Reducing Prescription Drug Shortages

This executive order directs the FDA to use existing authority to require earlier notice from manufacturers about drug discontinuances that could cause shortages, expedite regulatory reviews when shortages are threatened, and refer evidence of price gouging or hoarding to the Department of Justice for potential enforcement. It responds to a near-tripling of prescription drug shortages between 2005 and 2010, particularly for cancer treatments and anesthesia drugs.

Federal Register Open PDF 76 FR 68295

Key directives

FDA shall use all appropriate administrative tools to require manufacturers to provide adequate advance notice of manufacturing discontinuances under 21 U.S.C. 356c
FDA shall expand efforts to expedite regulatory reviews of new suppliers, manufacturing sites, and manufacturing changes when expedited review would help avoid or mitigate shortages
FDA shall prioritize based on severity of shortage and importance to public health
FDA shall communicate to DOJ any findings of stockpiling or exorbitant pricing during shortages
DOJ shall determine legality of such activities and undertake appropriate enforcement actions

Who is ordered

Timeline

Immediate

FDA instructed to begin using administrative tools for broader reporting requirements
FDA to expand expedited regulatory review efforts
FDA to communicate shortage-related market abuses to DOJ

Near term (90d)

FDA implementation of broader manufacturing discontinuance reporting using 21 U.S.C. 356c authority
Potential DOJ review of market participant behaviors referred by FDA

Long term

Potential reduction in drug shortages through earlier manufacturer notification
Possible expansion of drug manufacturing capacity (noted as multi-year process)
Continued monitoring of market behavior for hoarding and price gouging

Risks & tensions

No specific calendar deadlines or 'within N days' timelines specified—implementation speed depends on FDA administrative discretion and 'extent permitted by law'
EO relies on existing statutory authority (21 U.S.C. 356c) rather than creating new legal requirements; effectiveness constrained by current law
'To the extent practicable' and 'to the extent permitted by law' language creates uncertainty about binding force
Subject to appropriations limitation may constrain resource-intensive expedited reviews
Manufacturer compliance with voluntary/expanded reporting remains uncertain without statutory mandate