Sunday, February 14, 2016

AMA may urge requirement of early warning of drug shortages

The American Medical Association might urge the U.S. Food Administration to increase notification requirements for pharmaceutical manufacturers about impending drug shortages.

AMA may urge requirement of early warning of drug shortages

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The American Medical Association gathers in Chicago Saturday for its annual convention and its House of Delegates will consider an advisory committee report that suggests the doctors group urge the U.S. Food Administration to increase notification requirements for pharmaceutical manufacturers about impending drug shortages.

The advisory committee report recommends an addition to AMA policy that calls for a specific time frame requirement for early warnings on drug shortages, and asks the AMA to call for a comprehensive federal report that discusses the root causes of drug shortages, according to a spokesman.

The recommendation would need to be approved by delegates sometime between June 18-20.

The advisory committee's report says in part, "Drug shortages continue to represent a national concern, with sterile injectables comprising the most common type of shortage. The [American Society of Health-System Pharmacists] Drug Shortage Resource Center reported more than 220 shortages as of May 23, 2012. The most prominent causes continue to be manufacturing difficulties and regulatory compliance issues; corporate decision leading to product discontinuation; consolidation of the pharmaceutical industry; and raw, bulk, or active pharmaceutical ingredient shortage.

"According to the FDA, they have been able to mitigate more than 125 potential drug shortages since October 2011 through a combination of early warnings from manufacturers and the creation of expedited solutions. Ongoing negotiations over the 2012 Prescription Drug User Fee Act have afforded a platform to create some legislative and regulatory solutions to the drug shortage problem."

Staff Writer
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About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com or 215-854-4506.

David Sell Staff Writer
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