Last week’s US Senate hearing on securing the pharmaceutical supply
chain put drug safety in the spotlight and illuminated a significant
challenge for the pending Prescription Drug User Fee Act (PDUFA)
reauthorization: how to address safety concerns while also alleviating
critical drug shortages. The US Food and Drug Administration (FDA) wants
more authority to police drugs and drug products entering the US from
around the world, but must also take steps to address drug shortages,
which Deputy Commissioner for Global Regulatory Operations and Policy
Deborah Autor called a “complex economic problem.” Autor argued that
track-and-trace technology would help FDA address resulting public
health risks and respond accordingly and that the agency needs authority
to mandate track-and-trace useage.
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