US contemplates changes to prevent another tainted heparin-like event
This article was originally published in SRA
Executive Summary
At a time when Republicans are seeking to cut more than $240 million from the US Food and Drug Administration's budget, the agency is facing an enormous challenge keeping up with inspections of foreign facilities where US drugs are made – with the number of those sites increasing 185% over the past decade – while also combating the rising problem of counterfeit medicines reaching the US supply chain.