Califf lays out drug shortage landscape, talks post-market data collection for accelerated approvals

Ef­forts to in­spect gener­ic drug fa­cil­i­ties around the world could end up wors­en­ing US short­ages of sev­er­al key med­i­cines if they lead to halt­ed man­u­fac­tur­ing, said FDA Com­mis­sion­er Robert Califf, un­der­scor­ing the chal­lenges faced by the agency on drug sup­ply is­sues.

Califf, speak­ing at a vir­tu­al event host­ed by Reuters, said that the FDA’s in­spec­tion work could ac­tu­al­ly lead to more short­ages if in­spec­tors find is­sues that lead to man­u­fac­tur­ing lines be­ing shut down.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.