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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Biologics Product Shortages Q&A

 

What is the FDA doing to address biologic product shortages?

 
The U.S. Food and Drug Administration (FDA) is committed to making sure that patients and health professionals have access to the drugs they need when they need them. FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. The agency works closely with manufacturers of drugs in short supply to help restore availability and reduce the impact of a shortage.
 
FDA can help to mitigate drug shortages in some cases by expediting review of new manufacturing sites, new suppliers, and specification changes, exercising regulatory discretion, asking other firms to increase production and improving notification by manufacturers. 
 
A review of FDA’s approach to drug product shortages can be found on FDA’s website at:
 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm275051.htm
 
What plans are in place to mitigate current and future biologic shortages?
 
To further enhance the notification by manufacturers, the FDA has issued draft guidance for industry on notifying the FDA of issues that may result in a prescription drug or biological product shortage.
 
The draft guidance provides recommendations to industry and explains why FDA should be notified, who should notify the agency, what information should be reported, when it should be reported, how to notify the agency and what FDA will do with the reported information. The draft guidance builds on FDA’s current work to ensure Americans have access to the medicine they need.
 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292426.pdf
 
What should consumers and healthcare professionals know?
 
Early notification of potential drug and biological product shortages is an essential tool in helping FDA work with drug manufacturers, hospitals, doctors, and patients to prevent or mitigate a shortage before it becomes a crisis. FDA and the Department of Justice are taking action to help reduce and prevent drug shortages, protect consumers, and prevent stockpiling and exorbitant pricing of drugs in shortage.