FDA in­spec­tion back­log tops 1,000 — and could last for years — as House hear­ing rais­es se­ri­ous con­cerns

A US House of Rep­re­sen­ta­tives sub­com­mit­tee on Tues­day reignit­ed bi­par­ti­san angst around the FDA’s drug man­u­fac­tur­ing in­spec­tion back­log and at­tempts to im­prove its in­spec­tions process over­seas.

The pan­dem­ic has forced the FDA to for­go more than 1,000 of its planned fis­cal year 2020 in­spec­tions and the agency will like­ly face a back­log of fu­ture in­spec­tions for years to come, ac­cord­ing to tes­ti­mo­ny from Mary Deni­gan-Macauley, di­rec­tor of health care at the Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO).

Endpoints News

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.