.".
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Claritin Patent Fight A Hot Political Issue
ABC News reported last week that Senate leaders are allowing drug maker Schering-Plough
to insert a special-interest provision in
congressional spending bills that will protect its
$5 million per day market for the allergy drug
Claritin. The provision will cost consumers $11
billion, according to the University of Minnesota
College of Pharmacy.
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