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.

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