Health and social policy

Executive Order 13588: Reducing Prescription Drug Shortages

President: Barack Obama

Directed FDA to press manufacturers for early shortage notices expedite reviews and examine enforcement discretion.

Status: In effect. Is Executive Order 13588 still in effect? Yes. Executive Order 13588 remains in effect. See Federal Register record.

What does Executive Order 13588 do?

EO 13588 addressed growing shortages by directing FDA to use existing authority for early manufacturer notification, expedited regulatory review and carefully weighed enforcement responses. Congress then strengthened and expanded mandatory discontinuance and interruption reporting in the 2012 Food and Drug Administration Safety and Innovation Act. FDA continues maintaining shortage lists and working with manufacturers under those statutory duties.

Administration position: FDA can mitigate shortages but cannot guarantee supply, excuse unsafe manufacturing or compel production without statutory authority.
SignedOctober 31, 2011
LeadFood and Drug Administration
Core toolEarly manufacturer notification

Before and after

Before the order

Reporting was limited and often voluntary, leaving FDA less time to locate alternate supply or accelerate reviews.

After the order

Earlier notices and expedited action became standard, followed by broader statutory reporting duties.

Who had to do what

Agency / officeActionTiming / position
FDAExpedite reviews and coordinate shortage responseContinuing
ManufacturersNotify FDA of covered discontinuances and interruptionsContinuing statutory duty
FDAMaintain public shortage informationContinuing

What happened next

EO 13588 issued.

FDASIA strengthened shortage notification law.