FDA de­fends its over­sight of for­eign drugs amid Sen­ate, GAO crit­i­cism

Dur­ing a Sen­ate Com­mit­tee on Fi­nance hear­ing Tues­day, of­fi­cials from the FDA re­spond­ed to crit­i­cism from sen­a­tors and a new re­port from the Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO) on its over­sight of for­eign drug man­u­fac­tur­ers.

The hear­ing fol­lows FDA’s move to halt most for­eign in­spec­tions in March as a re­sult of the coro­n­avirus dis­ease (COVID-19) pan­dem­ic.

Much of the crit­i­cism cen­tered on the agency’s prac­tice of giv­ing for­eign fa­cil­i­ties ad­vanced no­tice of in­spec­tions while most do­mes­tic sur­veil­lance in­spec­tions are unan­nounced, as well as US re­liance on for­eign drug man­u­fac­tur­ing.

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