Reducing Prescription Drug Shortages
Nov 3, 2011
Signed by: Barack Obama
Signed on: Oct 31, 2011
Published on: Nov 3, 2011
Nov 3, 2011
Signed by: Barack Obama
Signed on: Oct 31, 2011
Published on: Nov 3, 2011
Summary
Tells the FDA to work with drug makers to report, prevent, and lessen shortages of important medicines that save lives.
What problem does this solve?
The number of shortages for life-saving drugs has been growing, putting patients at risk. This order helps the FDA get early warnings about potential shortages and stop companies from unfairly raising prices.
What does this order do?
Mandates broader reporting of drug discontinuances
Requires the FDA to use its authority to make drug manufacturers provide advance notice when they stop making drugs that are life-supporting or prevent serious disease.
Speeds up regulatory reviews
Directs the FDA to expedite its review of new drug suppliers and manufacturing changes when doing so would help avoid or lessen a drug shortage.
Reports price gouging to the Department of Justice
Instructs the FDA to tell the Department of Justice about any market participants found to be hoarding drugs or selling them at excessively high prices during a shortage.
Who does this affect?
- Patients requiring critical medications
- Pharmaceutical manufacturers
- Healthcare providers
What is the real world impact?
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Protects public health
Aims to prevent shortages of critical medicines like cancer treatments and anesthesia drugs, which pose a serious threat to patient safety.
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Increases oversight of drug manufacturers
Requires drug companies to give the government early warnings about potential supply problems, adding a new layer of reporting responsibility.
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Cracks down on price gouging
Directs the Department of Justice to investigate and take action against companies or individuals who hoard scarce drugs or sell them at extremely high prices during a shortage.
When does this start?
The actions directed in this order became effective on October 31, 2011.