Record Drug Shortages Plagued the Year Gone By

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A year-end tally of U.S. prescription drug shortages shows a 27% jump in the number of recorded shortfalls, but a new FDA rule and proposed legislation offer some hope for progress.

This article published with permission from The Burrill Report.

A year-end tally of U.S. prescription drug shortages shows a 27% jump in the number of recorded shortfalls, impacting a broad array of medical needs.

There were 267 new shortages tallied by the University of Utah Drug Information Service during 2011, up from 211 cases recorded last year. The number of shortages hitting common classes of medicines, including CNS, antibiotic, and chemotherapy drugs has more than doubled since five years ago, when the service found just 129 shortages.

The problem is impacting not just branded medications, but generics too, including crucial drugs used during surgeries, leading in some cases to the postponement of planned procedures. An analysis by the Premier healthcare alliance in March 2011 found that more than 400 varieties of generic drugs were back-ordered for five or more days from July 1 to December 31 in 2010.

Consumers, medical professionals, Congress, and even President Barack Obama have all expressed concern about the problem. Following analyses from multiple groups, Obama in November ordered the U.S. Food and Drug Administration to step up efforts to curb prescription drug shortages. A new FDA rule broadening the circumstances under which some companies making critical drugs must alert the agency to plans to halt production will go into effect January 18.

wo bills that would establish monetary penalties for failure by drug makers to notify the FDA of plans to discontinue or interrupt the manufacture of prescription drugs are under consideration. Senate bill 296 has been referred to the Senate Health, Education, Labor, and Pensions committee, while House bill 2245 has been referred to the House Energy and Commerce, Subcommittee on Health for further action.